AzTrials
AzTrials

Gastric or Gastro-esophageal Junction (GEJ) AdenocarcinomaPhase 1/2NCT07488676

A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors

A Phase 1/2 study testing ASP546C in people with Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma and Pancreatic Adenocarcinoma, run by Astellas Pharma Global Development, Inc. at 21 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ASP546C
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
21 sitesin 2 countries
Study dates
4 May 2026to 31 Jul 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has a histologically confirmed diagnosis of gastroesophageal (gastric/GEJ/esophageal) adenocarcinoma, pancreatic adenocarcinoma, or pan-tumor (cholangiocarcinoma, colorectal adenocarcinoma, NSCLC [adenocarcinoma], SCLC, ovarian mucinous carcinoma or invasive breast cancer [ER/PR+HER2-; ER/PR-HER2+; ER/PR+HER2+ (triple positive); ER/PR-HER2- (triple negative)].
  • Participant has radiologically confirmed uLA/m gastroesophageal (gastric/GEJ/esophageal) adenocarcinoma, pancreatic adenocarcinoma or pan-tumor within 28 days prior to the first dose of study intervention.
  • Cohorts 1 to 3 only: Participant has measurable disease according to RECIST v1.1 within 28 days prior to the first dose of study intervention. For participants with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
  • Cohort 4 only: Participant has radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, within 28 days prior to the first dose of study intervention. For participants with only 1 evaluable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
  • Participant's tumor expresses CLDN18.2.
  • Participant has received at least 1 line of therapy for uLA/m disease.
Show all 19Show fewer
  • Participant has an ECOG performance status of 0 or 1.
  • Participant has a predicted life expectancy >= 12 weeks.
  • Female participant is not pregnant and at least 1 of the following conditions apply:
  • Not a women of childbearing potential (WOCBP)
  • WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 5 half-lives (45 days) plus 6 months after final investigational study intervention administration.
  • Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (45 days) plus 6 months after final investigational study intervention administration.
  • Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 5 half-lives (45 days) plus 6 months after final investigational study intervention administration.
  • Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 5 half-lives (45 days) plus 3 months after final investigational study intervention administration.
  • Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 5 half-lives (45 days) plus 3 months after final investigational study intervention administration.
  • Male participant must not donate sperm during the treatment period and for 5 half-lives (45 days) plus 3 months after final investigational study intervention administration.
  • Participant must meet all of the criteria based on the locally analyzed laboratory tests collected within 14 days prior to the first dose of study intervention. In case of multiple local laboratory tests within this period, the most recent data should be used.
  • Participant is willing to provide or has sufficient tumor tissue for central biomarker assessment.
  • Participant agrees not to participate in another interventional study while receiving study intervention in the present study.

