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Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib

NCT03976856 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-03-03

No results posted yet for this study

Summary

This study is a multi-center, open-label, dose-finding phase Ib clinical study with extension phase, which is aimed at evaluating the efficacy and safety of GB226 combined with fruquintinib in treatment of relapsed or metastatic NSCLC patients with EGFR-sensitive mutations who have failed to respond to EGFR-TKI treatment,evaluating the pharmacokinetic characteristics of GB226 and fruquintinib, and the immunogenicity of GB226, and preliminarily evaluating the antitumor activity of GB226 and fruquintinib.

Conditions

  • Metastatic Non-small Cell Lung Cancer

Interventions

DRUG

GB226

Geptanolimab, 210mg，q2w，ivgtt.

DRUG

Fruquintinib

Fruquintinib, 3mg or 4mg or 5mg, qd.po. 3 weeks-on,1 week-off

Sponsors & Collaborators

  • Hutchison Medipharma Limited

    collaborator INDUSTRY

  • Genor Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shun Lu, Doctor · Shanghai Chest Hospital

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
2019-07-23
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03976856 on ClinicalTrials.gov