Share
Save
A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: PRT7732
|
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!