Tolerability and Pharmacokinetics of Toripalimab in Combination With Axitinib in Patients With Kidney Cancer and Melanoma
NCT03086174 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2020-09-30
Summary
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.
Conditions
- Kidney Cancer Stage Iv
- Advanced Melanoma
Interventions
- BIOLOGICAL
-
humanized anti-PD-1 monoclonal antibody Toripalimab
humanized anti-PD-1 monoclonal antibody Toripalimab is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
Sponsors & Collaborators
-
Shanghai Junshi Bioscience Co., Ltd.
lead OTHER
Principal Investigators
-
Jun Guo · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-31
- Primary Completion
- 2019-12-31
- Completion
- 2020-12-31
Countries
- China
Study Locations
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