Share

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.

info
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.

info
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)
  • info
    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

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT06560645

    Intervention or treatment

    DRUG: PRT7732

    Conditions

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

    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

    Loading...

    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Dose Limiting toxicity (DLT) of PRT7732Incidence of dose limiting toxicities for patients in the dose escalation phaseBaseline through Day 21
    Safety and tolerability of PRT7732 as measured by incidence of DLTsSafety and tolerability will be evaluated by incidence of DLTsBaseline through completion of study, an average of 2 years
    Safety and tolerability of PRT7732 as measured by incidence of laboratory deviationsSafety and tolerability will be evaluated by laboratory measurementsBaseline through study completion, an average of 2 years
    Safety and tolerability as measured by rates of dose modification due to AEs according to NCI CTCAESafety 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 PRT7732Maximum 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 dataBaseline through study completion, an average of 2 years
    Recommended dose for expansion (RDE) of PRT7732The 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 dataBaseline through study completion, an average of 2 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Efficacy of PRT7732Best overall response of either complete response (CR) or partial response (PR), as assessed by the investigator per RECIST v1.1Baseline through study completion, an average of 2 years
    Pharmacokinetic profile of PRT7732 as a single agent: Maximum observed plasma concentrationPharmacokinetics will be calculated including the maximum observed plasma concentrationBaseline through study completion, an average of 2 years
    Pharmacokinetic profile of PRT7732 as a single agent: Area under the curvePharmacokinetics 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 techniquesBaseline through study completion, an average of 2 years
    Pharmacodynamic effects of PRT7732 as a single agentThe 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 tissueBaseline 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

    Other trails to consider

    Top searched conditions