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

Primary Purpose

Triple Negative Breast Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-1210 + Apatinib +Fluzoparib
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Beijing Cancer Hosptial

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR-1210 + Apatinib +Fluzoparib

Arm 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

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity (DLT)
Dose Limiting Toxicity

Secondary Outcome Measures

Adverse Events and Serious Adverse Events
AEs and SAEs
Overall Response Rate (ORR)
Duration of response (DoR)
Disease Control Rate
DCR
Progression-Free-Survival
PFS
12-months overall survival rate
12-months overall survival rate

Full Information

First Posted
May 9, 2019
Last Updated
August 9, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03945604
Brief Title
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
February 9, 2021 (Actual)
Study Completion Date
February 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHR-1210 + Apatinib +Fluzoparib
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
SHR-1210 + Apatinib +Fluzoparib
Other Intervention Name(s)
Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib
Intervention 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.
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity (DLT)
Description
Dose Limiting Toxicity
Time Frame
First cycle (28 days)
Secondary Outcome Measure Information:
Title
Adverse Events and Serious Adverse Events
Description
AEs and SAEs
Time Frame
from the first drug administration to within 90 days for the last SHR-1210 dose
Title
Overall Response Rate (ORR)
Time Frame
up to 12 months (approx) from the start of treatment
Title
Duration of response (DoR)
Time Frame
up to 12 months (approx) from the start of treatment
Title
Disease Control Rate
Description
DCR
Time Frame
up to 12 months (approx) from the start of treatment
Title
Progression-Free-Survival
Description
PFS
Time Frame
up to 12 months (approx) from the start of treatment
Title
12-months overall survival rate
Description
12-months overall survival rate
Time Frame
From the start of treatment to 1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
only female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huiping Li, PhD
Organizational Affiliation
Beijing Cancer Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hosptial
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36184642
Citation
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.
Results Reference
derived

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

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