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(Gastric Cancer):Comparative Study 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.
Phase II Part (Pancreatic Cancer): Comparative Study Including a Run-in Cohort Research the efficacy and safety of a combination regimen of GAIA-102 and pembrolizumab added to existing chemotherapy (standard of care) for microsatellite stable advanced pancreatic cancer with malignant ascites at the recommended dosing frequency of GAIA-102 decided in the Phase I part.
Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with malignant ascites, as well as unresectable or advanced recurrent pancreatic cancer.
Abdominal port placement is possible
Diagnosed gastric adenocarcinoma or pancreatic cancer with by histological or cytological examination
The patient has been confirmed to be "negative (not MSS = MSI-high)" by microsatellite instability (MSI) testing, or "proficient mismatch repair (pMMR)" by mismatch repair protein immunohistochemistry testing
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
GAIA-102
Biological/VaccineGAIA-102: 1 vial (2 x 10\^8 cells) as dose at a fixed dose, on 1 to 3 times by weekly for 3 consecutive weeks.
GAIA-102
Biological/VaccineGAIA-102: 1 vial (2 x 10\^8 cells) as dose at a fixed dose, on 3 times by weekly for 3 consecutive weeks.
Pembrolizumab
DrugPembrolizumab 200 mg administered on Day 1.
Pembrolizumab
DrugPembrolizumab 200 mg administered on Day 8.
Trifluridine/tipiracil hydrochloride (FTD/TPI)
DrugTrifluridine/tipiracil hydrochloride (FTD/TPI) will be administered orally twice daily for 5 consecutive days, followed by a 2-day rest period. This cycle will be repeated twice, followed by a 14-day rest period. One course consists of this schedule, and the treatment will be repeated in cycles.
Irinotecan hydrochloride hydrate
DrugIntravenous infusion of 70 mg/m² (based on body surface area) over 90 minutes at 2-week intervals.
Calcium levofolinate hydrate
DrugIntravenous infusion of 200 mg/m² (based on body surface area) over 2 hours.
Fluorouracil
DrugImmediately after completion of the calcium levofolinate hydrate intravenous infusion, fluorouracil 400 mg/m² (based on body surface area) will be administered by intravenous injection, followed by a continuous intravenous infusion of fluorouracil 2,400 mg/m² (based on body surface area) over 46 hours.
6
Treatment groupsSee each treatment group below.
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 in patients with gastric cancer (Phase II)
Overall survival in patients with pancreatic cancer (PhaseⅡ)
Objective Response Rate （ORR) and Disease Control Rate (DCR)(Phase I)
Disease control rate based on RECIST version 1.1. DCR is defined as the proportion of participants whose best overall response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) during the first 24 weeks after the initial administration of study treatment. Stable disease is defined as meeting the RECIST v1.1 criteria for SD at least once at any time point 8 weeks or more after study registration.
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.
Click on the lead sponsor to view all of their trials.
Kyushu University
Lead sponsor
GAIA BioMedicine Inc.
Collaborator
Japan Agency for Medical Research and Development
Collaborator
