A Phase 1/2 interventional study of DES-1357 in Metastatic Colorectal Cancer (CRC), sponsored by D. E. Shaw Research, LLC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by D. E. Shaw Research, LLC · Phase 1/2, Interventional, and Treatment
This study is conducted sequentially in 3 parts. The primary objective for Part 1 is to determine the maximum tolerated dose of DES-1357 in participants with confirmed dMMR/MSI-H colorectal cancer (CRC). The primary objective for Part 2 is to assess the chronic tolerability and to identify the recommended Phase 2 dose (RP2D), to evaluate preliminary antitumor activity of the selected dose level of DES-1357, and to assess the pharmacokinetics (PK) and pharmacodynamics of DES-1357. The primary objective for Part 3 is to evaluate antitumor activity of the selected dose level of DES-1357.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 88 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with D. E. Shaw Research, LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Individuals must meet all of the following criteria to be included in the study:
Adequate organ function:
have undergone a documented hysterectomy, bilateral oophorectomy and/or bilateral salpingectomy; have medically confirmed ovarian failure, or achieved status (defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, or have a serum follicle-stimulating hormone level within the laboratory's reference range for postmenopausal women).
Exclusion Criteria:
Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study:
Has active or uncontrolled or C infection. Participants are eligible if they:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
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 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).
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.
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.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
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.
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).
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.
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.
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.
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.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
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.
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.
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.
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.
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.
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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive DES-1357 orally once daily (QD) in 21-day treatment cycles with a starting dose of 150 milligrams (mg). The planned escalation dose levels are 300 and 600 mg to identify the maximum tolerated dose (MTD) for DES-1357.
Drug: DES-1357
Participants will receive DES-1357 orally QD in Dosing Schedule A. The dosing schedules will be selected based on the escalation ranges of Part 1, to determine the RP2D for expansion in Part 3.
Drug: DES-1357
Participants will receive DES-1357 orally QD in Dosing Schedule B. The dosing schedules will be selected based on the escalation ranges of Part 1, to determine the RP2D for expansion in Part 3.
Drug: DES-1357
Participants will receive DES-1357 orally QD at the RP2D determined in Part 2 to further assess its efficacy and safety.
Drug: DES-1357
DES-1357 oral capsules.
Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT is a toxicity that occurs during cycle 1 that meets the protocol-defined DLT criteria and is graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Time frame: Part 1: Cycle 1 (Cycle length=21 days)
Part 2: Incidence and Severity of Treatment- related Treatment Emergent Adverse Events (TEAEs) Through at least 3 Cycles of DES-1357
A TEAE is defined as an AE with onset dates on or after the start of the study treatment or AEs that started prior to the start of the study treatment but worsened in severity after start of the study treatment.
Time frame: Part 2: From the first dose of DES-1357 through at least 3 treatment cycles (Cycle length=21days)
Part 2: Best Overall Response (BOR)
Best overall response is defined as the single best patient level response category (Complete Response \[CR\], Partial Response \[PR\], Stable Disease \[SD\], Progressive disease \[PD\], or Not Evaluable \[NE\]) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Part 2: From baseline through disease progression or end of treatment (EOT); tumor assessments every 8 weeks and at the EOT visit; assessed up to approximately 11 months
Part 2: Maximum Observed Concentration (Cmax) of DES-1357
Time frame: Part 2: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 2: Time to Maximum Concentration (Tmax) of DES-1357
Time frame: Part 2: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 2: Area Under the Curve (AUC) of DES-1357
Time frame: Part 2: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 2: Half Life (t1/2) of DES-1357
Time frame: Part 2: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 2: Clearance (CL) of DES-1357
Time frame: Part 2: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 2: Volume of Distribution (Vd) of DES-1357
Time frame: Part 2: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 2: Change in Pharmacodynamic Markers Levels Following Treatment With DES-1357
Blood and tumor tissue samples will be collected for pharmacodynamic assessments. Biomarker evaluations may include circulating tumor Deoxyribonucleic Acid (ctDNA), carcinoembryonic antigen (CEA), Werner Syndrome Helicase (WRN) expression, phospho-H2AX expression, and other exploratory molecular analyses performed using immunohistochemistry and Ribonucleic Acid (RNA) sequencing methods.
Time frame: Part 2: Blood Samples: At Day 1 (pre-dose) of Cycles 1, 2, 3, 5, 7, and 9; Tumor tissue: At Screening and Cycle 1 Day 15 (±3 days, pre-dose) (Cycle length=21days)
Part 3: Objective Response Rate (ORR) by Independent Review Committee (IRC)
ORR is defined as the percentage of participants with a confirmed objective response (CR or PR) as determined per RECIST Version 1.1.
Time frame: Part 3: From baseline through EOT; tumor assessments every 8 weeks and at the EOT visit; assessed up to approximately 8 months
Part 1: Number of Participants With Treatment-related Adverse Events (AEs) Including TEAEs and Serious AEs
Participants with treatment related AEs, TEAEs and SAEs will be reported, plus treatment-related delays, dose reductions, and/or treatment discontinuations.
