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

a study on Squamous Cell Carcinoma Gastric Adenocarcinoma Stomach Cancer Gastroesophageal Junction Cancer Solid Tumor Lung Cancer Non-Small Cell Lung Cancer Esophageal Cancer SMARCA4 Mutation

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Miguel Villalona (uci)
Headshot of Miguel Villalona
Miguel Villalona

Description

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.

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

Keywords

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, Adenocarcinoma, Neoplasm Metastasis, Non-Small-Cell Lung Carcinoma, Adenocarcinoma Of Esophagus, PLX-61639

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Research Site accepting new patients
    Orange California 92868 United States
  • Research Site accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Miguel Villalona (uci)
    Division Chief Hematology & Oncology University of California Irvine Deputy Director, Chao Family Comprehensive Cancer Center Dr. Villalona-Calero received his medical degree (magna cum laude) from Universidad Nacional Pedro Henríquez Ureña, Dominican Republic. He completed residency in internal medicine at State University of New York Health Science Center at Brooklyn.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Plexium, Inc.
ID
NCT07284186
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 155 study participants
Last Updated
Contact us about this trial