Status:
RECRUITING
GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites
Lead Sponsor:
Kyushu University
Collaborating Sponsors:
GAIA BioMedicine Inc.
Toho University - Omori Medical Center
Conditions:
Gastric Cancer
Pancreatic Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or advanced recurrent pancreatic cancer.
- Phase I:
- 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 and are refractory or intolerant to these therapies.
- Abdominal port placement is possible
- No medical history of serious side effects or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)
- 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
- The Eastern Cooperative Oncology Group (ECOG) performance status(PS) at the time of informed consent meets the following conditions.
- Phase I ：0-2
- Phase II ：0-1
- Patient aged 20years or older
- 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
- Expected to survive for 3 months or more at the enrollment
- Written informed consent
Exclusion
- 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.
- Existence or suspected active autoimmune disease
- Continued systemic immunosuppressive therapy with corticosteroids in excess of 10 mg / day in terms of prednisolone or other immunosuppressants within 14 days prior to investigational product administration
- Symptomatic interstitial pneumonia, or even if it is not symptomatic, it may interfere with diagnostic imaging in detecting new pneumonitis caused by the investigational product used in the clinical trial.
- Have active double cancer and need treatment for the double cancer
- Requires treatment as shown in "Unacceptable Combination / Supportive Therapy" during the clinical trial period
- Have a medical history of severe hypersensitivity to immune checkpoint inhibitors or immune-related adverse events requiring treatment
- Have one of the following complications
- Complication of cerebrovascular disorder with symptoms or history within 6 months before the enrollment
- Active gastrointestinal perforation, fistula, diverticulitis
- Symptomatic congestive heart failure
- Bleeding tendency
- Presence of blood clots that may cause embolism on the image
- Unhealed fractures (excluding compression fractures associated with osteoporosis) or severe wounds requiring medical treatment
- Uncontrollable digestive ulcer
- Active infectious diseases requiring intravenous administration of antibiotics, antifungal agents or antiviral agents
- HIV antibody positive
- At the time of the enrollment, the period from the following prior treatment or the end of treatment has not passed.
- 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
- Scheduled thoracotomy or abdominal surgery during the clinical trial period
- It is judged that it is difficult to enroll in this study due to clinically significant mental illness.
- Pregnant women, lactating women, women who are currently pregnant, or have no intention of contraception for 4 months after consent is obtained.
- Allergic to antibiotics and foreign animal-derived ingredients (pig and mouse)
- Difficult to participate in the trial by the investigator
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05438459
Start Date
June 8 2022
End Date
March 31 2029
Last Update
November 18 2025
Active Locations (1)
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1
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582