drugset / Trial / NCT05438459
GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites
Phase 1/2
Recruiting
130 enrolled
Kyushu University
GAIA BioMedicine Inc. · collabJichi Medical University · collabKansai Medical University · collabKindai University Hospital · collabKyushu Cancer Center · collabTeikyo University Hospital · collabToho University - Omori Medical Center · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-06-08
- Primary completion
- 2028-12-31
- Completion
- 2029-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GAIA-102 | Cell therapy | 2e+08 cells | Intrathecal |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |