Status:
RECRUITING
A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
Lead Sponsor:
Bolt Biotherapeutics, Inc.
Conditions:
Gastric Cancer Adenocarcinoma Metastatic
Gastroesophageal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 t...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06921837
Start Date
May 26 2025
End Date
May 1 2029
Last Update
November 12 2025
Active Locations (16)
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1
AUS Site 2
Darlinghurst, New South Wales, Australia
2
AUS Site 5
Westmead, New South Wales, Australia
3
AUS Site 1
Birtinya, Queensland, Australia
4
AUS Site 4
Clayton, Victoria, Australia