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SMARCA2 Degrader
PRT7732 for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by Prelude Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures
* Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy with any mutation of SMARCA4 by local testing that has either progressed on or is ineligible for standard of care therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion, an average of 2 years
Awards & highlights
Summary
This is a Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation.
Who is the study for?
This trial is for people with advanced or metastatic solid tumors that have a specific genetic change called a SMARCA4 mutation. It's open to those who meet certain health conditions and haven't had success with other treatments.
What is being tested?
The study is testing PRT7732, an oral medication designed to target the SMARCA2 protein in patients. This early-phase trial will assess how safe it is, what doses are tolerable, how the body processes it, and if it works against cancer.
What are the potential side effects?
As this is an early-stage trial for PRT7732, potential side effects aren't fully known yet but may include typical reactions seen with cancer treatments such as nausea, fatigue, and possible liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion, an average of 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Limiting toxicity (DLT) of PRT7732
Maximum tolerated dose (MTD) of PRT7732
Recommended dose for expansion (RDE) of PRT7732
+3 moreSecondary study objectives
Efficacy of PRT7732
Pharmacodynamic effects of PRT7732 as a single agent
Pharmacokinetic profile of PRT7732 as a single agent: Area under the curve
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PRT7732Experimental Treatment1 Intervention
PRT7732 is administered as an oral capsule once daily. Dose escalation/de-escalation decisions will be guided by the BLRM method until the RDE is determined.
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Who is running the clinical trial?
Prelude TherapeuticsLead Sponsor
9 Previous Clinical Trials
655 Total Patients Enrolled
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