A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03945604
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-1210 + Apatinib +Fluzoparib — DRUG
    SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.

Study Details

The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple negative breast cancer

Key Dates

Start date
Jun 4, 2019
Status verified
Aug 2022
Primary completion
Feb 9, 2021
Completion
Feb 9, 2021

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-1210 + Apatinib +Fluzoparib
    SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: First cycle (28 days) ]

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