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

Kyushu University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Gastric Cancer; Pancreatic Cancer

Treatments: Biological: Phase I part; Biological: Phase II part

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05438459

CTR024-001

Details and patient eligibility

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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. 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

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)
   • eGFR >=30mL/min/1.73m2

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

GAIA-102 as a monotherapy

Experimental group

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.

Treatment:

Biological: Phase II part

Biological: Phase I part

GAIA-102 and pembrolizumab in combination

Experimental group

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.

Treatment:

Biological: Phase II part

Biological: Phase I part