Testing BDC-4182 for 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

This study is testing a new drug called BDC-4182 to see if it's safe and how well it works for people with advanced gastric and gastroesophageal cancer.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bolt Biotherapeutics, Inc. (industry)
• Locations: 16 sites (Darlinghurst, New South Wales and 15 other locations)
• Trial ID: NCT06921837 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with metastatic or unresectable gastric or gastroesophageal cancer who have received prior standard therapies or are intolerant to them.

Not a fit: Patients with known central nervous system metastases or those without measurable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced gastric and gastroesophageal cancers.

How similar studies have performed: While this approach is novel, other studies targeting similar cancers have shown promise, indicating potential for success.

Eligibility criteria

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 this trial is running

Darlinghurst, New South Wales and 15 other locations

• 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)
• 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)

Study contacts

• Study coordinator: Bolt Biotherapeutics

Conditions: Gastric Cancer Adenocarcinoma Metastatic, Gastroesophageal Adenocarcinoma, Gastric Cancer, Gastroesophageal Cancer