OncoMatch/Clinical Trials/NCT05438459
GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites
Is NCT05438459 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Phase I part and Phase II part for gastric cancer.
Treatment: Phase I part · Phase II part — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Gastric Cancer
Pancreatic Cancer
Disease stage
Required: Stage ADVANCED RECURRENT
Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or advanced recurrent pancreatic cancer.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: cytotoxic chemotherapy — gastric cancer, phase I
gastric cancer who have received 3 or more prior chemotherapy regimens and are refractory or intolerant to these therapies
Must have received: cytotoxic chemotherapy — pancreatic cancer, phase I
pancreatic cancer who have received 2 or more prior chemotherapy regimens and are refractory or intolerant to these therapies
Must have received: cytotoxic chemotherapy — 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: immune checkpoint inhibitor — gastric cancer, phase II
including at least 1 regimen containing an immune checkpoint inhibitor, and are refractory or intolerant to these therapies
Must have received: cytotoxic chemotherapy — pancreatic cancer, phase II
pancreatic cancer who have received 1 or more prior chemotherapy regimens 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 ≥30 mL/min/1.73m2
Liver function
AST, ALT ≤ 3x upper limit of reference value; T-Bil ≤ 2x upper limit of reference value (≤ 3.0mg/dL if 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.
What disease stage is eligible?
Stage ADVANCED RECURRENT is required.
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