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Spots Global Cancer Trial Database for Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

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Trial Identification

Brief Title: Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Official Title: Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC

Study ID: NCT05207371

Interventions

Biological

Study Description

Brief Summary: Phase I Part : Confirm the safety of GAIA-102 alone or GAIA-102 with pembrolizumab for advanced / relapse non-small cell lung cancer, and decide recommended dose for Phase II. Phase II Part : Explore the efficacy and safety of GAIA-102 alone or GAIA-102 with pembrolizumab for advanced / relapse non-small cell lung cancer at the recommended dose of GAIA-102 decided in the Phase I part.

Detailed Description: Phase I Part : The GAIA-102 cohort (Level A1\~A3) and the GAIA-102 + Pembrolizumab cohort (Level B1\~B3) will be implemented in a 3 + 3 design. First, start from Level A1 and set the DLT evaluation period until Day 28 of Cycle 1, and confirm the safety up to Cycle 1_Day 28 of Level A1. After that, Level A2 and Level B1 will be started in parallel. After that, unless MTD is recognized, the safety at each level will be confirmed in sequence, and the recommended doses of Phase II part will be determined. Phase II Part : At the recommended number of doses confirmed in Phase I Part, 20 patients will be administered up to 3 cycles, and the safety and efficacy of GAIA-102 alone or with pembrolizumab will be evaluated by ORR.

Keywords

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Kyushu University Hospital, Fukuoka-shi, Fukuoka, Japan

Kitakyushu Municipal Medical Center, Kitakyushu, Fukuoka, Japan

Kurume University Hospital, Kurume, Fukuoka, Japan

Contact Details

Name: Yoshikazu Yonemitsu, MD, PhD

Affiliation: Graduate School of Pharmaceutical Sciences, Kyushu University

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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