Kyushu University Hospital had received IND clearance from the PMDA for a Phase Ⅰ/Ⅱ investigator-initiated clinical trial of GAIA-102 for patients with Advanced Gastrointestinal Cancer of Microsatellite Stable (“MSS”) with Malignant Ascites

GAIA BioMedicine Inc. (“GAIA”), a pioneer in developing innovative immunotherapies, announced that Kyushu University Hospital had received IND clearance from the PMDA for a Phase Ⅰ/Ⅱ investigator-initiated clinical trial for patients with Advanced Gastrointestinal Cancer of Microsatellite Stable (“MSS”) with Malignant Ascites. GAIA provides its leading modality, GAIA-102, NK-cell-like cells, to this trial.
Phase Ⅰ is conducted with a singular arm, non-randomized, open, and non-comparison study, while Phase Ⅱ will be undertaken with a randomized, opened, and comparison basis.
The primary objective of this trial is to evaluate GAIA-102’s safety and clinical benefit for patients with the disease.
Phase Ⅰ has a typical “3 + 3” design. This phase assesses the safety and tolerability of GAIA-102 as monotherapy and the combination therapy of GAIA-102 with Pembrolizumab, determining the recommended dosing frequency.
Subject to an Independent Data Monitoring Committee’s (IDMC) review of the safety data of all enrolled subjects in each cohort at each dose level, the dose escalation to the next level will be determined.
Phase Ⅱ is an exploratory trial designed to determine the safety and clinical efficacy of the monotherapy of GAIA-102, or the combination therapy of GAIA-102 and Pembrolizumab for Advanced Gastrointestinal Cancer of MSS with Malignant Ascites via randomly assigned treatment cohorts.
This study is subsidized under the Translational Research Program Seeds C(b-1) of AMED (Japan Agency for Medical Research and Development), and Dr. Eiji Oki, the Department of Surgery and Science at Kyushu University Hospital, serves as the principal investigator for this trial.

ClinicalTrials.gov Identifier: NCT05438459
https://www.amed.go.jp/koubo/16/01/1601C_00005.html

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