NCT05617313

Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer

A Phase II Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Jeffrey Clarke · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, non-randomized Phase II trial is designed to assess the safety and tolerability of GT103 in combination with pembrolizumab in adult subjects with relapsed or refractory, metastatic NSCLC. The study will consist of a safety lead-in of 10-20 patients. A total of 50 patients will be treated with the combination at the safest dose of GT103 as determined in the safety lead-in. If 10 additional patients are enrolled to the dose level -1 then the maximum of 60 subjects may be accrued to this trial.

Conditions

• Non Small Cell Lung Cancer
• Metastatic NSCLC
• Recurrent Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg intravenously on Day 1 of cycle.
DRUG	GT103	10mg/kg taken intravenously on Day 1 of cycle.

Timeline

• Start date: 2023-02-17
• Primary completion: 2025-06-26
• Completion: 2025-06-26
• First posted: 2022-11-15
• Last updated: 2025-07-30

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study