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First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllPlexium, Inc.
NCT07284186 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed/refractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies. The study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase. Participants will receive their assigned dose of PLX-61639 administered orally, once daily until progression/relapse, intolerance, death, or withdrawal from study tr

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📋 Eligibility rules (as published)
Key Inclusion Criteria: * Participants with locally advanced or metastatic, relapsed/refractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies * Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function * Measurable disease per RECIST 1.1 * ECOG PS of 0 or 1 Key Exclusion Criteria: * Germline SMARCA4 mutations * Known SMARCA2 mutation or loss of expression * Symptomatic CNS disease * Prior treatment with another SMARCA2-directed therapy * History of other malignancies * Clinically significant heart disease * Uncontrolled hypertension * Prolongation of QT interval
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What it tests

  • PLX-61639
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Where

10 sites
Research Site
Scottsdale, United States
Research Site
Duarte, United States
Research Site
Orange, United States
Research Site
Boston, United States
Research Site
St Louis, United States
Research Site
New York, United States
Research Site
Durham, United States
Research Site
Cleveland, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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