A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
Purpose
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.
Conditions
- Advanced Solid Tumor
- Metastatic Solid Tumor
- Non-small Cell Lung Carcinoma
- SMARCA4 Mutation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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).
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
San Francisco, California 94158
Brigitte Harris Cancer Pavilion
Detroit, Michigan 48202
Detroit, Michigan 48202
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York 10065
New York, New York 10065
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
SCRI Oncology Partners
Nashville, Tennessee 37203
Nashville, Tennessee 37203
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
More Details
- NCT ID
- NCT06560645
- Status
- Recruiting
- Sponsor
- Prelude Therapeutics
Study Contact
Study Contact (Please Do Not Disclose Personal Information)See Email
clinicaltrials@preludetx.com
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.