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.
First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
At a glance
Conditions
Where it's being run
10 sites across 9 statesStudy leadership
- Chief Medical Officer · STUDY_DIRECTOR · Plexium, Inc.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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