Actively Recruiting
A Phase 1b/2 Open-label Study Assessing Safety and Efficacy of ASP546C in Adults With CLDN18.2-expressing Advanced Gastroesophageal, Pancreatic, or Other Solid Tumors
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-06-04
150
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ASP546C to find the best dose for adults with advanced cancers including gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors. This trial focuses on tumors that express the CLDN18.2 protein and includes participants with locally advanced unresectable or metastatic disease. The study is sponsored by Astellas Pharma Global Development, Inc. and aims to evaluate safety, dosing, and initial effectiveness of ASP546C. The study has two parts. In Part 1, participants with gastric or GEJ cancer receive either a higher or lower dose of ASP546C through an intravenous infusion every three weeks. In Part 2, participants with pancreatic cancer or other solid tumors receive the higher dose of ASP546C via infusion every three weeks. The study drugs are given slowly through a vein, and dosing schedules are consistent across both parts. Participants will visit the clinic regularly for infusions and health checks, with the number and type of visits tailored to each person's health and treatment status. Researchers will monitor the participants' tumor response using imaging criteria, safety through adverse event reporting, and drug levels in the blood over up to 39 months. They will also assess physical function and collect biomarker data. The study includes long-term follow-up for response and safety while participants receive treatment.
CONDITIONS
Brief 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...
- Diagnosed with gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, or specific other solid tumors expressing CLDN18.2
- Have locally advanced unresectable or metastatic disease confirmed by imaging within 28 days before study start
- Measurable disease for cohorts 1 to 3 or evaluable disease for cohort 4 according to RECIST v1.1
- Received at least one prior therapy for advanced disease
- ECOG performance status of 0 or 1
- Predicted life expectancy of at least 12 weeks
- Female participants must not be pregnant, breastfeeding, or donating eggs and follow contraceptive guidance as required
- Male participants must agree to use contraception or abstain as specified
- Meet laboratory test criteria within 14 days before study start
- Willing to provide tumor tissue for biomarker testing
- Agree not to participate in another interventional study during this trial
You will not qualify if you...
- Disease with non-adenocarcinoma or mixed histology for cohorts 1, 2, and 3
- More than two prior lines of therapy for advanced disease in cohorts 1, 2, and 3
- Complete or partial gastric outlet syndrome with persistent vomiting
- Significant gastric bleeding or untreated peptic ulcer within 3 months before study
- Significant bleeding disorders or vasculitis within 3 months before study
- History of gastrointestinal perforation or fistula within 6 months
- Untreated symptomatic brain metastases or meningeal carcinomatosis
- Difficult-to-control mental illness
- Unresolved or recent pneumonitis requiring steroids
- Positive HIV or active hepatitis B or C infection as defined
- Active infection requiring systemic therapy not resolved within 7 days
- Recent or ongoing other malignancies requiring treatment within 5 years
- Clinically significant fluid buildup requiring frequent drainage
- Unresolved adverse events from prior cancer treatments except hair loss
- Active autoimmune disease needing high dose steroids
- Peripheral neuropathy greater than grade 1 except specific conditions
- Sinusoidal obstruction syndrome not stable or improving
- Significant cardiovascular disease or arrhythmias within 6 months
- Ongoing or prior interstitial lung disease, active diverticulitis, or organ transplant
- Serious non-healing wounds or fractures within 28 days
- Recent 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
- Received live vaccines within 30 days
- Known hypersensitivity to ASP546C or its components
- Any significant disease or condition that could affect safety or study participation
- Known HER2 positive status for cohorts 1 and 2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 39 months
Participants receive intravenous ASP546C once every 3 weeks at either a lower or higher dose depending on their cohort.
Infusions every 3 weeks
Trial Site Locations
Total: 9 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
Duke Cancer Center Durham
Durham, North Carolina, United States, 27710
Actively Recruiting
5
Next Oncology - Austin
Austin, Texas, United States, 78758
Actively Recruiting
6
Next Oncology - Houston
Houston, Texas, United States, 77054
Actively Recruiting
7
Next Oncology - Dallas
Irving, Texas, United States, 75039
Actively Recruiting
8
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
9
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc
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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