OncoMatch/Clinical Trials/NCT05438459
GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites
Official title: Clinical Trial of Repeated Intraperitoneal Administration of GAIA-102 in Patients With Advanced Gastrointestinal Cancer (Gastric Cancer / Pancreatic Cancer) of Microsatellite Stable (MSS) With Malignant Ascites (Phase I / II Investigator-initiated Clinical Trial) (GAIA-102-PD Clinical Trial)
Is NCT05438459 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments for gastric cancer.
Treatment: GAIA-102 · Pembrolizumab · Trifluridine/tipiracil hydrochloride (FTD/TPI) · Irinotecan hydrochloride hydrate · Calcium levofolinate hydrate · Fluorouracil — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Gastric Cancer
Pancreatic Cancer
Biomarker criteria
Required: HER2 (ERBB2) wild-type
Required: Mismatch-repair proficient (pMMR / MSS)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: systemic chemotherapy — gastric cancer, Phase I
Patients with gastric cancer who have received 3 or more prior chemotherapy regimens and are refractory or intolerant to these therapies
Must have received: systemic chemotherapy — pancreatic cancer, Phase I
patients with pancreatic cancer who have received 2 or more prior chemotherapy regimens and are refractory or intolerant to these therapies
Must have received: systemic chemotherapy (including immune checkpoint inhibitor) — gastric cancer, Phase II
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
Must have received: systemic chemotherapy (including gemcitabine) (gemcitabine) — pancreatic cancer, Phase II
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
Cannot have received: allogeneic hematopoietic stem cell transplantation
Received allogeneic hematopoietic stem cell transplantation
Lab requirements
Blood counts
Neutrophil ≧1,500/mm3, hemoglobin ≧8.0 g/dL, Platelet ≧75,000/mm3, PT-INR≦ 1.5
Kidney function
eGFR ≧30mL/min/1.73m2
Liver function
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)
Cardiac function
adequate major organs (bone marrow, heart, lungs, liver, kidneys, etc.) function
Adequate major organs (bone marrow, heart, lungs, liver, kidneys, etc.) function: 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05438459 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require MLH1?
Yes, MLH1 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages