Actively Recruiting
A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-04-15
150
Participants Needed
8
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of gastroesophageal (gastric/GEJ/esophageal) adenocarcinoma, pancreatic adenocarcinoma, or specified other solid tumors
- Radiologically confirmed locally advanced or metastatic disease within 28 days before first dose
- Measurable disease per RECIST v1.1 for cohorts 1-3; evaluable disease for cohort 4
- Tumor expresses CLDN18.2
- Received at least 1 line of therapy for advanced disease
- ECOG performance status 0 or 1
- Predicted life expectancy of 12 weeks or more
- Female participants not pregnant and agree to contraception as specified
- Female participants not breastfeeding or donating ova during study and specified period after
- Male participants agree to contraception or abstinence during study and specified period after
- Meet laboratory test criteria within 14 days prior to first dose
- Willing to provide or have sufficient tumor tissue for biomarker assessment
- Agree not to participate in another interventional study during this study
You will not qualify if you...
- Non-adenocarcinoma or mixed histology for cohorts 1-3
- More than 2 prior lines of therapy for advanced disease for cohorts 1-3
- Complete or partial gastric outlet syndrome with persistent vomiting
- Significant gastric bleeding or untreated peptic ulcer disease within 3 months
- Significant bleeding disorders or vasculitis within 3 months
- History of gastrointestinal perforation or fistula within 6 months
- Symptomatic untreated brain metastases or meningeal carcinomatosis
- Uncontrolled mental illness
- Unresolved or recent pneumonitis requiring steroids
- Known HIV infection or active hepatitis B or C infection as specified
- Active infection requiring systemic therapy unresolved within 7 days
- Other malignancies requiring treatment or with recent history within 5 years
- Clinically significant third spacing requiring drainage
- Unresolved adverse events from prior treatments except alopecia
- Active autoimmune disease requiring high dose steroids
- Peripheral neuropathy greater than grade 1 except certain exceptions
- Sinusoidal obstruction syndrome not stable or improving
- Significant cardiovascular disease including recent events or arrhythmias
- Ongoing or previous interstitial lung disease, active diverticulitis, or organ transplant
- Serious non-healing wounds or fractures within 28 days
- Major surgery within 28 days without full recovery
- Recent chemotherapy, immunotherapy, or investigational therapy within 14 days without recovery
- Prior treatment with CLDN18.2 antibody-drug conjugate
- Live or live-attenuated vaccine within 30 days
- Known hypersensitivity to ASP546C or its components
- Other clinically significant diseases or conditions making participation unsafe
- Known HER2 positive status for cohorts 1 and 2
AI-Screening
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Trial Site Locations
Total: 8 locations
1
START Los Angeles
Los Angeles, California, United States, 90025
Actively Recruiting
2
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
START New York
Lake Success, New York, United States, 10042
Actively Recruiting
4
Next Oncology - Austin
Austin, Texas, United States, 78758
Actively Recruiting
5
Next Oncology - Houston
Houston, Texas, United States, 77054
Actively Recruiting
6
Next Oncology - Dallas
Irving, Texas, United States, 75039
Actively Recruiting
7
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
8
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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