Time frame: Part 1: From the first dose of DES-1357 through 30 days after the last dose (Cycle length=21 days)]
Part 2: ORR According to RECIST Version 1.1
ORR is defined as the percentage of participants with a confirmed objective response (CR or PR) as determined per RECIST Version 1.1.
Time frame: Part 2: From baseline through EOT; tumor assessments every 8 weeks and at the EOT visit; assessed up to approximately 11 months
Part 2 and Part 3: Disease Control Rate (DCR) According to RECIST Version 1.1
DCR is defined as the percentage of participants who achieve best response of CR, PR, or SD per RECIST version 1.1.
Time frame: Part 2 and Part 3: From baseline through EOT; tumor assessments every 8 weeks and at the EOT visit; assessed up to approximately 11 months
Part 3: Duration of Response (DOR) According to RECIST Version 1.1
DOR is defined as the time from the first objective response (CR or PR) to the first documented PD per RECIST version 1.1 or death.
Time frame: Part 3: From first documented objective response until first documented PD or death; assessed up to approximately 8 months
Part 1 and Part 3: Maximum Observed Concentration (Cmax) of DES-1357
Time frame: Part 1 and Part 3: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 1 and Part 3: Time to Maximum Concentration (Tmax) of DES-1357
Time frame: Part 1 and Part 3: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 1 and Part 3: Area Under the Curve (AUC) of DES-1357
Time frame: Part 1 and Part 3: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 1 and Part 3: Half Life (t1/2) of DES-1357
Time frame: Part 1 and Part 3: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 1 and Part 3: Clearance (CL) of DES-1357
Time frame: Part 1 and Part 3: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 1 and Part 3: Volume of Distribution (Vd) of DES-1357
Time frame: Part 1 and Part 3: Cycle 1 Day 1: predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose; Cycle 1 Day 15: predose, 1, 2, 4, 8, 12 and 24 hours postdose; Cycle 1 Days 3, 5, and 21: at predose (Cycle length=21 days)
Part 1 and Part 3: Change in Pharmacodynamic Markers Level of DES-1357
Blood and tumor tissue samples will be collected for pharmacodynamic assessments. Biomarker evaluations may include ctDNA, CEA, WRN expression, phospho-H2AX expression, and other exploratory molecular analyses performed using immunohistochemistry and RNA sequencing methods.
Time frame: Part 1 and Part 3: Blood Samples: At Day 1 (pre-dose) of Cycles 1, 2, 3, 5, 7, and 9; Tumor tissue: At Screening and Cycle 1 Day 15 (±3 days, pre-dose) (Cycle length=21days)
Part 2: ORR by an IRC According to RECIST Version 1.1
Part 2: ORR is defined as the percentage of participants with a confirmed objective response (CR or PR) as determined per RECIST Version 1.1.
Time frame: Part 2: From baseline through EOT; tumor assessments every 8 weeks and at the EOT visit; assessed up to approximately 11 months
Part 2: DCR by an IRC According to RECIST Version 1.1
Part 2: DCR is defined as the percentage of participants who achieve best response of CR, PR, or SD per RECIST version 1.1.
Time frame: Part 2: From baseline through EOT; tumor assessments every 8 weeks and at the EOT; assessed up to approximately 11 months
Part 2 and Part 3: Characterization of Biomarker Profiles Following Treatment With DES-1357
Blood and tumor tissue samples will be collected for biomarker analyses. Biomarker assessments may include Deoxyribonucleic Acid (DNA) damage/replication stress markers, ctDNA, WRN expression, and other relevant molecular biomarkers.
Time frame: Part 2 and Part 3: Blood Samples: At Day 1 (pre-dose) of Cycles 1, 2, 3, 5, 7, and 9; Tumor tissue: At Screening and Cycle 1 Day 15 (±3 days, pre-dose) (Cycle length=21days)
Part 3: European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ C30) Questionnaire
Quality-of-life will be assessed through a participant-reported outcome using EORTC QLQ C30
Time frame: Part 3: Screening, and at Cycle 1 Days 1, 8, 15, 21 and at Day 21 for subsequent cycles up to 37 days after last dose of DES-1357 (Cycle length=21days)
Part 3: Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of DES-1357 to the earlier of the date of the first documented disease progression (per RECIST version 1.1) or death due to any cause.
Time frame: Part 3: From first dose of DES-1357 up to first documented disease progression or death; assessed for up to approximately 8 months
Part 3: Overall Survival (OS)
OS is defined as the time from the date of the first dose of study treatment to the date of death due to any cause.
Time frame: Part 3: From first dose of DES-1357 to date of death due to any cause; assessed for up to approximately 8 months
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Plan to share: No
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Start is estimated for Dec 2026; primary completion for Jul 2028, 18 months later.
Of 158 industry-sponsored phase 1/2 interventional studies under Colorectal Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 82. This study's planned 18 months is below that.
Counting every sponsor, half of 260 studies reached it within 59 months; a quarter within 36 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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