Actively Recruiting
GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites
Led by Kyushu University · Updated on 2025-11-18
130
Participants Needed
1
Research Sites
355 weeks
Total Duration
On this page
Sponsors
K
Kyushu University
Lead Sponsor
G
GAIA BioMedicine Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Diagnosed with unresectable or advanced recurrent gastric cancer with peritoneal dissemination or ascites, or unresectable or advanced recurrent pancreatic cancer
- Phase I: Gastric cancer patients with 3 or more prior chemotherapy regimens and refractory or intolerant; pancreatic cancer patients with 2 or more prior chemotherapy regimens and refractory or intolerant
- Phase II: Gastric cancer patients with 2 or more prior chemotherapy regimens including at least 1 with immune checkpoint inhibitor and refractory or intolerant; pancreatic cancer patients with 1 or more prior chemotherapy regimens and refractory or intolerant
- Able to have abdominal port placed
- No serious side effects or allergic reactions to pembrolizumab (for pembrolizumab combination group)
- Diagnosis confirmed by histological or cytological examination
- Negative for microsatellite instability or proficient mismatch repair confirmed by testing
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 for Phase I, 0-1 for Phase II
- Adequate organ function including neutrophils, hemoglobin, platelets, coagulation, liver enzymes, bilirubin, and kidney function
- Expected survival of 3 months or more
- Provided written informed consent
You will not qualify if you...
- Untreated brain metastases
- Diagnosis of meningeal carcinomatosis
- Previous allogeneic hematopoietic stem cell transplantation
- Participation in other clinical trials or use of investigational products within 30 days prior to consent
- Active or suspected autoimmune disease
- Use of high-dose systemic corticosteroids or immunosuppressants within 14 days prior to treatment
- Symptomatic interstitial pneumonia or conditions interfering with imaging for pneumonitis
- Active second cancer requiring treatment
- Need for prohibited combination or supportive therapies during trial
- History of severe hypersensitivity to immune checkpoint inhibitors or related adverse events
- Certain recent complications including cerebrovascular disorders, gastrointestinal perforation, heart failure, bleeding, blood clots, unhealed fractures, digestive ulcers, active infections requiring IV treatment, or HIV positive
- Insufficient recovery time from recent surgeries, radiotherapy, drainage, chemotherapy, or biopsies
- Planned thoracotomy or abdominal surgery during trial
- Significant mental illness making participation difficult
- Pregnancy, lactation, or lack of contraception intention for 4 months post consent
- Allergies to antibiotics or animal-derived ingredients used in treatment
- Investigator judgment of inability to participate in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
Research Team
E
Eiji Oki
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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