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

• Status: Unknown status
• Trial end date: 2021-08-20
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Antibodies; Apatinib

Criteria

Inclusion Criteria:

• Signed the informed consent.

• Female aged ≥18 years old.

• Histologically diagnosed patients with recurrent and metastatic triple negative breast cancer.

• No more than 2-line chemotherapy failed at the stage of recurrence and metastasis .

• Patients who have been treated with platinum-based regimen at the stage of recurrence/metastasis need non-disease progression (non-pd)during treatment

• At least one measuring lesion that comfirmed by RECIST v1.1 standard.

• The patients can swallow pills.

• Have a life expectancy of at least 12 weeks.

• The functions of vital organs meet protocal requirements.

Exclusion Criteria:

• Subjects had any history of active autoimmune disease .

• Subjects had previously been treated with anti-PD-1 and PD-L1 antibodies, or was known to be allergic to antibody drugs, or had previously been treated with apatinib, or had previously been treated with PARP inhibitors.

• Subjects have untreated central nervous system metastasis.

• History of hypertension and antihypertensive medications are not well controlled.

• Some clinical symptoms or diseases of the heart that are not well controlled.

• History of immunodeficiency including HIV-positive.

• Subjects had active infections.