A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors

Study Identifier:
PLX-61639-101
CT.gov Identifier:
NCT07284186
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Esophageal
  • Gastric
  • Gastroesophageal
  • Solid Tumor
  • Non-Small Cell Lung Cancer
  • Gene Mutatations
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: PLX-61639
    • Read More
  • Drug: Drug: PLX-61639
  • Drug: Orally available degrader of SMARCA2
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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
    • Key
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruiting
    Condition(s) Treated at Site
    Esophageal
    Gastric
    Gastroesophageal
    Solid Tumor
    Non-Small Cell Lung Cancer
    Gene Mutatations