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

NCT03945604 | Completed Phase 1

• 1 other identifier: FZPL-Ib-105
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity (DLT)

  Dose Limiting Toxicity

  First cycle (28 days)

Secondary Outcomes (6)

• Adverse Events and Serious Adverse Events

  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

  up to 12 months (approx) from the start of treatment

• Progression-Free-Survival

  up to 12 months (approx) from the start of treatment

Study Arms (1)

SHR-1210 + Apatinib +Fluzoparib

EXPERIMENTAL

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

Interventions

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.

Also known as: Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib

SHR-1210 + Apatinib +Fluzoparib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: only female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hosptial

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

• 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.

  PMID: 36184642 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab; apatinib; fluzoparib

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Huiping Li, PhD

  Beijing Cancer Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: June 4, 2019
• Primary Completion: February 9, 2021
• Study Completion: February 9, 2021
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

CN (1)