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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllBolt Biotherapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 1% of tumor cells IHC โ‰ฅ 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.
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What it tests

  • BDC-4182
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Where

16 sites
AUS Site 2
Darlinghurst, Australia
AUS Site 5
Westmead, Australia
AUS Site 1
Birtinya, Australia
AUS Site 4
Clayton, Australia
AUS Site 3
Heidelberg, Australia
SK Site 2003
Seongnam-si, South Korea
SK Site 2001
Seoul, South Korea
SK Site 2002
Seoul, South Korea

โ€ฆand 8 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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