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

Summary

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

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

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Plexium, Inc.

Last updated on ClinicalTrials.gov

June 12, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites