First-in-Human Study of PLX-61639 for Advanced Solid Tumors

This study is testing a new oral medicine called PLX-61639 for people with locally advanced or metastatic (spread to other parts of the body) solid tumors. These tumors must have a specific genetic change called a SMARCA4 loss-of-function mutation and have not responded to or cannot receive other approved treatments. The main goals are to understand the safety of PLX-61639 and how the body handles it, as well as to see if it shows any early signs of shrinking tumors. You would be eligible if you are 18 or older, have measurable disease, and good organ function. This is a "first-in-human" study, meaning it's the first time this drug is being tested in people.

Study design
This is a single-arm study, meaning all participants receive the same treatment, and it is the first time this drug is being tested in humans. It plans to enroll 155 participants and has three parts: finding the right dose, optimizing the dose, and expanding the study.
What's involved
You would first go through a screening period of up to 28 days to see if you qualify. If eligible, you would then receive treatment in 28-day cycles, followed by an end-of-treatment visit and a post-treatment follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed after their last dose of PLX-61639, with safety monitored for 28 days after the last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07284186

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Plexium, Inc.
~155 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:PLX-61639

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Emergent Adverse Events
Measured over From enrollment to 28 days after the last dose of PLX-61639
+1 more outcome measured
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
10 sites across 9 states
California2
Arizona1
Massachusetts1
Missouri1
New York1
North Carolina1
Ohio1
Texas1
  • Chief Medical Officer · STUDY_DIRECTOR · Plexium, Inc.

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Eligibility criteria

Inclusion

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

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
  • Treatment Emergent Adverse EventsFrom enrollment to 28 days after the last dose of PLX-61639
  • Dose-Limiting ToxicitiesFrom enrollment to 28 days after first dose of PLX-61639