Study of Recombinant Human Anti-PD-1 Monoclonal Antibody for Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumors
- Type
- Interventional
- Phase
- Phase 1
- Design
- Intervention Model: Sequential AssignmentIntervention Model Description: 1 mg per kg, Q2W; 4 mg per kg, Q2W; 10 mg per kg, Q2W; 240 mg fixed dose, Q2WMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Dose escalation study: Primary purpose: To investigate the safety and tolerability of GLS-010 in subjects with advanced solid tumors (mainly gastric cancer, esophageal cancer). Secondary purpose: 1. To characterize the pharmacokinetics(PK) profile of GLS-010; 2. To determine dose-limiting toxicity(D...
Dose escalation study: Primary purpose: To investigate the safety and tolerability of GLS-010 in subjects with advanced solid tumors (mainly gastric cancer, esophageal cancer). Secondary purpose: 1. To characterize the pharmacokinetics(PK) profile of GLS-010; 2. To determine dose-limiting toxicity(DLT), maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for GLS-010; 3. To assess the preliminary anti tumor activity of GLS-010; 4. To assess programmed cell death-1 (PD-1) receptor occupancy. Exploratory purpose: 1. To investigate the preliminary relationship between the expression of the ligand of PD-1 (PD-L1) /PD-L2 and efficacy; 2. To characterize immunogenicity of GLS-010. Expansion study: Primary purpose: To assess the preliminary anti-tumor activity of GLS-010 in subjects with advanced solid tumors(gastric cancer, esophageal cancer); Secondary purpose: 1. To further assess the safety and tolerability of GLS-010; 2. To further assess the safety and tolerability of GLS-010 in subjects with advanced tumors. Exploratory purpose: 1. To assess PD-1 receptor occupancy of GLS-010; 2. To assess the relationship between the expression of PD-L1/PD-L2 and efficacy; 3. To further assess the immunogenicity of GLS-010.
Tracking Information
- NCT #
- NCT03713905
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lin Shen, MM Peking University Cancer Hospital & Institute
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