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

Triple Negative Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945604
• Other study ID #: FZPL-Ib-105
• Status: Completed
• Phase: Phase 1
• Start date: June 4, 2019
• Est. completion date: February 9, 2021

Study information

• Verified date: August 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 9, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Cancer Hosptial	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity (DLT)	Dose Limiting Toxicity	First cycle (28 days)
Secondary	Adverse Events and Serious Adverse Events	AEs and SAEs	from the first drug administration to within 90 days for the last SHR-1210 dose
Secondary	Overall Response Rate (ORR)		up to 12 months (approx) from the start of treatment
Secondary	Duration of response (DoR)		up to 12 months (approx) from the start of treatment
Secondary	Disease Control Rate	DCR	up to 12 months (approx) from the start of treatment
Secondary	Progression-Free-Survival	PFS	up to 12 months (approx) from the start of treatment
Secondary	12-months overall survival rate	12-months overall survival rate	From the start of treatment to 1 year