NCT05978401

Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer

A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer (Triumph-02)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Guangzhou Gloria Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open Phase I/II study. The trial consists of two parts, Part1 is a dose-escalation/expansion study, Part2 is a combination of GLS-010 and GLS-010+GLS-012 with standard chemotherapy for advanced non-small-cell lung cancer respectively to assess preliminary efficacy at the combination dose.

Conditions

• Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	GLS-012+GLS-010	Two dose levels will be evaluated for GLS-012+GLS-010 administered. GLS-012+GLS-010 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
DRUG	GLS-012+GLS-010	Target dose levels will be evaluated for GLS-012+GLS-010 administered. GLS-012+GLS-010 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
DRUG	GLS-012+GLS-010+pemetrexed+carboplatin	GLS-012+GLS-010 will be given via IV infusion on Day 1 of each 21-day cycle in combination with pemetrexed and carboplatin. Combination treatment will be administered 4\~6 cycles.GLS-012+GLS-010/GLS-010 may continue until disease progression or loss of clinical benefit.
DRUG	GLS-012+GLS-010+paclitaxel+carboplatin	GLS-012+GLS-010 will be given via IV infusion on Day 1 of each 21-day cycle in combination with paclitaxel and carboplatin. Combination treatment will be administered 4\~6 cycles.GLS-012+GLS-010/GLS-010 may continue until disease progression or loss of clinical benefit.

Timeline

• Start date: 2023-08-10
• Primary completion: 2025-04-01
• Completion: 2026-04-01
• First posted: 2023-08-07
• Last updated: 2023-08-07

Locations

1 site across 1 country: China