A Phase 1 interventional study of SKL35501 and SKL35502 in Selected Advanced Solid Tumors, Colorectal Cancer (CRC) and Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by SK Life Science, Inc.. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by SK Life Science, Inc. (part of SK Biopharmaceuticals) · Phase 1, Interventional, and Treatment
Among 282 studies in Colorectal Neoplasms with a site in Korea, Republic of — 60 open to participants now, 96 under way, 12 of them phase 3. Colorectal Neoplasms · Korea, Republic of.
Among the 282 studies in Colorectal Neoplasms with a site in Korea, Republic of, this one is the 144th largest by planned enrollment of the 250 interventional ones that give a count, is one of 9 that started in 2026, is one of 53 in phase 1, reaches primary completion later than 93 of the 95 other live ones, and was the 281st registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 100 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →60 of the 282 studies in Colorectal Neoplasms with a site in Korea, Republic of are open now, in 12 countries. Each count lists the studies.
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →282 studies; the count open now beside each. This study's row is marked.
First in 1991; this study’s year is marked. 9 started in 2026.
Median enrollment 145 across the 250 interventional studies, 682 across the 32 observational. Of the 152 that completed or were terminated, 56 (37%) have results posted.
170 of 282 have an industry lead sponsor. The 10 most frequent:
SK Life Science, Inc. is the lead sponsor of 43 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 2 (14%) have results posted.
SK Life Science, Inc. has 1 study filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
27 of the studies in Colorectal Neoplasms with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05093907BeyondBio Inc.A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer | 2026-11-30 |
| NCT05784688TiumBio Co., Ltd.Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors | 2026-12 |
| NCT04585750PMV Pharmaceuticals, IncThe Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) | 2026-12-15 |
| NCT06769087Seoul St. Mary's HospitalComparing Immediate Removal and Postoperative 1 Day of Urinary Catheter After Colorectal Cancer Surgery | 2026-12-31 |
| NCT07380867Seoul St. Mary's HospitalConfirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorectal Cancer Surgery. | 2026-12-31 |
Among the 282 studies in Colorectal Neoplasms with a site in Korea, Republic of, from their registry updates:
This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors. SKL35502 is an imaging agent used with SPECT scans to identify tumors with neurotensin receptor 1 (NTSR1), a protein found on some cancer cells, and to assess where the agent travels in the body and the radiation dose delivered to tissues. Participants with sufficient SKL35502 tumor uptake may receive SKL35501, a treatment designed to deliver targeted alpha radiation to NTSR1-expressing tumor cells.
Part A will evaluate the safety and imaging performance of SKL35502 and the safety, tolerability, pharmacokinetics, biodistribution, dosimetry, and biologically active dose range of SKL35501, as well as preliminary antitumor activity. Part B will further evaluate selected SKL35501 dose levels, including randomized low- and high-dose groups in participants with colorectal cancer, and will expand evaluation in selected tumor types. The study will also examine relationships among SKL35502 imaging, NTSR1 expression, SKL35501 tumor uptake, and treatment outcomes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all the following criteria apply:
Patients with secondary metastasis to the CNS are eligible if they have had all resected or have received radiation therapy ending at least 4 weeks prior to C1D1 and they meet all of the following criteria:
Willing to follow the requirements as outlined:
For females:
:
For males:
Adequate hematologic and end-organ function, defined based on the following laboratory results obtained within (≤) 14 days prior to C1D1:
Exclusion Criteria
Patients are excluded from the study if any of the following criteria apply:
Medical Conditions:
History of and/or current cardiovascular events or conditions:
Positive tests at screening for the following:
i. HBcAb: Patients with a positive HBcAb test followed by a negative HBV DNA test at screening may be enrolled.
ii. antibody test: Patients with a positive HCV antibody test followed by a negative HCV RNA test at screening may be enrolled.
