NCT06921837

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Bolt Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a dose escalation study designed to evaluate the safety and tolerability of BDC-4182 to establish the recommended Phase 2 dose (RP2D). Participants will be enrolled in each dose cohort until the maximum tolerated dose (MTD) is reached. Additional participants may be enrolled into backfill cohorts at dose levels that have been cleared to collect additional safety and tolerability data. Additional participants may be enrolled at the determined RP2D in an expansion portion of the study.

Conditions

• Gastric Cancer Adenocarcinoma Metastatic
• Gastroesophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	BDC-4182	Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

Timeline

• Start date: 2025-05-26
• Primary completion: 2027-05-01
• Completion: 2029-05-01
• First posted: 2025-04-10
• Last updated: 2026-01-27

Locations

16 sites across 3 countries: Australia, South Korea, Taiwan

Regulatory

• FDA-regulated drug study