Esophageal Squamous Cell Carcinoma study: PLX-61639
Official title First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07284186
What this study is testing
What is PLX-61639?
PLX-61639 is an investigational oral medicine being studied for esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether PLX-61639 is safe and may help shrink tumors in people with SMARCA4‑deficient cancers.
- Who it's for
- You may be able to join if you have a locally advanced or metastatic solid tumor with a SMARCA4 mutation and have tried other approved treatments.
- What's involved
- You will take PLX-61639 by mouth once a day. You will have regular visits for check‑ups and tests to see how you are doing.
- Time commitment
- The study lasts up to about 6 months, with visits every 28 days during treatment and a final follow‑up after stopping the drug.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with locally advanced or metastatic, relapsed/refractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have...
- Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function
- Measurable disease per RECIST 1.1
- ECOG PS of 0 or 1 Key
You likely 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
See the full eligibility criteria
- 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...
- Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function
- Measurable disease per RECIST 1.1
- ECOG PS of 0 or 1 Key
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Duarte, California, United States
- Orange, California, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Duarte, California, United States; Orange, California, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; New York, New York, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.