Active thrombophlebitis, thromboembolism, hypercoagulability states, bleeding:
Any other significant co-morbidity, disease, metabolic dysfunction, physical examination, or clinical laboratory finding that contraindicates the use of an drug, or may represent an unacceptable risk from treatment complications, or may affect adherence to the study procedures or the interpretation of the results.
Ineligible prior and ongoing treatment requirements:
Any other therapy that is prohibited during the study. Refer to Section 6.9.1.
Other Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Description: For dose optimization, one cohort with 2 groups (Low Dose SKL35501 group and High Dose SKL35501 group) will be initiated in part B of the study
Drug: SKL35501 · Diagnostic Test: SKL35502
Description: For dose optimization, one cohort with 2 groups (Low Dose SKL35501 group and High Dose SKL35501 group) will be initiated in part B of the study
Drug: SKL35501 · Diagnostic Test: SKL35502
Therapeutic agent that consists of an NTSR1-targeting small molecule linked to alpha emitter 225Ac to induce killing of NTSR1-expressing tumor cells
Imaging agent that consists of an NTSR1-targeting small molecule linked to 111In to detect NTSR1-expressing tumors via SPECT imaging
Number of Participants With Treatment-Emergent Adverse Events Following SKL35502 Administration
The number of participants with at least one treatment-emergent adverse event following administration of SKL35502 will be reported. A treatment-emergent adverse event is an adverse event that begins or worsens after the first administration of SKL35502. Adverse-event severity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 6.0. Each participant will be counted once for this outcome regardless of the number of events experienced.
Time frame: From the first administration of SKL35502 until initiation of SKL35501, 15 days after the last administration of SKL35502, or initiation of a new antitumor therapy, whichever occurs first.
Absorbed Radiation Dose to Prespecified Normal Organs Following SKL35502 Administration
Absorbed radiation dose will be estimated for each prespecified normal organ following SKL35502 administration using serial imaging, organ time-activity data, and protocol-defined dosimetry methods. Organ-specific absorbed-dose values will be reported separately using the same protocol-defined absorbed-dose unit.
Time frame: From SKL35502 administration through 7 days after administration.
Absorbed Radiation Dose to Evaluable Tumor Lesions Following SKL35502 Administration
Absorbed radiation dose will be estimated for each evaluable tumor lesion following SKL35502 administration using serial imaging, lesion time-activity data, and protocol-defined dosimetry methods. Lesion-specific absorbed-dose values will be reported separately using the same protocol-defined absorbed-dose unit.
Time frame: From SKL35502 administration through 7 days after administration.
Whole-Body Radiation Dose Following SKL35502 Administration
The whole-body radiation dose following SKL35502 administration will be estimated using serial imaging and protocol-defined dosimetry methods. One whole-body radiation-dose value will be reported for each evaluable participant using the protocol-defined unit.
Time frame: From SKL35502 administration through 7 days after administration.
Number of Participants With Dose-Limiting Toxicities During Cycle 1 Following the First Dose of SKL35501
The number of participants who experience at least one SKL35501-related dose-limiting toxicity during the protocol-defined dose-limiting toxicity assessment period will be reported. Dose-limiting toxicities are protocol-defined hematologic or non-hematologic adverse events occurring during the first treatment cycle. Each participant will be counted once regardless of the number of dose-limiting toxicities experienced.
Time frame: From the first administration of SKL35501 through the end of Cycle 1, a period of 6 weeks.
Lower SKL35501 Administered Activity Selected for the Biologically Active Dose Range for Part B
The lower SKL35501 administered activity selected for the biologically active dose range will be determined by the Safety Review Committee based on integrated review of dose-limiting toxicities, safety and tolerability beyond the dose-limiting toxicity assessment period, pharmacokinetics, pharmacodynamics, imaging, dosimetry, and preliminary antitumor activity. One lower administered-activity value will be reported in megabecquerels.
Time frame: At completion of Part A dose escalation and backfill, after all Part A participants have completed at least one 6-week treatment cycle.
