RecruitingPhase 1Phase 2NCT06921837

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

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


Sponsor

Bolt Biotherapeutics, Inc.

Enrollment

122 participants

Start Date

May 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new drug called BDC-4182 for people with advanced stomach or gastroesophageal junction (where the stomach meets the esophagus) cancer. The drug targets a protein called Claudin 18.2, which is found on many gastric cancer cells. **You may be eligible if...** - You have confirmed stage 3 (unresectable) or stage 4 (metastatic) gastric or gastroesophageal cancer - You have already tried at least one or two standard treatments, or cannot tolerate them - Your tumor expresses the Claudin 18.2 protein - You have measurable disease on imaging - Your organ function is adequate **You may NOT be eligible if...** - You have never received any prior treatment for your cancer - Your tumor does not express Claudin 18.2 - You have active autoimmune disease, uncontrolled infections, or poor overall health - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBDC-4182

Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist


Locations(16)

AUS Site 2

Darlinghurst, New South Wales, Australia

AUS Site 5

Westmead, New South Wales, Australia

AUS Site 1

Birtinya, Queensland, Australia

AUS Site 4

Clayton, Victoria, Australia

AUS Site 3

Heidelberg, Victoria, Australia

SK Site 2003

Seongnam-si, South Korea

SK Site 2001

Seoul, South Korea

SK Site 2002

Seoul, South Korea

SK Site 2004

Seoul, South Korea

SK Site 2005

Seoul, South Korea

TWN Site 9004

Kaohsiung City, Taiwan

TWN Site 9005

Kaohsiung City, Taiwan

TWN Site 9001

Taichung, Taiwan

TWN Site 9003

Taipei, Taiwan

TWN Site 9006

Taipei, Taiwan

TWN Site 9002

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06921837


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