Save

A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation

PHASE1RECRUITING

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.

Simpliy with AI

Study details:

This is an open-label, multi-center, first-in-human, Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 an oral SMARCA degrader in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation. Approximately 104 participants will be enrolled.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Must have measurable or non-measurable (but evaluable) disease per RECIST v1.1

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

Willing to provide either archival or fresh tumor tissue sample

Adequate organ function (hematology, renal, and hepatic)

Exclusion criteria

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

History of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study

Receipt of any targeted therapy directed against BRM/BRG1 (SMARCA2/SMARCA4)

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-11-04

Primary completion: 2026-10-01

Study completion finish: 2027-04-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06560645

Intervention or treatment

DRUG: PRT7732

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Non-small Cell Lung Carcinoma
• SMARCA4 Mutation

Condition: Advanced Solid Tumor, Metastatic Solid Tumor and more
DRUG: PRT7732
Randwick, New South Wales, Australia and more
Sponsor: Prelude Therapeutics

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Scientia Clinical Research Ltd

Research sites nearby

Select from list below to view details:

Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Southern Highlands Cancer Centre
Bowral, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: PRT7732 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.	DRUG: PRT7732 PRT7732 capsules will be self-administered once daily at the dose-level assigned

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Dose Limiting toxicity (DLT) of PRT7732	Incidence of dose limiting toxicities for patients in the dose escalation phase	Baseline through Day 21
Safety and tolerability of PRT7732 as measured by incidence of DLTs	Safety and tolerability will be evaluated by incidence of DLTs	Baseline through completion of study, an average of 2 years
Safety and tolerability of PRT7732 as measured by incidence of laboratory deviations	Safety and tolerability will be evaluated by laboratory measurements	Baseline through study completion, an average of 2 years
Safety and tolerability as measured by rates of dose modification due to AEs according to NCI CTCAE	Safety and tolerability will be evaluated by dose interruption, modification, and discontinuation due to adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)	Baseline through study completion, an average of 2 years
Maximum tolerated dose (MTD) of PRT7732	Maximum tolerated dose will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data	Baseline through study completion, an average of 2 years
Recommended dose for expansion (RDE) of PRT7732	The RDE will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data	Baseline through study completion, an average of 2 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Efficacy of PRT7732	Best overall response of either complete response (CR) or partial response (PR), as assessed by the investigator per RECIST v1.1	Baseline through study completion, an average of 2 years
Pharmacokinetic profile of PRT7732 as a single agent: Maximum observed plasma concentration	Pharmacokinetics will be calculated including the maximum observed plasma concentration	Baseline through study completion, an average of 2 years
Pharmacokinetic profile of PRT7732 as a single agent: Area under the curve	Pharmacokinetics will be calculated including the area under the plasma concentration versus time curve (AUC)	Baseline through study completion, an average of 2 years
Pharmacokinetic profile of PRT7732 as a single agent: Time of maximum concentration (Tmax) and half-life (T1/2)	Pharmacokinetic parameters will be calculated using standard non-compartmental techniques	Baseline through study completion, an average of 2 years
Pharmacodynamic effects of PRT7732 as a single agent	The pharmacodynamic effect of PRT7732 demonstrating target engagement by assessment of SMARCA2 protein in peripheral blood mononuclear cells and tumor tissue as assessed by reduction in protein levels of SMARCA2 in peripheral blood mononuclear cells and/or tumor tissue	Baseline through study completion, an average of 2 years

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation