NCT05332574

A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor

A Phase I/II, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific EGFR/cMET/cMET Antibody GB263T in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2 study of GB263T in participants with advanced NSCLC and other solid tumor. The study will consist of a dose-escalation and expansion stage to determine RP2D (Phase 1), and an extension stage (Phase 2) where participants will be enrolled into indication-specific cohorts.

Conditions

• NSCLC
• Other Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	GB263T	Participants will receive IV infusions of GB263T at increased dose level until maximum tolerated dose is reached or all planned doses are administered. Participants will receive GB263T at predefined dose levels and frequency, based upon observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days.

Timeline

• Start date: 2022-05-17
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2022-04-18
• Last updated: 2022-08-05

Locations

4 sites across 1 country: Australia