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
- Esophageal Adenocarcinoma
- Esophageal Squamous Cell Carcinoma
- Gastric Adenocarcinoma
- Gastric Squamous Cell Carcinoma
- Gastroesophageal Junction Adenocarcinoma
- Gastroesophageal Junction Squamous Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- 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 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).
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
More Details
- NCT ID
- NCT06560645
- Status
- Terminated
- Sponsor
- Prelude Therapeutics
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.