drugset / Trial / NCT05617313
Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
Phase 2
Terminated
21 enrolled
Jeffrey Clarke
Grid Therapeutics · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-02-17
- Primary completion
- 2025-06-26
- Completion
- 2025-06-26
Outcome
Outcome not reported
Stopped: “Study did not meet the criteria for continuation after interim analysis”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GT103 | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |