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Completed

NCT Number: NCT03945604

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hosptial

Beijing, Beijing Municipality, 100142, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-1210 + Apatinib +Fluzoparib

Drug

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

Primary outcomes

  1. Dose Limiting Toxicity (DLT)

    Time frame: First cycle (28 days)

    Dose Limiting Toxicity

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 10, 2019
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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