Upper SKL35501 Administered Activity Selected for the Biologically Active Dose Range for Part B
The upper SKL35501 administered activity selected for the biologically active dose range will be determined by the Safety Review Committee based on integrated review of dose-limiting toxicities, safety and tolerability beyond the dose-limiting toxicity assessment period, pharmacokinetics, pharmacodynamics, imaging, dosimetry, and preliminary antitumor activity. One upper administered-activity value will be reported in megabecquerels.
Time frame: At completion of Part A dose escalation and backfill, after all Part A participants have completed at least one 6-week treatment cycle.
Tumor-to-Background Ratio of SKL35502 Uptake in RECIST Version 1.1 Measurable Tumor Lesions
Tumor-to-background ratio will be calculated as SKL35502 uptake in an anatomically matched RECIST Version 1.1 measurable tumor lesion divided by uptake in the background reference region defined in the Imaging Charter or Imaging Manual. Tumor-to-background ratio values will be summarized separately at each protocol-specified imaging time point.
Time frame: From SKL35502 administration through 144 hours after administration.
Number of Participants With at Least One SKL35502-Positive RECIST Version 1.1 Measurable Tumor Lesion
The number of participants with at least one anatomically matched RECIST Version 1.1 measurable tumor lesion demonstrating focal SKL35502 uptake above the Imaging Charter-defined background region will be reported. Positivity will be assessed by a qualified nuclear medicine physician or radiologist using the protocol-defined visual and quantitative imaging criteria.
Time frame: From SKL35502 administration through 144 hours after administration.
SKL35502 Imaging Time Point Selected for Tumor Eligibility Assessment
The imaging time point selected for tumor eligibility assessment will be determined based on integrated review of tumor visualization, tumor-to-background ratio, normal-tissue uptake, image quality, biodistribution, and operational feasibility. One selected imaging time point will be reported as the number of hours after SKL35502 administration.
Time frame: At completion of the Part A SKL35502 imaging review following collection of imaging data through 144 hours after administration.
Percentage of Participants With Complete Response, Partial Response, or Stable Disease Lasting at Least 4 Months Following SKL35501 Treatment
The percentage of efficacy-evaluable participants whose best overall response is complete response or partial response, or whose stable disease lasts for at least 4 months, will be reported. Tumor response will be assessed by the Investigator according to RECIST Version 1.1 and, where applicable, RANO-BM for brain metastases.
Time frame: Tumor assessments will be performed every 8 weeks during the first 6 months and every 12 weeks thereafter, up to 12 months after the last participant's first SKL35501 dose.
Objective Response Rate Following SKL35501 Treatment
Objective response rate is the percentage of efficacy-evaluable participants whose best overall response is complete response or partial response, as assessed by the Investigator according to RECIST Version 1.1 and, where applicable, RANO-BM for brain metastases.
Time frame: Tumor assessments will be performed every 8 weeks during the first 6 months and every 12 weeks thereafter, up to 12 months after the last participant's first SKL35501 dose.
Clinical Benefit Rate Following SKL35501 Treatment
Clinical benefit rate is the percentage of efficacy-evaluable participants whose best overall response is complete response, partial response, or stable disease, as assessed by the Investigator according to RECIST Version 1.1 and, where applicable, RANO-BM for brain metastases.
Time frame: Tumor assessments will be performed every 8 weeks during the first 6 months and every 12 weeks thereafter, up to 12 months after the last participant's first SKL35501 dose.
Progression-Free Survival Following SKL35501 Treatment
Progression-free survival is defined as the time from the first administration of SKL35501 to the first documented disease progression, as determined by the Investigator according to RECIST Version 1.1 and, where applicable, RANO-BM for brain metastases, or death from any cause, whichever occurs first.
Time frame: From the first SKL35501 dose until documented disease progression, death, or completion of protocol-defined efficacy follow-up, up to 12 months after the last participant's first SKL35501 dose.
