A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
NCT ID: NCT06921837
Last Updated: 2026-01-27
Study Results
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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RECRUITING
PHASE1/PHASE2
122 participants
INTERVENTIONAL
2025-05-26
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Escalating doses followed by backfill of selected doses
BDC-4182
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
BDC-4182
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bolt Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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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
AUS Site 5
Westmead, New South Wales, Australia
AUS Site 1
Birtinya, Queensland, Australia
AUS Site 4
Clayton, Victoria, Australia
AUS Site 3
Heidelberg, Victoria, Australia
SK Site 2003
Seongnam-si, , South Korea
SK Site 2001
Seoul, , South Korea
SK Site 2002
Seoul, , South Korea
SK Site 2004
Seoul, , South Korea
SK Site 2005
Seoul, , South Korea
TWN Site 9004
Kaohsiung City, , Taiwan
TWN Site 9005
Kaohsiung City, , Taiwan
TWN Site 9001
Taichung, , Taiwan
TWN Site 9003
Taipei, , Taiwan
TWN Site 9006
Taipei, , Taiwan
TWN Site 9002
Taoyuan District, , Taiwan
Countries
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Central Contacts
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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
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