Testing BDC-4182 for advanced gastric and gastroesophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, dose escalation study evaluating the safety and tolerability of BDC-4182 as a single agent in patients with advanced gastric and gastroesophageal cancers. Participants will be enrolled in various dose cohorts until the maximum tolerated dose is identified. The study aims to establish the recommended Phase 2 dose (RP2D) and may include additional participants in backfill cohorts to gather more safety data. The study will also involve biopsies to assess Claudin 18 expression in tumors.

Why it matters

Who can join: the full rules

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.

Where it's running

• AUS Site 2
  Darlinghurst, New South Wales, Australia Recruiting
• AUS Site 5
  Westmead, New South Wales, Australia Recruiting
• AUS Site 1
  Birtinya, Queensland, Australia Recruiting
• AUS Site 4
  Clayton, Victoria, Australia Recruiting
• AUS Site 3
  Heidelberg, Victoria, Australia Recruiting
• SK Site 2003
  Seongnam-si, South Korea Recruiting

Study contacts

• Study coordinator: Bolt Biotherapeutics
• Email: clinicaltrials@boltbio.com
• Phone: +1 650 434 8640

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.