Status:
ACTIVE_NOT_RECRUITING
A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
Lead Sponsor:
Prelude Therapeutics
Conditions:
Advanced Solid Tumor
Metastatic Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
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 degrade...
Eligibility Criteria
Inclusion
- 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
- 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 other malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, prostate adenocarcinoma with Gleason score of 3+3 or less, 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).
Key Trial Info
Start Date :
November 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06560645
Start Date
November 4 2024
End Date
April 1 2027
Last Update
November 13 2025
Active Locations (28)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
2
Brigitte Harris Cancer Pavilion
Detroit, Michigan, United States, 48202
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
4
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States, 10065