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.
Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or advanced recurrent pancreatic cancer.
Abdominal port placement is possible
No medical history of serious side effects or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)
Diagnosed gastric adenocarcinoma or pancreatic cancer with by histological or cytological examination
Untreated cranial metastases.
Diagnosed with meningeal carcinomatosis
Received allogeneic hematopoietic stem cell transplantation
Participated in other clinical trials / clinical trials within 30 days prior to obtaining written consent and used or had used the investigational product or investigational equipment.
Kyushu University
Lead sponsor
GAIA BioMedicine Inc.
Collaborator
Toho University - Omori Medical Center
Collaborator
Jichi Medical University
Collaborator
Kindai University Hospital
Collaborator
Teikyo University Hospital
Collaborator
Kansai Medical University
Collaborator
Kyushu Cancer Center
Collaborator