Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06921837

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

On this page

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 16 locations

1

AUS Site 2

Darlinghurst, New South Wales, Australia

Actively Recruiting

2

AUS Site 5

Westmead, New South Wales, Australia

Actively Recruiting

3

AUS Site 1

Birtinya, Queensland, Australia

Actively Recruiting

4

AUS Site 4

Clayton, Victoria, Australia

Actively Recruiting

5

AUS Site 3

Heidelberg, Victoria, Australia

Actively Recruiting

6

SK Site 2003

Seongnam-si, South Korea

Actively Recruiting

7

SK Site 2001

Seoul, South Korea

Actively Recruiting

8

SK Site 2002

Seoul, South Korea

Actively Recruiting

9

SK Site 2004

Seoul, South Korea

Actively Recruiting

10

SK Site 2005

Seoul, South Korea

Actively Recruiting

11

TWN Site 9004

Kaohsiung City, Taiwan

Actively Recruiting

12

TWN Site 9005

Kaohsiung City, Taiwan

Actively Recruiting

13

TWN Site 9001

Taichung, Taiwan

Actively Recruiting

14

TWN Site 9003

Taipei, Taiwan

Actively Recruiting

15

TWN Site 9006

Taipei, Taiwan

Actively Recruiting

16

TWN Site 9002

Taoyuan, Taiwan

Actively Recruiting

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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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A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer | DecenTrialz