drugset / Trial / NCT05508906
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation). Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus. Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.
Timeline
- Start
- 2022-08-31
- Primary completion
- 2027-12-31
- Completion
- 2028-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | 250 mg | Oral |
| Subject | Alpelisib | Small molecule | 300 mg | Oral |
| Subject | Atirmociclib | Small molecule | 300 mg | Oral |
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Subject | Palazestrant | Small molecule | 60 mg | Oral |
| Subject | Palazestrant | Small molecule | 90 mg | Oral |
| Subject | Ribociclib | Small molecule | 600 mg | Oral |