A Phase 1/2 interventional study of GAIA-102 and GAIA-102 in Gastric Cancer and Pancreatic Cancer, sponsored by Kyushu University. Recruiting at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Kyushu University · Phase 1/2, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 176 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Kyushu University is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with gastric cancer who have received 3 or more prior chemotherapy regimens and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 2 or more prior chemotherapy regimens and are refractory or intolerant to these therapies.
Phase II:
Patients with gastric cancer who have received 2 or more prior chemotherapy regimens, including at least 1 regimen containing an immune checkpoint inhibitor, and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 1 or more prior chemotherapy regimens, including at least 1 regimen containing gemcitabine, and are refractory or intolerant to these therapies.
Only patients with HER2-negative gastric cancer are eligible.
No medical history of serious adverse reactions or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)
PhaseⅡ(gastric cancer):
No medical history of serious adverse reactions or allergic reactions to pembrolizumab or trifluridine/tipiracil hydrochloride (FTD/TPI) ,or to any components of these agents.
PhaseⅡ(pancreatic cancer):
No medical history of serious adverse reactions or allergic reactions to pembrolizumab, irinotecan hydrochloride hydrate, fluorouracil, or calcium levofolinate hydrate ,or to any components of these agents.
Phase I ：0-2, Phase II ：0-1
Neutrophil ≧1,500/mm3, hemoglobin ≧8.0 g/dL, Platelet ≧75,000/mm3, PT-INR≦ 1.5 , AST, ALT≦ 3 times the upper limit of reference value, T-Bil≦ 2 times the upper limit of reference value (T-Bil ≦ 3.0mg/dL , when drainage for obstructive jaundice), eGFR ≧30mL/min/1.73m2
Exclusion Criteria:
Surgery (including exploratory laparotomy / examination laparoscope): 2 weeks, Palliative radiotherapy: 1 week, Thoracic drainage: 1 week, Pretreatment antineoplastic (from the last administration): 3 weeks, Biopsy with incision, thoracic biopsy, treatment for trauma (excluding patients without wound healing), etc : 2 weeks
Participants receive GAIA-102 as monotherapy.
Biological: GAIA-102
Participants receive GAIA-102 in combination with pembrolizumab.
Biological: GAIA-102 · Drug: Pembrolizumab
Participants receive GAIA-102 in combination with pembrolizumab.
Biological: GAIA-102 · Drug: Pembrolizumab
Participants receive trifluridine/tipiracil hydrochloride (FTD/TPI).
Drug: Trifluridine/tipiracil hydrochloride (FTD/TPI)
Participants receive GAIA-102 in combination with pembrolizumab, irinotecan hydrochloride hydrate, calcium levofolinate hydrate, and fluorouracil.
Biological: GAIA-102 · Drug: Pembrolizumab · Drug: Irinotecan hydrochloride hydrate · Drug: Calcium levofolinate hydrate · Drug: Fluorouracil
Participants receive standard therapy consisting of irinotecan hydrochloride hydrate, calcium levofolinate hydrate, and fluorouracil.
Drug: Irinotecan hydrochloride hydrate · Drug: Calcium levofolinate hydrate · Drug: Fluorouracil
GAIA-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: 1 vial (2 x 10\^8 cells) as dose at a fixed dose, on 3 times by weekly for 3 consecutive weeks.
Pembrolizumab 200 mg administered on Day 1.
Pembrolizumab 200 mg administered on Day 8.
Trifluridine/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.
Intravenous infusion of 70 mg/m² (based on body surface area) over 90 minutes at 2-week intervals.
Intravenous infusion of 200 mg/m² (based on body surface area) over 2 hours.
Immediately 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.
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
Time frame: Cycle 1 (Cycle period is 28 days)
Frequency and severity of adverse events(Phase I)
Time frame: 2 year
Overall survival in patients with gastric cancer (Phase II)
Time frame: up to 4 years
Overall survival in patients with pancreatic cancer (PhaseⅡ)
Time frame: up to 5 years(up to 5.5 years for the Run-in Cohort）
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.
Time frame: Up to 24 weeks after first dose
Progression-free Survival(Phase I)
Time frame: 2 year
Overall Survival Period(Phase I)
Time frame: 2 year
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.
Time frame: pre-dose
Biomarker of GAIA-102(Phase I)
Protein expression levels are measured in ascites and blood as biomarkers. The following are the markers to be measured; CCL3/CCL4/CCL5/CCL20/CXCL9/CXCL10/CXCL11
Time frame: pre-dose
Objective Response Rate and Disease Control Rate(Phase II)
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.
Time frame: up to 24 weeks after first dose
Progression-free Survival (Phase II)
Time frame: up to 4 years for patients with gastric cancer and up to 5 years for patients with pancreatic cancer (up to 5.5 years for the Run-in Cohort).
Objective Response Period and Period until Objective Response (Phase II)
Time frame: up to 2 years
One-year survival rate in patients (Phase II)
Time frame: 1 year
Frequency and severity of adverse events (Phase II)
Time frame: up to 4 years for patients with gastric cancer and up to 5 years for patients with pancreatic cancer (up to 5.5 years for the Run-in Cohort).
Biomarker of GAIA-102(Phase II)
Protein expression levels are measured in ascites and blood as biomarkers. The following are the markers to be measured; CCL3/CCL4/CCL5/CCL20/CXCL9/CXCL10/CXCL11
Time frame: pre-dose
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