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A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
Led by Bolt Biotherapeutics, Inc. · Updated on 2026-01-27
122
Participants Needed
16
Research Sites
205 weeks
Total Duration
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AI-Summary
What this Trial Is About
A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers
CONDITIONS
Official Title
A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have measurable disease by RECIST v1.1 criteria
- Histologically or cytologically confirmed metastatic (Stage 4) or unresectable (Stage 3) gastric or gastroesophageal cancer
- Have received at least 1-2 prior lines of standard therapies or be intolerant to standard therapies
- For dose escalation: if Claudin 18 expression is known, must be positive or have expression ≥ 1% of tumor cells with IHC ≥ 2+
- Have adequate organ function
- Agree to biopsy before enrollment or provide an adequate archival tumor sample if biopsy is not feasible
You will not qualify if you...
- Known central nervous system metastases unless asymptomatic, stable, and off steroids for at least 14 days
- Cardiac, pulmonary, or hepatic disease
- Active infection
- History of inflammatory eye disease
- Residual toxicity from previous treatment
- Use of investigational agents or standard anti-cancer therapies within 28 days or 5 elimination half-lives before starting study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
AUS Site 2
Darlinghurst, New South Wales, Australia
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2
AUS Site 5
Westmead, New South Wales, Australia
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3
AUS Site 1
Birtinya, Queensland, Australia
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4
AUS Site 4
Clayton, Victoria, Australia
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5
AUS Site 3
Heidelberg, Victoria, Australia
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6
SK Site 2003
Seongnam-si, South Korea
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7
SK Site 2001
Seoul, South Korea
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8
SK Site 2002
Seoul, South Korea
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9
SK Site 2004
Seoul, South Korea
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10
SK Site 2005
Seoul, South Korea
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11
TWN Site 9004
Kaohsiung City, Taiwan
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12
TWN Site 9005
Kaohsiung City, Taiwan
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13
TWN Site 9001
Taichung, Taiwan
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14
TWN Site 9003
Taipei, Taiwan
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15
TWN Site 9006
Taipei, Taiwan
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16
TWN Site 9002
Taoyuan, Taiwan
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Research Team
B
Bolt Biotherapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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