Advanced Melanoma Clinical Trial
Official title:
A Phase Ib,Open,Mono-center,Dose-escalation,Tolerability and Pharmacokinetic Study of Recombinant Humanized Anti-PD-1 mAb for Injection in Combination With Axitinib in Patients With Advanced Kidney Cancer and Melanoma
This is a phase Ib, open, mono-center, dose-escalation, tolerability and pharmacokinetic study evaluating the Recombinant Humanized Anti-PD-1 mAb for Injection in combination with Axitinib in patients with advanced kidney cancer and melanoma who have failed in routine systemic treatment.
This is a phase Ib, open, mono-center, dose-escalation, tolerability and pharmacokinetic
study evaluating the Recombinant Humanized Anti-PD-1 mAb for Injection in combination with
Axitinib in patients with advanced kidney cancer and melanoma who have failed in routine
systemic treatment.The study will be conducted in 2 parts: dose escalation and cohort
expansion.
18 to 24 patients will be enrolled in dose escalation part.This part is to analyze safety and
efficacy of the humanized anti-PD-1 antibody in combination with axitinib and to confirm
dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD). After
finishing the dose escalation part, we will enroll other patients for each tumor types of
recommended dose group to ensure each group have 10 patients. This part is to further analyze
safety and efficacy of the humanized anti-PD-1 antibody.
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