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出境医 / 临床实验 / A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC

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

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

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: SHR-1210 + Apatinib +Fluzoparib Phase 1

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 aptinib and fluzoparib

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : April 20, 2021
Estimated Study Completion Date : August 20, 2021
Arms and Interventions
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 Name: Treatment group ： PD-1 antibody SHR-1210 combination with aptinib and fluzoparib
Outcome Measures
Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: First cycle (28 days) ]
    Dose Limiting Toxicity


Secondary Outcome Measures :
  1. Adverse Events and Serious Adverse Events [ Time Frame: from the first drug administration to within 90 days for the last SHR-1210 dose ]
    AEs and SAEs

  2. Overall Response Rate (ORR) [ Time Frame: up to 12 months (approx) from the start of treatment ]
  3. Duration of response (DoR) [ Time Frame: up to 12 months (approx) from the start of treatment ]
  4. Disease Control Rate [ Time Frame: up to 12 months (approx) from the start of treatment ]
    DCR

  5. Progression-Free-Survival [ Time Frame: up to 12 months (approx) from the start of treatment ]
    PFS

  6. 12-months overall survival rate [ Time Frame: From the start of treatment to 1 year ]
    12-months overall survival rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Zongfei Zongfei Dai, master 18616240775 zongfeidai@hrglobe.cn
Contact: Quanren Wang, PhD 18036618570 wangquanren@hrglobe.cn

Locations
Layout table for location information
China, Beijing
Beijing Cancer Hosptial Recruiting
Beijing, Beijing, China, 100142
Contact: Huiping Li, MD       huipingli2012@hotmail.com   
Contact: MD         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Huiping Li, PhD Beijing Cancer Hosptial
Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date March 19, 2020
Actual Study Start Date  ICMJE June 4, 2019
Estimated Primary Completion Date April 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019) 		Dose Limiting Toxicity (DLT) [ Time Frame: First cycle (28 days) ]
Dose Limiting Toxicity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Adverse Events and Serious Adverse Events [ Time Frame: from the first drug administration to within 90 days for the last SHR-1210 dose ]
    AEs and SAEs
  • Overall Response Rate (ORR) [ Time Frame: up to 12 months (approx) from the start of treatment ]
  • Duration of response (DoR) [ Time Frame: up to 12 months (approx) from the start of treatment ]
  • Disease Control Rate [ Time Frame: up to 12 months (approx) from the start of treatment ]
    DCR
  • Progression-Free-Survival [ Time Frame: up to 12 months (approx) from the start of treatment ]
    PFS
  • 12-months overall survival rate [ Time Frame: From the start of treatment to 1 year ]
    12-months overall survival rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC
Official Title  ICMJE 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
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 aptinib and fluzoparib
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Triple Negative Breast Cancer
Intervention  ICMJE 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 Name: Treatment group ： PD-1 antibody SHR-1210 combination with aptinib and fluzoparib
Study Arms  ICMJE 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
Intervention: Drug: SHR-1210 + Apatinib +Fluzoparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019) 		52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 20, 2021
Estimated Primary Completion Date April 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: only female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zongfei Zongfei Dai, master 18616240775 zongfeidai@hrglobe.cn
Contact: Quanren Wang, PhD 18036618570 wangquanren@hrglobe.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945604
Other Study ID Numbers  ICMJE FZPL-Ib-105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Huiping Li, PhD Beijing Cancer Hosptial
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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