A Phase 1/2 interventional study of ASP546C in Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma and Pancreatic Adenocarcinoma, sponsored by Astellas Pharma Global Development, Inc.. Recruiting at 21 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Astellas Pharma Global Development, Inc. (part of Astellas Pharma Inc) · Phase 1/2, Interventional, and Treatment
Among 12 studies in Adenocarcinoma by Astellas Pharma Inc — 7 open to participants now, 9 under way, 4 of them phase 3. Adenocarcinoma · Astellas Pharma Inc.
Among the 12 studies in Adenocarcinoma by Astellas Pharma Inc, this one is one of 3 that started in 2026, is the only one in phase 1/2, and was the 9th registered.
620 studies on the registry are indexed under Adenocarcinoma; 148 are open to participants now.
Browse Adenocarcinoma studies →7 of the 12 studies in Adenocarcinoma by Astellas Pharma Inc are open now, in 12 countries. Recruiting first, the newest first:
Astellas Pharma Global Development, Inc. · Sites in United States, China, Japan and 1 more country
Ages 18+
Astellas Pharma Global Development, Inc. · Sites in United States, Australia, Belgium and 19 more countries
Ages 18+
Astellas Pharma Korea, Inc. · Sites in Korea, Republic of
Astellas Pharma Global Development, Inc. · Sites in United States, China, France and 5 more countries
Ages 18+
Astellas Pharma Europe Ltd. · Sites in Canada
Ages 18+
By country, each count listing its studies:
Of the 110 Adenocarcinoma studies recruiting now, 81 (74%) set no upper age limit and 11 (10%) stop at 75 or younger; 7 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 1 · Phase 3 4 · Phase 4 1
First in 2010; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above the median of 57 across 490 interventional studies indexed under Adenocarcinoma.
Median enrollment 398 across the 9 interventional studies, 689 across the 2 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Astellas Pharma Global Development, Inc., one of the names counted as Astellas Pharma Inc. Under that name alone:
Astellas Pharma Global Development, Inc. is the lead sponsor of 207 studies on the registry; 23 are open to participants now.
Of its 82 completed or terminated interventional studies of FDA-regulated products, 38 (46%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Adenocarcinoma by Astellas Pharma Inc, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors. GEJ is where the food pipe (esophagus) joins the stomach.
This study is in 2 parts. In both parts of the study, ASP546C will be given once in 3-week cycles. It will be given slowly through a tube into a vein. This is called an infusion.
In Part 1, people with gastric cancer or GEJ cancer can take part. They will receive an infusion of either a higher dose or a lower dose of ASP546C.
In Part 2, people with pancreatic cancer or who have one of the other solid tumors can take part. Part 2 doesn't include people with gastric cancer or GEJ cancer. All people in this part of the study will receive an infusion of the higher dose of ASP546C.
People will visit the clinic on certain days to receive ASP546C and have health checks. The number of visits and checks done during the study will depend on the health of each person and whether they are still receiving infusions of ASP546C.
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.
Female participant is not pregnant and at least 1 of the following conditions apply:
Exclusion Criteria:
Cohorts 1, 2 and 3 only: Participant has received > 2 for uLA/m disease.
Participant has a known history of a positive test for (HIV) infection or known active (positive hepatitis B surface antigen [HBsAg]) or infection. Screening for these infections should be conducted if indicated per local requirements.
Participant has significant cardiovascular disease, including any of the following:
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.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
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.
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.
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.
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Participants with unresectable locally advanced or metastatic (uLA/m) gastroesophageal adenocarcinoma will receive a lower dose of ASP546C intravenously, once every 3 weeks (Q3W).
Drug: ASP546C
Participants with uLA/m gastroesophageal adenocarcinoma will receive a higher dose of ASP546C intravenously, once Q3W.
Drug: ASP546C
Participants with uLA/m pancreatic adenocarcinoma will receive a higher dose of ASP546C intravenously, once Q3W.
Drug: ASP546C
Participants with pan-tumor (cholangiocarcinoma, colorectal adenocarcinoma, NSCLC, SCLC, ovarian mucinous carcinoma or invasive breast cancer) will receive a higher dose of ASP546C intravenously, once Q3W.
