Phase Ib First in Human Dose Escalation of GT103 in Refractory, Advanced Stage Non-Small Cell Lung Cancer (TOP 1902)

Phase 1

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: GT103

• Registration Number: NCT04314089
• Lead Sponsor: Edward Patz

Brief Summary

The purpose of this research study is to determine the maximum tolerated dose of GT103 and investigate the safety and effectiveness of the study drug.

Detailed Description

This is a Phase Ib First in Human Dose Escalation of GT103 in Refractory, Advanced Stage (III/IV) and Recurrent Non-Small Cell Lung Cancer.

Patients with histologically confirmed recurrent, advanced stage of lung cancer, and there are no other standard therapies available may be eligible to participate in this study.

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-18
• Study Start: 2020-06-09
• Primary Completion: 2024-04-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT103	GT103	Participants will receive GT103 every 3 weeks. GT103 will be escalated from .3mg/kg up 10 to mg/kg or until MTD is found

Primary Outcome Measures

Name	Time	Method
Time for the concentration of GT103 to reach half of the level administered	2 years
Recommended phase II dose (RP2D) of GT103	2 years	Recommended dose for the Phase II portion of the study
To determine the maximum tolerated dose (MTD), if any	2 years	The number and proportion of subjects at each dose level who experience a DLT

Secondary Outcome Measures

Name	Time	Method
Response Rate	2 years	Response rate is defined as the proportion of treated subjects with a complete or partial response. The response rate associated with the dose chosen to be the RP2D will also be estimated.
Progression-Free Survival	2 years	PFS is defined as the time between initiation of treatment and initial failure (disease progression or death). If the patient remains alive without disease progression at the time of analysis, PFS will be censored at the time of last follow-up. If the patient starts alternative anti-cancer therapy before progression, PFS will be censored at the time that the alternative treatment is initiated.
Overall Survival	2 years	OS is defined as the time between initiation of treatment and death.

Trial Locations

Locations (3)

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Advent Health; 🇺🇸 Celebration, Florida, United States