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

Phase 1

Recruiting

• Conditions: Gastric Cancer Adenocarcinoma Metastatic; Gastroesophageal Adenocarcinoma
• Interventions: Drug: BDC-4182

• Registration Number: NCT06921837
• Lead Sponsor: Bolt Biotherapeutics, Inc.

Brief Summary

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

Detailed Description

This is a dose escalation study designed to evaluate the safety and tolerability of BDC-4182 to establish the recommended Phase 2 dose (RP2D). Participants will be enrolled in each dose cohort until the maximum tolerated dose (MTD) is reached. Additional participants may be enrolled into backfill cohorts at dose levels that have been cleared to collect additional safety and tolerability data. Additional participants may be enrolled at the determined RP2D in an expansion portion of the study.

Study Timeline

• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Study First Posted: 2025-04-10
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	BDC-4182	Escalating doses followed by backfill of selected doses
Dose Expansion	BDC-4182	Expansion at determined RP2D

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0	approximately 2 years	Escalation period
Incidence and nature of AEs considered by the Investigator or Sponsor to be clinically relevant, attributable to study treatment, and meeting dose-limiting toxicity (DLT) criteria	Up to 21 days	Escalation period

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR) according to RECIST v. 1.1	approximately 4 years	Escalation and expansion periods
Duration of Response (DOR)	approximately 4 years	Escalation and expansion periods
Disease control rate (DCR)	approximately 4 years	Escalation and expansion periods
Progression-free survival (PFS)	approximately 4 years	Escalation and expansion periods
Best Overall Response (BOR)	approximately 4 years	Escalation and expansion periods
Overall survival (OS)	approximately 4 years	Escalation and expansion periods
PK (Cmax) of BDC-4182	approximately 4 years	Escalation and expansion periods
PK (Cmin) of BDC-4182	approximately 4 years	Escalation and expansion periods
PK (AUC0-tau) of BDC-4182	approximately 4 years	Escalation and expansion periods
PK (AUC0-inf) of BDC-4182	approximately 4 years	Escalation and expansion periods
PK (CL) of BDC-4182	approximately 4 years	Escalation and expansion periods
PK (Vc or Vss) of BDC-4182	approximately 4 years	Escalation and expansion periods
PK (Terminal half-life) of BDC-4182	approximately 4 years	Escalation and expansion periods

Trial Locations

Locations (2)

AUS Site 2; 🇦🇺 Darlinghurst, New South Wales, Australia

AUS Site 1; 🇦🇺 Birtinya, Queensland, Australia