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.
Parallel
Phase I part
Biological/VaccineAdministration of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination.
Phase II part
Biological/VaccinePatients will be randomly assigned to receive either GAIA-102 monotherapy or GAIA-102 in combination with pembrolizumab at the recommended dosing regimen confirmed in the Phase I part, or to receive standard therapy. For patients with gastric cancer, the standard therapy group will receive trifluridine/tipiracil hydrochloride (FTD/TPI) only.
Number of participants of Dose Limiting Toxicity (DLT) with GAIA-102 (Phase I)
DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and is defided following events: 1. Grade 4 hemotoxicity or hemotoxicity requiring blood transfusion. 2. Grade 3 or higher non-hematoxicity
Frequency and severity of adverse events(Phase I)
Overall survival period in patients with gastric cancer (Phase II)
One-year survival rate in patients with pancreatic cancer (PhaseⅡ)
Objective Response Rate （ORR) and Disease Control Rate (DCR)(Phase I)
Progression-free Survival(Phase I)
Overall Survival Period(Phase I)
Pharmacokinetics of GAIA-102(Phase I)
The following metrics were meassured as pharmcokinetics; Cmax: The peak plasma concentration of a drug after administration.; tmax. : Time to reach Cmax; Cmin: The lowest (trough) concentration that a drug reaches before the next dose is administered.
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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
