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

NCT05617313 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-07-30

No results posted yet for this study

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

DRUG

Pembrolizumab

200 mg intravenously on Day 1 of cycle.

DRUG

GT103

10mg/kg taken intravenously on Day 1 of cycle.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Grid Therapeutics

    collaborator INDUSTRY

  • Jeffrey Clarke

    lead INDUSTRY

Principal Investigators

  • Jeffrey Clarke, MD · Duke Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-17
Primary Completion
2025-06-26
Completion
2025-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617313 on ClinicalTrials.gov