Time to Disease Progression Following SKL35501 Treatment
Time to disease progression is defined as the time from the first administration of SKL35501 to the first documented disease progression, as determined by the Investigator according to RECIST Version 1.1 and, where applicable, RANO-BM for brain metastases.
Time frame: From the first SKL35501 dose until documented disease progression or completion of protocol-defined efficacy follow-up, up to 12 months after the last participant's first SKL35501 dose.
Overall Survival Following SKL35501 Treatment
Overall survival is defined as the time from the first administration of SKL35501 to death from any cause.
Time frame: From the first SKL35501 dose until death, loss to follow-up, withdrawal of consent, or completion of protocol-defined survival follow-up, up to 12 months after the last participant's first SKL35501 dose.
Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events Following SKL35502 Administration
The number of participants with at least one Grade 3 or higher treatment-emergent adverse event following administration of SKL35502 will be reported. Severity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 6.0. Each participant will be counted once regardless of the number of events experienced.
Time frame: From the first administration of SKL35502 until initiation of SKL35501, 15 days after the last administration of SKL35502, or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Serious Adverse Events Following SKL35502 Administration
The number of participants with at least one serious adverse event following administration of SKL35502 will be reported. Each participant will be counted once regardless of the number of serious adverse events experienced.
Time frame: From the first administration of SKL35502 until initiation of SKL35501, 15 days after the last administration of SKL35502, or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Adverse Events of Special Interest Following SKL35502 Administration
The number of participants with at least one protocol-defined adverse event of special interest following administration of SKL35502 will be reported. Each participant will be counted once regardless of the number of adverse events of special interest experienced.
Time frame: From the first administration of SKL35502 until initiation of SKL35501, 15 days after the last administration of SKL35502, or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Clinically Significant 12-Lead Electrocardiogram Abnormalities Following SKL35502 Administration
The number of participants with at least one clinically significant abnormality or clinically significant change from baseline in heart rate, cardiac rhythm, PR interval, QRS duration, QT interval, or QT interval corrected using Fridericia's formula will be reported. Clinical significance will be determined by the Investigator. Each participant will be counted once for this outcome.
Time frame: From baseline until initiation of SKL35501, 15 days after the last administration of SKL35502, or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Clinically Significant Vital-Sign Abnormalities Following SKL35502 Administration
The number of participants with at least one protocol-defined clinically significant vital-sign abnormality or clinically significant change from baseline following SKL35502 administration will be reported. Each participant will be counted once regardless of the number of vital-sign abnormalities experienced.
Time frame: From baseline until initiation of SKL35501, 15 days after the last administration of SKL35502, or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Clinically Significant Physical Examination Findings Following SKL35502 Administration
The number of participants with at least one clinically significant new or worsened physical examination finding following SKL35502 administration will be reported. Clinical significance will be determined by the Investigator. Each participant will be counted once for this outcome.
Time frame: From baseline until initiation of SKL35501, 15 days after the last administration of SKL35502, or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Clinically Significant Safety Laboratory Abnormalities Following SKL35502 Administration
The number of participants with at least one clinically significant hematology or clinical chemistry laboratory abnormality or clinically significant change from baseline following SKL35502 administration will be reported. Laboratory abnormalities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 6.0, where applicable. Each participant will be counted once for this outcome.
Time frame: From baseline until initiation of SKL35501, 15 days after the last administration of SKL35502, or initiation of a new antitumor therapy, whichever occurs first.
Total Radioactivity Concentration in Whole Blood Following SKL35502 Administration
Total radioactivity concentration in whole blood will be measured and summarized separately at each protocol-specified collection time following SKL35502 administration.
Time frame: From predose through 144 hours after SKL35502 administration.
Total Radioactivity Concentration in Plasma Following SKL35502 Administration
Total radioactivity concentration in plasma will be measured and summarized separately at each protocol-specified collection time following SKL35502 administration.
Time frame: From predose through 144 hours after SKL35502 administration.
