This study is designed to determine if treatments with the combination of HRS-8080 and SHR-A1811, the combination of HRS-8080 and SHR-A2009, the combination of SHR-A2009 and SHR-1316 are safe, tolerable, and has anti-cancer activity in patients with unresectable or metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Participants will receive HRS-8080 and SHR-A1811
Participants will receive HRS-8080 and SHR-A2009
Participants will receive SHR-A2009 and SHR-1316
Hunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGDose Limited Toxicity(DLT)
Phase 1
Time frame: up to 1 cycle (21 days)
Maximum Tolerable Dose(MTD)
Phase 1
Time frame: up to 1 cycle (21 days)
Recommended Phase 2 Dose(RP2D)
Phase 1
Time frame: up to 1 cycle (21 days)
Safety endpoints: the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (rated based on CTCAE V5.0)
Phase 1
Time frame: up to 12 months
Efficacy endpoint: objective response rate (ORR)
Phase 2
Time frame: up to 12 months
level of SHR-A1811 ADA and Nab
Phase 1
Time frame: up to 12 months
level of SHR-A2009 ADA and Nab
Phase 1
Time frame: up to 12 months
level of adebrelimab ADA and Nab
Phase 1
Time frame: up to 12 months
Objective response rate (ORR)
Phase 1
Time frame: up to 12 months
Best overall response (BOR)
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Phase 1
Time frame: up to 12 months
Duration of response (DoR)
Phase 1
Time frame: up to 12 months
Disease control rate (DCR)
Phase 1
Time frame: up to 12 months
Clinical benefit rate (CBR)
Phase 1
Time frame: up to 12 months
Progression-free survival (PFS)
Phase 1
Time frame: up to 12 months
Safety endpoints: incidence and severity of AEs and SAEs (rated based on CTCAE V5.0)
Phase 2
Time frame: up to 12 months
level of SHR-A1811 ADA and Nab
Phase 2
Time frame: up to 12 months
level of SHR-A2009 ADA and Nab
Phase 2
Time frame: up to 12 months
level of adebrelimab ADA and Nab
Phase 2
Time frame: up to 12 months
Best overall response (BOR)
Phase 2
Time frame: up to 12 months
Duration of response (DoR)
Phase 2
Time frame: up to 12 months
Disease control rate (DCR)
Phase 2
Time frame: up to 12 months
Clinical benefit rate (CBR)
Phase 2
Time frame: up to 12 months
Progression-free survival (PFS)
Phase 2
Time frame: up to 12 months