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

A Phase Ib，Open-labeled, Multi-center, Dose-exploring Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib and Fluzoparib in Subjects With Recurrent and Metastatic Triple Negative Breast Cancer

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

Study Overview

• Status: Completed
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: SHR-1210 + Apatinib +Fluzoparib

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.; Other Names: Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicity (DLT)	Dose Limiting Toxicity	First cycle (28 days)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Huiping Li, PhD, Beijing Cancer Hosptial

Publications and helpful links

General Publications

• Zhang Q, Shao B, Tong Z, Ouyang Q, Wang Y, Xu G, Li S, Li H. A phase Ib study of camrelizumab in combination with apatinib and fuzuloparib in patients with recurrent or metastatic triple-negative breast cancer. BMC Med. 2022 Oct 3;20(1):321. doi: 10.1186/s12916-022-02527-6.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Actual): February 9, 2021
• Study Completion (Actual): February 9, 2021

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: FZPL-Ib-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No