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

Phase 1

Completed

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: SHR-1210 + Apatinib +Fluzoparib

• Registration Number: NCT03945604
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Study Start: 2019-06-04
• Primary Completion: 2021-02-09
• Study Completion: 2021-02-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1210 + Apatinib +Fluzoparib	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 Measures

Name	Time	Method
Dose Limiting Toxicity (DLT)	First cycle (28 days)	Dose Limiting Toxicity

Secondary Outcome Measures

Name	Time	Method
12-months overall survival rate	From the start of treatment to 1 year	12-months overall survival rate
Adverse Events and Serious Adverse Events	from the first drug administration to within 90 days for the last SHR-1210 dose	AEs and SAEs
Duration of response (DoR)	up to 12 months (approx) from the start of treatment
Progression-Free-Survival	up to 12 months (approx) from the start of treatment	PFS
Overall Response Rate (ORR)	up to 12 months (approx) from the start of treatment
Disease Control Rate	up to 12 months (approx) from the start of treatment	DCR

Trial Locations

Locations (1)

Beijing Cancer Hosptial; 🇨🇳 Beijing, Beijing, China