Who cannot join

  • Cohorts 1, 2 and 3 only: Participant's disease is of the non-adenocarcinoma histology or mixed histology containing adenocarcinoma.
  • Cohorts 1, 2 and 3 only: Participant has received > 2 prior lines of therapy for uLA/m disease.
  • Participants in Cohort 4 (pan-tumor) may enroll regardless of the number of prior lines of therapy, if they are not eligible for, decline, or do not have any available standard of care treatment options.
  • Participant has complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.
  • Participant has significant gastric bleeding or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to the first dose of study intervention and/or an untreated peptic ulcer disease that would preclude the participant from participation.
  • Participant has significant bleeding disorders or has had vasculitis within 3 months prior to the first dose of study intervention.
Show all 35Show fewer
  • Participant has a history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of study intervention.
  • Participant has symptomatic, untreated brain metastases or meningeal carcinomatosis (carcinomatous meningitis) from the primary malignancy. A participant with stable central nervous system metastases for > 3 months without need of steroids for >= 2 weeks prior to the first dose of study intervention is eligible.
  • Participant has a past or current mental illness that is difficult to control.
  • Participant has unresolved pneumonitis or a history of non-infectious pneumonitis such as immune-related pneumonitis or radiation-induced pneumonitis for which the participant is taking glucocorticoids or needed glucocorticoids within 6 months prior to the first dose of study intervention.
  • Participant has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection. Screening for these infections should be conducted if indicated per local requirements.
  • If participant is negative for HBsAg, but hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) positive, a hepatitis B DNA test will be performed; if the test is positive, the participant will be excluded.
  • Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results, is eligible.
  • Participant treated for HCV with undetectable viral load results is eligible.
  • Participant has an active infection requiring systemic therapy that has not completely resolved within 7 days prior to the first dose of study intervention.
  • Participant has a malignancy for which treatment is required, has a history of another malignancy within the past 5 years, except malignancies for which participant received curative therapy without recurrence for the last 5 years (e.g., adequately resected non-melanoma skin cancer, localized prostate cancer), or had treatment for carcinoma in situ.
  • Participant has clinically significant third spacing (large amount of pleural fluid or ascites) that requires frequent percutaneous draining or requires placement of a drainage catheter for adequate control.
  • Participant has any AE from prior antitumor treatments that has not yet recovered to grade 0 or 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0 (except alopecia).
  • Participant has an active autoimmune disease or other medical condition that has required high dose systemic steroids at the time of screening.
  • Participant has known peripheral neuropathy > grade 1 (except when the sole neurological abnormality is absence of deep tendon reflexes).
  • Participant has sinusoidal obstruction syndrome, formerly known as veno-occlusive disease; if present, should be stable or improving.
  • Participant has significant cardiovascular disease, including any of the following:
  • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to the first dose of study intervention.
  • History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes), cardiac arrhythmias requiring anti-arrhythmic medications (a participant with rate controlled atrial fibrillation for > 1 month prior to the first dose of study intervention is eligible) or obligate use of cardiac pacemaker.
  • QTc interval > 470 msec
  • Documented history or family history of congenital long QT syndrome.
  • Participant has ongoing or previous interstitial lung disease, active diverticulitis or solid organ or stem cell transplant.
  • Participant has a serious non-healing wound or bone fracture within 28 days prior to study intervention.
  • Participant has had a major surgical procedure within 28 days prior to the first dose of study intervention and has not completely recovered from the surgical procedure <= 14 days prior to the first dose of study intervention.
  • Participant has received chemotherapy, immunotherapy or investigational therapy <= 14 days prior to the first dose of study intervention and has not recovered from any related toxicity. Palliative radiotherapy is allowed and must be completed > 14 days prior to the first dose of study intervention.
  • Participant has received prior CLDN18.2 ADC. Prior treatment with CLDN18.2 monoclonal antibody or bi-specific T-cell engager is allowed.
  • Participant has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
  • Participant has a known or suspected hypersensitivity to ASP546C or any components of the formulation used.
  • Participant has a clinically significant disease or comorbidity that in the opinion of the investigator may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.
  • Cohorts 1 and 2 (gastroesophageal adenocarcinoma) only: Participant has known HER2 positive status defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ hybridization (ISH) +. ISH positive is defined as HER2/ chromosome enumeration probe 17 (CEP17) ratio ≥ 2.0 or an average HER2 copy number ≥ 6.0 signals/cell.

Trial locations and contacts

21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Astellas Pharma Global Development, Inc contact

800-888-7704

Astellas.registration@astellas.com

21 sites in 2 countries

United States18 sites, 18 recruiting

  • Winship Cancer Institute at Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Next Oncology - Austin

    Austin, Texas, 78758

    Recruiting

  • UAB Medicine - UAB Hospital

    Birmingham, Alabama, 35249

    Recruiting

  • Barbara Ann Karmanos Cancer Center

    Detroit, Michigan, 48201

    Recruiting

  • Duke Cancer Center Durham

    Durham, North Carolina, 27710

    Recruiting

  • Inova Schar Cancer Institute Clinical Trials

    Fairfax, Virginia, 22031

    Recruiting

  • START Midwest

    Grand Rapids, Michigan, 49546

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • Next Oncology - Houston

    Houston, Texas, 77054

    Recruiting

  • Indiana University (IU) Health - Multi-D Oncology Clinic

    Indianapolis, Indiana, 46202

    Recruiting

  • Next Oncology - Dallas

    Irving, Texas, 75039

    Recruiting

  • START New York

    Lake Success, New York, 10042

    Recruiting

  • START Los Angeles

    Los Angeles, California, 90025

    Recruiting

  • UW Health Carbone Cancer Center

    Madison, Wisconsin, 53792

    Recruiting

  • Miami Cancer Institute

    Miami, Florida, 33176

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Recruiting

  • START San Antonio (STSA)

    San Antonio, Texas, 78229

    Recruiting

  • START Mountain Region

    West Valley City, Utah, 84119

    Recruiting

Other trials in United States

Japan3 sites, 3 recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo

    Recruiting

Other trials in Japan

About this study

Official title: A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types

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.

Read more

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.

