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

Recruiting now · Phase 1

Conditions studied: Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastric Squamous Cell Carcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma, Metastatic Solid Tumor, Non-Small Cell Lung Carcinoma, Esophageal Adenocarcinoma, SMARCA4 Mutation, Gastroesophageal Junction Squamous Cell Carcinoma, Advanced Solid Tumor

In brief

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.

Key facts

Study ID
NCT07284186
Run by
Plexium, Inc.
People needed
155
Starts
2025-12-01
Expected to finish
2030-09-01
Last updated by the study team
2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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