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Study identifier: NCT06921837 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Recruiting

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

Condition: Gastric Cancer Adenocarcinoma Metastatic · Gastroesophageal Adenocarcinoma  ·  Sponsor: Bolt Biotherapeutics, Inc.

PhasePhase 1/Phase 2
Planned participants122
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where16 locations · 3 countries

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Bolt Biotherapeutics  ·  +1 650 434 8640  ·  clinicaltrials@boltbio.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (16)

AUS Site 2Darlinghurst, New South Wales, AustraliaRecruiting
AUS Site 5Westmead, New South Wales, AustraliaRecruiting
AUS Site 1Birtinya, Queensland, AustraliaRecruiting
AUS Site 4Clayton, Victoria, AustraliaRecruiting
AUS Site 3Heidelberg, Victoria, AustraliaRecruiting
SK Site 2003Seongnam-si, South KoreaRecruiting
SK Site 2001Seoul, South KoreaRecruiting
SK Site 2002Seoul, South KoreaRecruiting
SK Site 2004Seoul, South KoreaRecruiting
SK Site 2005Seoul, South KoreaRecruiting
TWN Site 9004Kaohsiung City, TaiwanRecruiting
TWN Site 9005Kaohsiung City, TaiwanRecruiting

+ 4 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

DarlinghurstWestmeadBirtinyaClayton

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