drugset / Trial / NCT04856371
Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multicenter, open-label, phase Ib study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 administered orally in combination with standard-of-care ET ± CDK4/6 inhibitor therapies for the treatment of locally advanced, recurrent or metastatic hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Patients will be enrolled in two stages, including dose exploration phase (Stage 1) and dose expansion phase (Stage 2) of each cohort.
Timeline
- Start
- 2021-04
- Primary completion
- 2022-03
- Completion
- 2022-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RISOVALISIB | Small molecule | — | Oral |
| Background | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Background | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Background | Palbociclib | Small molecule | 125 mg | — |