GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites

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)

Sponsors

Lead Sponsor: Kyushu University

Source Kyushu University
Brief Summary

Phase I Part : Confirm the safety of GAIA-102 GAIA-102 as a single agent 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 single agent 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.

Overall Status Recruiting
Start Date 2022-06-08
Completion Date 2027-06-08
Primary Completion Date 2026-12-31
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of participants of Dose Limiting Toxicity (DLT) with GAIA-102 (Phase I) Cycle 1 (Cycle period is 28 days)
Progression Free Survival (PFS) rate at 6 months (Phase II) Week 24
Secondary Outcome
Measure Time Frame
Objective Response Rate (ORR) and Disease Control Rate (DCR)(Phase I) Week 24
Progression-free Survival(Phase I) 2 year
Overall Survival(Phase I) 2 year
Pharmacokinetics of GAIA-102(Phase I) pre-dose
Biomarker of GAIA-102(Phase I) pre-dose
Objective Response Rate Disease Control Rate(Phase II) 2 year
Progression-free Survival (Phase II) 2 year
Objective Response Period and Period until Objective Response (Phase II) 2 year
Overall Survival (Phase II) 2 year
Frequency and severity of adverse events (Phase II) 2 year
Biomarker of GAIA-102(Phase II) pre-dose
Enrollment 96
Condition
Intervention

Intervention Type: Biological

Intervention Name: Phase I part

Description: Administration of GAIA-102 as a single agent or GAIA-102 and pembrolizumab in combination.

Intervention Type: Biological

Intervention Name: Phase II part

Description: Randomized into group of administration of GAIA-102 as a single agent or GAIA-102 or pembrolizumab in combination, group of standard treatment

Eligibility

Criteria:

Inclusion Criteria: 1. Unresectable, advanced and relapsed gastric cancer with malignant ascites or unresectable, advanced and relapsed pancreatic cancer with malignant ascites 2. Refractory/intolerant to more than 3 regimens of therapy for gastric cancer (more than 2 regimens acceptable for Phase II) or more than 2 regimens of therapy for pancreatic cancer (more than 1 regimen acceptable for Phase II) 3. Abdominal port placement is possible 4. No medical history of serious side effects or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort) 5. Diagnosed gastric adenocarcinoma or pancreatic cancerwith by histological or cytological examination 6. Negative (MSS= not MSI-high) by microsatellite instability test 7. Eastern Cooperative Oncology Group (ECOG) Performance status(PS) 0-2 8. Patient aged 20years or older 9. 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) - Serum creatinine <=1.5mg/dL - CCr >=30mL/min 10. Expected to survive for 3 months or more at the enrollment 11. Written informed consent Exclusion Criteria: 1. Untreated cranial metastases. 2. Diagnosed with meningeal carcinomatosis 3. Received allogeneic hematopoietic stem cell transplantation 4. 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. 5. Existence or suspected active autoimmune disease 6. 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 7. 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. 8. Have active double cancer and need treatment for the double cancer 9. Requires treatment as shown in "Unacceptable Combination / Supportive Therapy" during the clinical trial period 10. Have a medical history of severe hypersensitivity to immune checkpoint inhibitors or immune-related adverse events requiring treatment 11. 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 12. 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 13. Scheduled thoracotomy or abdominal surgery during the clinical trial period 14. It is judged that it is difficult to enroll in this study due to clinically significant mental illness. 15. Pregnant women, lactating women, women who are currently pregnant, or have no intention of contraception for 4 months after consent is obtained. 16. Allergic to antibiotics and foreign animal-derived ingredients (pig and mouse) 17. Difficult to participate in the trial by the investigator

Gender:

All

Minimum Age:

20 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Eiji Oki

Phone: +81-92-642-5479

Email: [email protected]

Location
Facility: Status: Contact: Kyushu University Hospital Eiji Oki +81-92-642-5479 [email protected]
Location Countries

Japan

Verification Date

2022-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Kyushu University

Investigator Full Name: EijiOki

Investigator Title: Lecturer

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: GAIA-102 as a single agent

Type: Experimental

Description: 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.

Label: GAIA-102 and pembrolizumab in combination

Type: Experimental

Description: 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. Pembrolizumab:200 mg on Day 1.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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