Clinical Trial

GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
Phase I Part : Confirm the safety of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination for advanced gastrointestinal cancer of microsatellite stable with malignant ascites, and determine the recommended number of doses for Phase II part. Phase II Part : Research the efficacy and safety of as a monotherapy or GAIA-102 and pembrolizumab for advanced gastrointestinal cancer of microsatellite stable with malignant ascites at the recommended dose of GAIA-102 decided in the Phase I part.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-06-24; most recent amendment 2025-11-14.
Trial Details
NCT Number NCT05438459
Lead Sponsor Kyushu University
Collaborators: GAIA BioMedicine Inc., Toho University - Omori Medical Center, Jichi Medical University, Kindai University Hospital, Teikyo University Hospital, Kansai Medical University, Kyushu Cancer Center
Conditions Gastric Cancer, Pancreatic Cancer
Enrollment 130 participants
Start Date 2022-06-08
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-18