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Recruiting NCT07284186

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

Phase I Interventional Esophageal Squamous Cell Carcinoma Gastric Adenocarcinoma Gastric Squamous Cell Carcinoma Gastroesophageal Junction (GEJ) Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PLX-61639.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastric Squamous Cell Carcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug PLX-61639
    Orally available degrader of SMARCA2

Primary outcome measures

  • Treatment Emergent Adverse Events [Time frame: From enrollment to 28 days after the last dose of PLX-61639]
  • Dose-Limiting Toxicities [Time frame: From enrollment to 28 days after first dose of PLX-61639]
Secondary outcome measures (9)
  • Dose reductions due to Adverse Events [Time frame: From Day 1 to the end of PLX-61639 treatment, an average of 1 year]
  • Study treatment discontinuations for reasons other than disease progression [Time frame: From Day 1 to the end of PLX-61639 treatment, an average of 1 year]
  • Pharmacokinetics of PLX-61639: Cmax [Time frame: From Day 1 to Day 15 of Cycle 1 (Part 1 only) (each cycle is 28 days)]
  • Pharmacokinetics of PLX-61639: Tmax [Time frame: From Day 1 to Day 15 of Cycle 1 (Part 1 only) (each cycle is 28 days)]
  • Pharmacokinetics of PLX-61639: AUC0-last [Time frame: From Day 1 to Day 16 of Cycle 1 (Part 1 only) (each cycle is 28 days)]
  • Radiographic response to PLX-61639 [Time frame: From Day 1 to the end of PLX-61639 treatment, an average of 1 year]
  • Time to response (TTR) to PLX-61639 [Time frame: From Day 1 to achievement of partial or complete response, up to 24 weeks]
  • Duration of response (DoR) to PLX-61639 [Time frame: From first documented partial or complete response to disease progression or death, an average of 1 year]
  • Progression Free Survival (PFS) of PLX-61639 [Time frame: From Day 1 to disease progression or death, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Participants with locally advanced or metastatic, relapsed/refractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies
  • Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function
  • Measurable disease per RECIST 1.1
  • ECOG PS of 0 or 1

Exclusion criteria

  • Germline SMARCA4 mutations
  • Known SMARCA2 mutation or loss of expression
  • Symptomatic CNS disease
  • Prior treatment with another SMARCA2-directed therapy
  • History of other malignancies
  • Clinically significant heart disease
  • Uncontrolled hypertension
  • Prolongation of QT interval

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • Research Site — Scottsdale
  • Research Site — Duarte
  • Research Site — Orange
  • Research Site — Boston
  • Research Site — St Louis
  • Research Site — New York
  • Research Site — Durham
  • Research Site — Cleveland
  • … and 2 more centers

Identifiers

NCT: NCT07284186 · PLX-61639-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