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Monoclonal Antibodies

GT103 + Pembrolizumab for Lung Cancer

Phase 2
Waitlist Available
Led By Jeffrey Clarke, MD
Research Sponsored by Jeffrey Clarke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the safety and tolerability of combining GT103, a new drug, with pembrolizumab, an immune-boosting cancer treatment, in adults with advanced lung cancer that has returned or not responded to previous treatments. Pembrolizumab is an immune-boosting treatment that has shown effectiveness in patients with lung cancer and has been tested with other treatments.

Who is the study for?
Adults over 18 with Stage III-IV recurrent or metastatic NSCLC, who have relapsed or are refractory to immunotherapy and possibly chemotherapy. They must have adequate organ function, not be pregnant or breastfeeding, use contraception if of childbearing potential, and cannot have other conditions that might interfere with the trial.
What is being tested?
The trial is testing GT103 in combination with Pembrolizumab for safety and effectiveness in treating NSCLC. It includes an initial phase to determine the safest dose followed by treatment of up to 60 patients at this dose level.
What are the potential side effects?
While specific side effects for GT103 aren't listed, Pembrolizumab can cause immune system reactions affecting organs, fatigue, infusion-related reactions like fever or chills, skin rash, digestive issues such as diarrhea or liver inflammation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess the Frequency and Severity of Adverse Events
Objective Response Rate (ORR)
Secondary study objectives
Characterize PK Profile: Area Under the Plasma Concentration vs Time Curve (AUC)
Characterize PK Profile: Peak Plasma Concentration (Cmax)
Characterize PK Profile: T1/2 of GT103 in combination with Pembrolizumab
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental GroupExperimental Treatment2 Interventions
Pembrolizumab will be given intravenously on Day 1 of the 21 day cycle (For all cycles). GT103 dose will be determined by the safety lead in prior to the study. Dosing calculations should be based on actual body weight where applicable. It will be taken intravenously on Day 1 of the 21 day cycle (For all cycles).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2850

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway that cancer cells use to evade the immune system, thereby reactivating T-cells to recognize and attack cancer cells. GT103, though its mechanism is unspecified, is being studied in combination with pembrolizumab, suggesting it may also modulate the immune response. These mechanisms are important for NSCLC patients as they leverage the body's immune system to target cancer cells, potentially offering more effective and less toxic treatment options compared to traditional chemotherapy.
A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.

Find a Location

Who is running the clinical trial?

Jeffrey ClarkeLead Sponsor
3 Previous Clinical Trials
92 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,966 Previous Clinical Trials
5,176,652 Total Patients Enrolled
Grid TherapeuticsUNKNOWN

Media Library

GT103 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05617313 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Experimental Group
Non-Small Cell Lung Cancer Clinical Trial 2023: GT103 Highlights & Side Effects. Trial Name: NCT05617313 — Phase 2
GT103 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05617313 — Phase 2
~9 spots leftby Jan 2026