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

NCT07284186 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2026-04-13

No results posted yet for this study

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). 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.

Conditions

  • 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

Interventions

DRUG

PLX-61639

Orally available degrader of SMARCA2

Sponsors & Collaborators

  • Plexium, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Plexium, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2029-12-31
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07284186 on ClinicalTrials.gov