Total Radioactivity Concentration in Urine Following SKL35502 Administration
Total radioactivity concentration in urine will be measured and summarized separately for each protocol-specified urine collection interval following SKL35502 administration.
Time frame: From predose through 72 hours after SKL35502 administration.
Correlation Coefficient Between SKL35502 Tumor-to-Background Ratio and Tumor NTSR1 Expression
SKL35502 tumor uptake will be represented by the tumor-to-background ratio for an evaluable tumor lesion. Tumor NTSR1 expression will be represented by the protocol-specified quantitative result obtained from corresponding tumor tissue when available. One protocol-specified correlation coefficient describing the association between tumor-to-background ratio and tumor NTSR1 expression will be reported.
Time frame: After completion of the corresponding tumor tissue assessment and SKL35502 imaging assessments, with imaging performed through 144 hours after SKL35502 administration.
Number of Participants With Treatment-Emergent Adverse Events Following SKL35501 Administration
The number of participants with at least one treatment-emergent adverse event following administration of SKL35501 will be reported. A treatment-emergent adverse event is an adverse event that begins or worsens after the first administration of SKL35501. Severity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 6.0. Each participant will be counted once for this outcome. Results will be summarized by applicable Part A dose cohort and Part B dose group, including participants treated at the biologically active dose range.
Time frame: From the first administration of SKL35501 through 50 days after the last administration of SKL35501 or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events Following SKL35501 Administration
The number of participants with at least one Grade 3 or higher treatment-emergent adverse event following administration of SKL35501 will be reported. Severity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 6.0. Each participant will be counted once regardless of the number of events experienced.
Time frame: From the first administration of SKL35501 through 50 days after the last administration of SKL35501 or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Serious Adverse Events Following SKL35501 Administration
The number of participants with at least one serious adverse event following administration of SKL35501 will be reported. Each participant will be counted once regardless of the number of serious adverse events experienced.
Time frame: From the first administration of SKL35501 through 50 days after the last administration of SKL35501 or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Adverse Events of Special Interest Following SKL35501 Administration
The number of participants with at least one protocol-defined adverse event of special interest following administration of SKL35501 will be reported. Each participant will be counted once regardless of the number of adverse events of special interest experienced.
Time frame: From the first administration of SKL35501 through 50 days after the last administration of SKL35501 or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Clinically Significant 12-Lead Electrocardiogram Abnormalities Following SKL35501 Administration
The number of participants with at least one clinically significant abnormality or clinically significant change from baseline in heart rate, cardiac rhythm, PR interval, QRS duration, QT interval, or QT interval corrected using Fridericia's formula will be reported. Clinical significance will be determined by the Investigator. Each participant will be counted once for this outcome.
Time frame: From baseline through 50 days after the last administration of SKL35501 or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Clinically Significant Vital-Sign Abnormalities Following SKL35501 Administration
The number of participants with at least one protocol-defined clinically significant vital-sign abnormality or clinically significant change from baseline following SKL35501 administration will be reported. Each participant will be counted once regardless of the number of vital-sign abnormalities experienced.
Time frame: From baseline through 50 days after the last administration of SKL35501 or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Clinically Significant Physical Examination Findings Following SKL35501 Administration
The number of participants with at least one clinically significant new or worsened physical examination finding following SKL35501 administration will be reported. Clinical significance will be determined by the Investigator. Each participant will be counted once for this outcome.
Time frame: From baseline through 50 days after the last administration of SKL35501 or initiation of a new antitumor therapy, whichever occurs first.
Number of Participants With Clinically Significant Safety Laboratory Abnormalities Following SKL35501 Administration
The number of participants with at least one clinically significant hematology or clinical chemistry laboratory abnormality or clinically significant change from baseline following SKL35501 administration will be reported. Laboratory abnormalities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 6.0, where applicable. Each participant will be counted once for this outcome.
Time frame: From baseline through 50 days after the last administration of SKL35501 or initiation of a new antitumor therapy, whichever occurs first.
