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NCT07284186 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by Plexium.

Recruiting
Registry status
Phase 1
Development phase
155
Enrollment target
10
Study locations

NCT07284186 is a Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor that is actively recruiting participants, run by Plexium. The registered enrollment target is 155 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (19% lower). The trial reports 10 study locations across 9 states.

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The verdict

NCT07284186, a Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, is actively recruiting participants, sponsored by Plexium.

RECRUITING
Registry status
Phase 1
Development phase
155 participants
Enrollment target
10
Study locations

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 Studied

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

Interventions

  • DRUG PLX-61639

Study Locations (10)

California

  • Research Site - Duarte
  • Research Site - Orange

Arizona

  • Research Site - Scottsdale

Massachusetts

  • Research Site - Boston

Missouri

  • Research Site - St Louis

New York

  • Research Site - New York

North Carolina

  • Research Site - Durham

Ohio

  • Research Site - Cleveland

Texas

  • Research Site - San Antonio

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2025-12-01
Est. Completion 2030-09
Phase Phase 1

Sponsor

Plexium

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07284186

The ClinicalTrials.gov registry entry for NCT07284186 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (19% lower). The listed sponsor is Plexium, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which PLX-61639 is the first listed.

NCT07284186 reports 10 study locations spanning 9 distinct geographic areas - top geographies include California, Arizona, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT07284186 about?

NCT07284186 is a clinical study titled "First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors". 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, approv...

What is the current status of trial NCT07284186?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 155 participants. The study started on 2025-12-01. Estimated completion is 2030-09.

What conditions does trial NCT07284186 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Metastatic Solid Tumor, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Non-Small-Cell Lung Carcinoma.

What interventions are being tested in trial NCT07284186?

The interventions under investigation include: PLX-61639 (DRUG).

Who is sponsoring clinical trial NCT07284186?

This trial is sponsored by Plexium, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07284186 being conducted?

This trial has 10 study locations across Arizona, California, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.