This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.
Women aged 18-75 years with both ends included.
ECOG Physical status 0-1 points.
Patients with histologically confirmed metastatic or locally advanced breast cancer.
Dose-exploration stage: advanced stage has received at least 1 line of endocrine therapy progression in the past, efficacy extension stage: has not received any systemic treatment for advanced disease5.
Symptoms of visceral metastasis.
Previous treatment did not meet trial requirements.
Received nitrosourea or mitomycin within 6 weeks before the first dose in this study; Received major organ surgery, cytotoxic drugs, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical investigational drugs within 4 weeks before the first medication; He received endocrine therapy and palliative radiotherapy within 2 weeks before the first dose.
Less than 14 days after the first dose of CYP3A4; CYP3A4 is treated with a strong inducer <28 days from the date of first administration.
Single group
HRS-8080; Dalpiciclib Isethionate Tablets
DrugHRS-8080 combined with Dalpiciclib Isethionate Tablets
Dose-limiting toxicity (DLT)
Maximum tolerated dose (MTD)
Recommended phase II dose (RP2D)
Safety endpoints: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Steady-state peak concentration (Cmax,ss)
Steady-state peak time (Tmax,ss)
Steady-state valley concentration (Cmin,ss)
Steady-state blood drug concentration-time curve area (AUCss)
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