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

NCT03852823 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2021-04-30

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin Li, PhD · Shanghai East Hospital

  • Lingying Wu, PhD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Caicun Zhou, PhD · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2022-09-30
Completion
2023-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03852823 on ClinicalTrials.gov