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SMARCA2 Degrader

PRT7732 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Prelude Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Participants with solid tumors with known concomitant SMARCA2 mutation or loss of protein expression

Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic central nervous system (CNS) metastases or leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called PRT7732 in patients with specific types of advanced or metastatic solid tumors. The main goal is to see if the drug is safe and well-toler

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 below

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My cancer has a SMARCA4 mutation and has worsened or can't be treated with standard care.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My solid tumor has a SMARCA2 mutation or lacks SMARCA2 protein.

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I do not have uncontrolled heart, electrolyte, or severe brain/spinal cord conditions.

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I have received targeted therapy for BRM/BRG1.

Timeline

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, an average of 2 years for reporting.

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 more

Secondary 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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 5Eligibility criteria met