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Clinical Trials in South Korea / NCT06921837
Recruiting Phase 1/2

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

NCT06921837 · tracked via the Priya Life Science South Korea tracker
Sponsor
Bolt Biotherapeutics, Inc
Phase
Phase 1/2
Started
2025-05-26
Last updated
2026-01-27

Condition(s) studied

Gastric Cancer Adenocarcinoma MetastaticGastroesophageal Adenocarcinoma

Investigational drug(s) / intervention(s)

BDC-4182

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. * Subjects must have histologically/cytologically confirmed gastric or gastroesophageal cancer that is metastatic (Stage 4) or unresectable (Stage 3). * Subjects must have received at least 1-2 prior lines of locally available standard therapies or must be intolerant of standard therapies. * For subjects in escalation: If prior Claudin 18 IHC expression is known, the subject must have some degree of Claudin 18 expression as defined as Positive or have expression ≥ 1% of tumor cells IHC ≥ 2+. Consult with Medical Monitor as needed. * Adequate organ function * Agree to have a biopsy prior to enrollment, at acceptable risk in the judgement of the Investigator. If a biopsy is not safely accessible or clinically feasible, an adequate archival tumor sample must be submitted. Key Exclusion Criteria: * Known central nervous system (CNS) metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 14 days before starting study treatment. * Cardiac disease, pulmonary disease, or hepatic disease * Active infection * History of inflammatory eye disease * Residual toxicity from a previous treatment * Any investigational agent or standard anti-cancer therapies within 28 days before starting study treatment or within 5 estimated elimination half-lives, whichever is shorter.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
AUS Site 2 Darlinghurst New South Wales Recruiting
AUS Site 5 Westmead New South Wales Recruiting
AUS Site 1 Birtinya Queensland Recruiting
AUS Site 4 Clayton Victoria Recruiting
AUS Site 3 Heidelberg Victoria Recruiting
SK Site 2003 Seongnam-si South Korea Recruiting
SK Site 2001 Seoul South Korea Recruiting
SK Site 2002 Seoul South Korea Recruiting
SK Site 2004 Seoul South Korea Recruiting
SK Site 2005 Seoul South Korea Recruiting
TWN Site 9004 Kaohsiung City Taiwan Recruiting
TWN Site 9005 Kaohsiung City Taiwan Recruiting
TWN Site 9001 Taichung Taiwan Recruiting
TWN Site 9003 Taipei Taiwan Recruiting
TWN Site 9006 Taipei Taiwan Recruiting
TWN Site 9002 Taoyuan Taiwan Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06921837 on ClinicalTrials.gov ↗ ← All trials in South Korea