First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT07284186. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07284186
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 155 participants
Conditions and interventions
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
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2025
- Primary completion
- Nov 30, 2029
- Completion
- Aug 31, 2030
- Last update posted
- Jun 11, 2026
2025 – 2030
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Scottsdale | Arizona | 85258 | Recruiting |
| Research Site | Duarte | California | 91010 | Recruiting |
| Research Site | Orange | California | 92868 | Recruiting |
| Research Site | Boston | Massachusetts | 02114 | Recruiting |
| Research Site | St Louis | Missouri | 63110 | Recruiting |
| Research Site | New York | New York | 10044 | Recruiting |
| Research Site | Durham | North Carolina | 27710 | Recruiting |
| Research Site | Cleveland | Ohio | 44106 | Recruiting |
| Research Site | San Antonio | Texas | 78229 | Recruiting |
| Research Site | Fairfax | Virginia | 22031 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07284186, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 11, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07284186 live on ClinicalTrials.gov.