Drug: ASP546C
Intravenous administration
Also known as: XNW27011
Part 1: Objective Response Rate (ORR) per Investigator-assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR is defined as the proportion of participants who have a best overall response (BOR) of complete response (CR) or partial response (PR) as per investigator assessment per RECIST v1.1.
Time frame: Up to 36 Months
Part 1: Pharmacokinetics (PK) of ASP546C Antibody-drug Conjugate (ADC): Serum Concentrations of Antibody-drug Conjugate
ADC concentrations will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1: PK of ASP546C ADC: Maximum Concentration (Cmax)
Cmax will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1: PK of ASP546C ADC: Area Under the Serum Concentration-time Curve from Time Zero to 21Days (AUC0-21d)
AUC0-21d will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1: Number of participants with Adverse events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Time frame: Up to 39 Months
Part 1: Number of Participants with Vital Sign Abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 39 Months
Part 1: Number of Participants with Laboratory Value Abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 39 Months
Part 1: Number of Participants at Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Time frame: Up to 39 Months
Part 1 and Part 2: ORR per Investigator-assessed per RECIST v1.1
ORR is defined as the proportion of participants who have a BOR of CR or PR as per investigator assessment per RECIST v1.1.
Time frame: Up to 36 Months
Part 1 and Part 2: Disease Control Rate (DCR) per Investigator-assessed per RECIST v1.1
DCR defined as the proportion of participants with a BOR of CR, PR or stable disease (SD) as per investigator assessment per RECIST v1.1.
Time frame: Up to 36 Months
Part 1 and Part 2: Duration of Response (DOR) per Investigator-assessed per RECIST v1.1
DOR is defined as the time from the date of the first response (CR/PR) until the date of radiologic disease progression as per investigator assessment per RECIST v1.1 or date of death from any cause, whichever is earlier.
Time frame: Up to 36 Months
Part 1 and Part 2: Progression Free Survival (PFS) per Investigator-assessed per RECIST v1.1
PFS is defined as the time from the date of first dose until the date of radiologic disease progression as per investigator assessment per RECIST v1.1 or death from any cause, whichever is earlier.
Time frame: Up to 39 Months
Part 1 and Part 2: Overall Survival (OS)
OS is defined as the time from the date of first dose until the documented date of death from any cause
Time frame: Up to 39 Months
Part 2: Number of Participants with AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Time frame: Up to 39 Months
Part 2: Number of Participants with Vital Sign Abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 39 Months
Part 2: Number of Participants with Laboratory Value Abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 39 Months
Part 2: Number of Participants at Each Grade of ECOG Performance Status Scores
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Time frame: Up to 39 Months
Part 1 and Part 2: Change from baseline in Expression Levels of Claudin 18.2 (CLDN18.2)
Comparison of CLDN18.2 expression at baseline versus on-treatment tumor biopsies will be performed.
Time frame: Baseline and up to Day 58
Part 1 and Part 2: PK of ASP546C ADC: Concentration at the End of Infusion (CEOI)
CEOI will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: CEOI
CEOI will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: CEOI
CEOI will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 2: PK of ASP546C ADC: AUC0-21d
AUC0-21d will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: AUC0-21d
AUC0-21d will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: AUC0-21d
AUC0-21d will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C ADC: Trough Concentration (Ctrough)
Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: Ctrough
Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: Ctrough
Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C ADC: Time of Maximum Concentration (tmax)
tmax will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: tmax
tmax will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: tmax
tmax will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C ADC: Terminal Elimination Half-life (t1/2)
t1/2 will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: t1/2
t1/2 will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: t1/2
t1/2 will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C ADC: Clearance (CL)
CL will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: CL
CL will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: CL
CL will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C ADC: Volume of Distribution at Steady State (Vss)
Vss will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: Vss
Vss will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: Vss
Vss will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: Number of Participants with all Anti-drug Antibodies (Total Antibody and ADC) Against ASP546C
Number of participants with anti-drug antibodies will be reported.
Time frame: Up to 22 Months
Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Data sharing details ↗ · www.clinicaltrials.astellas.com
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jul 2029, 38 months after the start.
Of 33 phase 1/2 interventional studies under Adenocarcinoma, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 84. This study's planned 38 months is below that.
How these figures are worked out, and which studies are left out of them.
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