NCT03976856

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

A Phase Ib Clinical Study With Extension Phase to Evaluate Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib in the Treatment of Relapsed or Metastatic NSCLC Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, it is planned to enroll at least 42 NSCLC patients who meet relevant criteria. This study includes dose escalation phase and extension phase of the combined therapy: three combined dose groups are planned in the dose escalation phase; the dose extension phase is divided into two cohorts.

Conditions

• Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	GB226	Geptanolimab, 210mg，q2w，ivgtt.
DRUG	Fruquintinib	Fruquintinib, 3mg or 4mg or 5mg, qd.po. 3 weeks-on,1 week-off

Timeline

• Start date: 2019-07-23
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2019-06-06
• Last updated: 2021-03-03

Locations

1 site across 1 country: China