Beijing Cancer Hosptial
Beijing, Beijing Municipality, 100142, China
NCT Number: NCT03945604
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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Notify Me18 year–80 year
Female
Interventional
Phase 1
Beijing, Beijing Municipality, 100142, China
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: First cycle (28 days)
Dose Limiting Toxicity
Time frame: from the first drug administration to within 90 days for the last SHR-1210 dose
AEs and SAEs
Time frame: up to 12 months (approx) from the start of treatment
Time frame: up to 12 months (approx) from the start of treatment
Time frame: up to 12 months (approx) from the start of treatment
DCR
Time frame: up to 12 months (approx) from the start of treatment
PFS
Time frame: From the start of treatment to 1 year
12-months overall survival rate
Jiangsu HengRui Medicine Co., Ltd.
Industry
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
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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