A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients
NCT Number: NCT06555068
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Unresectable or Metastatic Breast Cancer
Interventions: DRUG: HRS-6209 in Combination with Fulvestrant|DRUG: HRS-6209 in Combination with HRS-1358|DRUG: HRS-6209 in Combination with Letrozole|DRUG: HRS-6209 in Combination with HRS-8080|DRUG: HRS-6209 in Combination with HRS-1358
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 528
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08
Locations: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

Summary:
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

Primary Outcome Measures: 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
Secondary Outcome Measures: Cmax, ss (Stage I), Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)|Tmax, ss (Stage I), Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)|Cmin, ss(Stage I), Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)|AUCss (Stage I), Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)|ORR (objective response rate) (Stage I), every 8 weeks lasting about one year|BOR (best overall response) (Stage I), every 8 weeks lasting about one year|DoR (duration of response) (Stage I), every 8 weeks lasting about one year|CBR (clinical benefit rate) (Stage I), every 8 weeks lasting about one year|PFS (progression-free survival) (Stage I), every 8 weeks lasting about one year|(Serious) AEs (Stage II), 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|Cmax, ss (Stage II), Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)|Tmax, ss (Stage II), Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)|Cmin, ss(Stage II), Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)|AUCss (Stage II), Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)|BOR (best overall response) (Stage II), every 8 weeks lasting about one year|DoR (duration of response) (Stage II), every 8 weeks lasting about one year|CBR (clinical benefit rate) (Stage II), every 8 weeks lasting about one year|PFS (progression-free survival) (Stage II), every 8 weeks lasting about one year