Actively Recruiting
First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
Led by Plexium, Inc. · Updated on 2026-04-13
155
Participants Needed
10
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
You will not qualify if you...
- Germline SMARCA4 mutations
- Known SMARCA2 mutation or loss of expression
- Symptomatic central nervous system disease
- Prior treatment with another SMARCA2-directed therapy
- History of other malignancies
- Clinically significant heart disease
- Uncontrolled hypertension
- Prolongation of QT interval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Research Site
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Research Site
Duarte, California, United States, 91010
Not Yet Recruiting
3
Research Site
Orange, California, United States, 92868
Not Yet Recruiting
4
Research Site
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
5
Research Site
St Louis, Missouri, United States, 63110
Actively Recruiting
6
Research Site
New York, New York, United States, 10044
Actively Recruiting
7
Research Site
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Research Site
Cleveland, Ohio, United States, 44106
Actively Recruiting
9
Research Site
San Antonio, Texas, United States, 78229
Actively Recruiting
10
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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