First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT07284186
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
155 participants
INTERVENTIONAL
2025-12-31
2030-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
In Part 2, participants will be randomized 1:1 to 1 of 2 dose levels at or below the maximally tolerated (or administered) dose evaluated during Part 1.
In Part 3, additional participants will enroll sequentially to 1 dose level selected from Part 2.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PLX-61639
PLX-61639
Orally available degrader of SMARCA2
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PLX-61639
Orally available degrader of SMARCA2
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function
* Measurable disease per RECIST 1.1
* ECOG PS of 0 or 1
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Plexium, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chief Medical Officer
Role: STUDY_DIRECTOR
Plexium, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
San Antonio, Texas, United States
Research Site
Fairfax, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PLX-61639-101
Identifier Type: -
Identifier Source: org_study_id