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An Open-Label, Multi-Center Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Patients With Advanced Unresectable or Metastatic Breast Cancer
The study is being conducted to evaluate the safety, PK and efficacy of HRS-6209 in Combination with Fulvestrant, Letrozole, HRS-8080, or HRS-1358 for advanced unresectable or metastatic breast cancer
Details
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 528 |
| Start date | 2024-08-12 |
| Completion | 2026-08 |
Conditions
- Advanced Unresectable or Metastatic Breast Cancer
Interventions
- HRS-6209 in Combination with Fulvestrant
- HRS-6209 in Combination with HRS-1358
- HRS-6209 in Combination with Letrozole
- HRS-6209 in Combination with HRS-8080
- HRS-6209 in Combination with HRS-1358
Primary outcomes
- DLT (dose-limiting toxicity)-Stage I (dose exploration) — 28 days after the first dose
- MTD (maximum tolerated dose) -Stage I (dose exploration) — 28 days after the first dose
- RP2D (recommended phase II dose) -Stage I (dose exploration) — 28 days after the first dose
- (Serious) AEs-Stage I (dose exploration) — every week in Cycle 1 (28 days after the first dose), every 2 weeks in Cycle 2 (28 days after the second dose), every 4 weeks from Cycle 3 and thereafter (28 days after each dose), lasting about one year
- ORR ( objective response rate )-Stage II (efficacy expansion) — every 8 weeks lasting about one year
Countries
China