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RecruitingLast updated: 19 May 2026

BBI-4182-101: A study recruiting people with advanced gastric and gastroesophageal cancer to evaluate the effectiveness of a new drug called BDC-4182.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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

BBI-4182-101

Clinical summary

Summary

This study is designed to evaluate the safety and tolerability of BDC-4182 to establish the recommended Phase 2 dose (RP2D) for the treatment of advanced gastric and gastroesophageal cancer. First, eligible participants will be given BDC-4182 in increasing doses. This will help determine the highest safe dose. The study will then expand to evaluate this safe dose. 

To be eligible, you must not have 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.

Conditions

This trial is treating people with advanced gastric and gastroesophageal cancer.

Eligibility

Inclusion

  • 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.

Exclusion

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Bolt Biotherapeutics, Inc.

Scientific Title

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

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