Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
NCT07284186 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2030-09 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Plexium, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07284186 reports 10 study locations spanning 9 distinct geographic areas — top geographies include California, Arizona, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Esophageal Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07284186?
The interventions under investigation include: PLX-61639 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07284186?
This trial is sponsored by Plexium, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.