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OncoMatch/Clinical Trials/NCT07284186

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

Is NCT07284186 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PLX-61639 for esophageal squamous cell carcinoma.

Phase 1RecruitingPlexium, Inc.NCT07284186Data as of May 2026

Treatment: PLX-61639 — 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 treatment by the Investigator or participant.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Gastric Cancer

Tumor Agnostic

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: SMARCA4 loss-of-function mutation

Excluded: SMARCA2 loss of expression

Excluded: SMARCA2 mutation

Excluded: SMARCA4 germline mutation

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: smarca2-directed therapy

Lab requirements

Blood counts

adequate bone marrow function

Kidney function

adequate renal function

Liver function

adequate liver function

Cardiac function

adequate cardiopulmonary function

Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Research Site · Scottsdale, Arizona
  • Research Site · Duarte, California
  • Research Site · Orange, California
  • Research Site · Boston, Massachusetts
  • Research Site · St Louis, Missouri

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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