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

NCT ID: NCT06921837

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-26

Study Completion Date

2029-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Cancer Adenocarcinoma Metastatic Gastroesophageal Adenocarcinoma

Keywords

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Gastric Cancer Gastroesophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

Escalating doses followed by backfill of selected doses

Group Type EXPERIMENTAL

BDC-4182

Intervention Type DRUG

Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

Dose Expansion

Expansion at determined RP2D

Group Type EXPERIMENTAL

BDC-4182

Intervention Type DRUG

Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

Interventions

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BDC-4182

Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bolt Biotherapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bolt Clinical Development

Role: STUDY_DIRECTOR

Bolt Biotherapeutics

Locations

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AUS Site 2

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

AUS Site 5

Westmead, New South Wales, Australia

Site Status RECRUITING

AUS Site 1

Birtinya, Queensland, Australia

Site Status RECRUITING

AUS Site 4

Clayton, Victoria, Australia

Site Status RECRUITING

AUS Site 3

Heidelberg, Victoria, Australia

Site Status RECRUITING

SK Site 2003

Seongnam-si, , South Korea

Site Status RECRUITING

SK Site 2001

Seoul, , South Korea

Site Status RECRUITING

SK Site 2002

Seoul, , South Korea

Site Status RECRUITING

SK Site 2004

Seoul, , South Korea

Site Status RECRUITING

SK Site 2005

Seoul, , South Korea

Site Status RECRUITING

TWN Site 9004

Kaohsiung City, , Taiwan

Site Status RECRUITING

TWN Site 9005

Kaohsiung City, , Taiwan

Site Status RECRUITING

TWN Site 9001

Taichung, , Taiwan

Site Status RECRUITING

TWN Site 9003

Taipei, , Taiwan

Site Status RECRUITING

TWN Site 9006

Taipei, , Taiwan

Site Status NOT_YET_RECRUITING

TWN Site 9002

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Australia South Korea Taiwan

Central Contacts

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Bolt Biotherapeutics

Role: CONTACT

Phone: +1 650 434 8640

Email: [email protected]

Facility Contacts

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Site 8002

Role: primary

Site 8005

Role: primary

Site 8001

Role: primary

Site 8004

Role: primary

Site 8003

Role: primary

Site 2003

Role: primary

Site 2001

Role: primary

Site 2002

Role: primary

Site 2004

Role: primary

Site 2005

Role: primary

Site 9004

Role: primary

Site 9005

Role: primary

Site 9001

Role: primary

Site 9003

Role: primary

Site 9006

Role: primary

Site 9002

Role: primary

Other Identifiers

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BBI-4182-101

Identifier Type: -

Identifier Source: org_study_id