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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Intravenous injection of GAIA-102 alone or with Pembrolizumab (KEYTRUDA®︎)
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kitakyushu Municipal Medical Center
Kitakyushu, Fukuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Phase I part
Dose Limiting Toxicity
Time frame: Cycle 1 (Cycle period is 28 days)
Phase II part
Objective Response Rate (%)
Time frame: Week 26
Phase I part
* Objective Response Rate * Disease Control Rate
Time frame: Week 26
Phase I part
* Progression-free Survival * Overall Survival
Time frame: 2 year
Phase II part
* Progression-free Survival * Overall Survival
Time frame: 2 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.