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A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-4182 as a Single Agent in Patients With Advanced Gastric and Gastroesophageal Cancer
Led by Bolt Biotherapeutics, Inc. · Updated on 2026-01-27
122
Participants Needed
16
Research Sites
104 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating BDC-4182, an immune stimulating antibody conjugate, in people with advanced gastric and gastroesophageal cancers. This first-in-human dose escalation study aims to assess the safety and tolerability of BDC-4182 and to find the recommended dose for Phase 2. Participants have cancers that are metastatic or unresectable and have usually undergone prior standard treatments or are intolerant to them. Participants receive escalating doses of BDC-4182 until the maximum tolerated dose is found. Additional participants may join backfill cohorts at cleared dose levels to collect more safety data, followed by an expansion phase at the recommended dose. BDC-4182 consists of an anti-claudin 18.2 monoclonal antibody linked to a TLR 7/8 dual agonist, given as a single agent. During the study, participants have safety assessments including adverse event monitoring for about two years, with dose-limiting toxicities evaluated within 21 days of treatment. Effectiveness measures like tumor response rates, duration of response, disease control, progression-free and overall survival, and pharmacokinetics of the drug are tracked for up to four years. Biopsies or archival tumor samples are collected, and organ function is monitored. Participation lasts through dose escalation and expansion phases with ongoing safety and outcome evaluations.
CONDITIONS
Brief 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...
- Measurable disease by RECIST v1.1 criteria
- Histologically or cytologically confirmed metastatic (Stage 4) or unresectable (Stage 3) gastric or gastroesophageal cancer
- Received at least 1-2 prior lines of standard therapies or intolerant to standard treatments
- For escalation participants with known Claudin 18 IHC expression, must have positive expression or at least 1% tumor cells IHC 2+ or higher
- Adequate organ function
- Agree to biopsy before enrollment or submit 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 treatments
- Use of investigational agents or standard anti-cancer therapies within 28 days or 5 elimination half-lives before study start
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.
Duration - Up to approximately 4 years
Participants receive escalating doses of BDC-4182 to evaluate safety and determine the recommended Phase 2 dose, followed by treatment at the selected dose level.
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
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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