Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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).

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

GT103

Jeffrey Clarke, MD

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.

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

ORR will be defined as the proportion of patients with radiographic complete or partial response rate per RECIST v1.1.

Safety and tolerability will be assessed by the proportion of patients with DLT observed during the first cycle of treatment. NCI CTCAE v5 will be used to grade adverse events.

The time for the concentration of GT103 to reach half of the level administered when given in combination with Pembrolizumab (T1/2) will be measured by pharmacokinetic analysis.

The time it takes GT103 to reach maximum concentration when administered with Pembrolizumab will be measured by pharmacokinetic analysis.

The maximum concentration (Cmax) of GT103 in the serum after administration in combination with Pembrolizumab will be measured by pharmacokinetic analysis.

Area under the plasma concentration vs time curve (AUC) for GT103 will be measured by pharmacokinetic analysis.

PFS is defined as the time between initiation of treatment and progression by RECIST 1.1 or death.

OS is defined as the time between initiation of treatment and death from any cause.

Spots Global Cancer Trial Database for gt103

Every month we try and update this database with for gt103 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gt103

Every month we try and update this database with for gt103 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gt103 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.