Being tested
ASP546C
Keywords
Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma, Pancreatic Adenocarcinoma, Cholangiocarcinoma, Colorectal adenocarcinoma, Non-small cell lung cancer (NSCLC) (adenocarcinoma), Small cell lung cancer (SCLC), Ovarian mucinous carcinoma, Invasive breast cancer, ASP546C, Claudin 18.2
Medical subject headings
Adenocarcinoma, Cholangiocarcinoma, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP546CDrug

    Also called XNW27011

    Intravenous administration

Study groups in NCT07488676
Study groupRoleWhat they receive
Part 1 - Cohort 1 ASP546C Lower DoseExperimentalParticipants with unresectable locally advanced or metastatic (uLA/m) gastroesophageal adenocarcinoma will receive a lower dose of ASP546C intravenously, once every 3 weeks (Q3W).
Receives: Drug: ASP546C
Part 1 - Cohort 2 ASP546C Higher DoseExperimentalParticipants with uLA/m gastroesophageal adenocarcinoma will receive a higher dose of ASP546C intravenously, once Q3W.
Receives: Drug: ASP546C
Part 2 - Cohort 3 ASP546C Higher DoseExperimentalParticipants with uLA/m pancreatic adenocarcinoma will receive a higher dose of ASP546C intravenously, once Q3W.
Receives: Drug: ASP546C
Part 2 - Cohort 4 ASP546C Higher DoseExperimentalParticipants 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.
Receives: Drug: ASP546C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 36 Months

  2. 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.

    Measured: Up to 39 Months

  3. Part 1: PK of ASP546C ADC: Maximum Concentration (Cmax)

    Cmax will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  4. 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.

    Measured: Up to 39 Months

  5. 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.

    Measured: Up to 39 Months

  6. Part 1: Number of Participants with Vital Sign Abnormalities and/or AEs

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to 39 Months

  7. Part 1: Number of Participants with Laboratory Value Abnormalities and/or AEs

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to 39 Months

  8. 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.

    Measured: Up to 39 Months

Secondary outcomes (32)

  1. 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.

    Measured: Up to 36 Months

  2. 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.

    Measured: Up to 36 Months

  3. 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.

    Measured: Up to 36 Months

  4. 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.

    Measured: Up to 39 Months

  5. 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

    Measured: Up to 39 Months

  6. 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.

    Measured: Up to 39 Months

  7. Part 2: Number of Participants with Vital Sign Abnormalities and/or AEs

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to 39 Months

  8. Part 2: Number of Participants with Laboratory Value Abnormalities and/or AEs

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to 39 Months

  9. 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.

    Measured: Up to 39 Months

  10. 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.

    Measured: Baseline and up to Day 58

  11. 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.

    Measured: Up to 39 Months

  12. Part 1 and Part 2: PK of ASP546C Unconjugated Payload: CEOI

    CEOI will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  13. Part 1 and Part 2: PK of ASP546C Total Antibody: CEOI

    CEOI will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  14. Part 2: PK of ASP546C ADC: AUC0-21d

    AUC0-21d will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  15. Part 1 and Part 2: PK of ASP546C Unconjugated Payload: AUC0-21d

    AUC0-21d will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  16. Part 1 and Part 2: PK of ASP546C Total Antibody: AUC0-21d

    AUC0-21d will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  17. 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.

    Measured: Up to 39 Months

  18. 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.

    Measured: Up to 39 Months

  19. 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.

    Measured: Up to 39 Months

  20. Part 1 and Part 2: PK of ASP546C ADC: Time of Maximum Concentration (tmax)

    tmax will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  21. Part 1 and Part 2: PK of ASP546C Unconjugated Payload: tmax

    tmax will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  22. Part 1 and Part 2: PK of ASP546C Total Antibody: tmax

    tmax will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  23. 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.

    Measured: Up to 39 Months

  24. Part 1 and Part 2: PK of ASP546C Unconjugated Payload: t1/2

    t1/2 will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  25. Part 1 and Part 2: PK of ASP546C Total Antibody: t1/2

    t1/2 will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  26. Part 1 and Part 2: PK of ASP546C ADC: Clearance (CL)

    CL will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  27. Part 1 and Part 2: PK of ASP546C Unconjugated Payload: CL

    CL will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  28. Part 1 and Part 2: PK of ASP546C Total Antibody: CL

    CL will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  29. 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.

    Measured: Up to 39 Months

  30. Part 1 and Part 2: PK of ASP546C Unconjugated Payload: Vss

    Vss will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  31. Part 1 and Part 2: PK of ASP546C Total Antibody: Vss

    Vss will be recorded from the PK serum samples collected.

    Measured: Up to 39 Months

  32. 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.

    Measured: Up to 22 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study start4 May 2026
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07488676
Sponsor's protocol ID
546C-CL-0201
Status last verified
Sep 2026
First submitted
18 Mar 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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/.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ASP546C in people with Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma and Pancreatic Adenocarcinoma, run by Astellas Pharma Global Development, Inc. at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Astellas Pharma Global Development, Inc (800-888-7704, Astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Objective Response Rate (ORR) per Investigator-assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to 36 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07488676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in