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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Triple Negative Breast Cancer

Treatments: Drug: SHR-1210 + Apatinib +Fluzoparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03945604

FZPL-Ib-105

Details and patient eligibility

About

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

Full description

Drug: 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.

Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib

Enrollment: 32 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 confirmed 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

SHR-1210 + Apatinib +Fluzoparib

Experimental group

Description:

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

Treatment:

Drug: SHR-1210 + Apatinib +Fluzoparib