NCT03852823

Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours

An Open, Multi-dose, Dose Escalation and Cohort Expansion, Phase Ⅰ Study of the Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open, multi-dose, dose escalation and cohort expansion, phase Ⅰ study to investigate the safety, tolerability, efficiency, pharmacokinetics, immunogenicity of SG001 in subjects with advanced tumours.

Detailed description

Phase Ⅰa: open, multi-dose, dose escalation. Phase Ⅰb: open, fixed-dose, cohort expansion.

Conditions

• Advanced Solid Tumours
• Cervical Cancer
• Malignant Mesothelioma
• Lymphoma
• Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SG001	Phase Ia: Subjects will receive intravenous infusion of SG001 following a sequential dose escalation design (1mg/kg, 3mg/kg and 10mg/kg). Dose limited toxicity (DLT) will be observed within 21 days after the first administration, then subjects can continuously receive SG001 every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal from the trial. Phase Ib: Subjects will receive intravenous infusion of SG001 at the dose of 240 mg every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal from the trial.

Timeline

• Start date: 2019-05-23
• Primary completion: 2022-09-01
• Completion: 2023-03-01
• First posted: 2019-02-25
• Last updated: 2021-04-30

Locations

1 site across 1 country: China