Total Radioactivity Concentration in Whole Blood Following SKL35501 Administration
Total radioactivity concentration in whole blood will be measured and summarized separately at each protocol-specified collection time following SKL35501 administration.
Time frame: From predose through 168 hours after SKL35501 administration in Cycles 1 and 3, with additional samples collected on Day 1 of Cycles 2 and 4. Each treatment cycle is 6 weeks.
Total Radioactivity Concentration in Plasma Following SKL35501 Administration
Total radioactivity concentration in plasma will be measured and summarized separately at each protocol-specified collection time following SKL35501 administration.
Time frame: From predose through 168 hours after SKL35501 administration in Cycles 1 and 3, with additional samples collected on Day 1 of Cycles 2 and 4. Each treatment cycle is 6 weeks.
Total Radioactivity Concentration in Urine Following SKL35501 Administration
Total radioactivity concentration in urine will be measured and summarized separately for each protocol-specified urine collection interval following the Cycle 1 administration of SKL35501.
Time frame: From predose through 72 hours after the Cycle 1 SKL35501 dose. Cycle 1 is 6 weeks.
Duration of Response Following SKL35501 Treatment
For participants whose best overall response is complete response or partial response, duration of response is defined as the time from the first documented complete response or partial response to the first documented disease progression, as determined by the Investigator according to RECIST Version 1.1 and, where applicable, RANO-BM for brain metastases, or death from any cause, whichever occurs first.
Time frame: From the first documented complete response or partial response until documented disease progression, death, or completion of protocol-defined efficacy follow-up, up to 12 months after the last participant's first SKL35501 dose.
Absorbed Radiation Dose to Prespecified Normal Organs Following SKL35501 Administration
Absorbed radiation dose will be estimated for each prespecified normal organ, including high-uptake and critical tissues such as the kidneys, liver, red marrow, and spleen, using serial imaging, organ time-activity data, and protocol-defined dosimetry methods. Organ-specific values will be reported separately using the same protocol-defined absorbed-dose unit.
Time frame: From the first SKL35501 dose through 168 hours after SKL35501 administration in Cycles 1 and 3. Each treatment cycle is 6 weeks.
Absorbed Radiation Dose to Evaluable Tumor Lesions Following SKL35501 Administration
Absorbed radiation dose will be estimated for each evaluable tumor lesion using serial imaging, lesion time-activity data, and protocol-defined dosimetry methods. Lesion-specific absorbed-dose values will be reported separately using the same protocol-defined absorbed-dose unit.
Time frame: From the first SKL35501 dose through 168 hours after SKL35501 administration in Cycles 1 and 3. Each treatment cycle is 6 weeks.
Cumulative Absorbed Radiation Dose to Prespecified Normal Organs Across SKL35501 Treatment Cycles
The cumulative absorbed radiation dose to each prespecified normal organ will be estimated across all SKL35501 treatment cycles received by the participant using protocol-defined dosimetry methods. Organ-specific cumulative absorbed-dose values will be reported separately using the same protocol-defined absorbed-dose unit.
Time frame: From the first SKL35501 dose through completion of up to 4 treatment cycles, up to approximately 24 weeks. Each treatment cycle is 6 weeks.
Maximum Absorbed Radiation Dose Among Prespecified Normal Organs Following SKL35501 Administration
For each evaluable participant, the highest absorbed radiation dose among the prespecified normal organs will be determined from the organ-specific dosimetry results. One maximum normal-organ absorbed-dose value will be reported for each participant using the protocol-defined absorbed-dose unit.
Time frame: From the first SKL35501 dose through completion of dosimetry assessments in Cycles 1 and 3, with serial imaging through 168 hours after each dose. Each treatment cycle is 6 weeks.
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Start is estimated for Aug 2026; primary completion for Jul 2030, 47 months later.
Of 268 industry-sponsored phase 1 interventional studies under Colorectal Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's planned 47 months is close to that.
Counting every sponsor, half of 434 studies reached it within 48 months; a quarter within 31 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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