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Trial Title:
A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
NCT ID:
NCT06560645
Condition:
Advanced Solid Tumor
Metastatic Solid Tumor
Non-small Cell Lung Carcinoma
SMARCA4 Mutation
Conditions: Official terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Advanced Solid Tumors
BRG1
BRM
Degrader
Metastatic Solid Tumors
Non-Small Cell Lung Cancers
NSCLC
PRT7732
SMARCA2
SMARCA4
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PRT7732
Description:
PRT7732 capsules will be self-administered once daily at the dose-level assigned
Arm group label:
PRT7732
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Southern Highlands Cancer Centre
Address:
City:
Bowral
Zip:
2576
Country:
Australia
Status:
Recruiting
Facility:
Name:
Scientia Clinical Research Ltd
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
Linear Clinical Research Ltd
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Start date:
November 4, 2024
Completion date:
April 2027
Lead sponsor:
Agency:
Prelude Therapeutics
Agency class:
Industry
Source:
Prelude Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06560645
