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

NCT05438459 | Recruiting Phase 1 DMC

• 1 other identifier: CTR024-001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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 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

Gastric Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• Number of participants of Dose Limiting Toxicity (DLT) with GAIA-102 (Phase I)

  DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and is defided following events: 1. Grade 4 hemotoxicity or hemotoxicity requiring blood transfusion. 2. Grade 3 or higher non-hematoxicity

  Cycle 1 (Cycle period is 28 days)

• Frequency and severity of adverse events(Phase I)

  2 year

• Overall survival period in patients with gastric cancer (Phase II)

  up to 4 years

• One-year survival rate in patients with pancreatic cancer (PhaseⅡ)

  1 year

Secondary Outcomes (12)

• Objective Response Rate （ORR) and Disease Control Rate (DCR)(Phase I)

  Week 24

• Progression-free Survival(Phase I)

  2 year

• Overall Survival Period(Phase I)

  2 year

• Pharmacokinetics of GAIA-102(Phase I)

  pre-dose

• Biomarker of GAIA-102(Phase I)

  pre-dose

Study Arms (3)

GAIA-102 as a monotherapy

EXPERIMENTAL

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.

Biological: Phase I part; Biological: Phase II part

GAIA-102 and pembrolizumab in combination

EXPERIMENTAL

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.

Biological: Phase I part; Biological: Phase II part

Ttrifluridine/tipiracil hydrochloride (FTD/TPI) as the standard therapy group

EXPERIMENTAL

Trifluridine/tipiracil hydrochloride (FTD/TPI) : Trifluridine/tipiracil hydrochloride (FTD/TPI) will be administered orally twice daily for 5 consecutive days, followed by a 2-day rest period. This cycle will be repeated twice, followed by a 14-day rest period. One course consists of this schedule, and the treatment will be repeated in cycles.

Biological: Phase II part

Interventions

Phase I part BIOLOGICAL

Administration of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination.

GAIA-102 and pembrolizumab in combination; GAIA-102 as a monotherapy

Phase II part BIOLOGICAL

Patients will be randomly assigned to receive either GAIA-102 monotherapy or GAIA-102 in combination with pembrolizumab at the recommended dosing regimen confirmed in the Phase I part, or to receive standard therapy. For patients with gastric cancer, the standard therapy group will receive trifluridine/tipiracil hydrochloride (FTD/TPI) only.

GAIA-102 and pembrolizumab in combination; GAIA-102 as a monotherapy; Ttrifluridine/tipiracil hydrochloride (FTD/TPI) as the standard therapy group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyushu University: lead
• GAIA BioMedicine Inc.: collaborator
• Toho University - Omori Medical Center: collaborator
• Jichi Medical University: collaborator
• Kindai University Hospital: collaborator
• Teikyo University Hospital: collaborator
• Kansai Medical University Hospital: collaborator
• Kyushu Cancer Center: collaborator

Study Sites (1)

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Eiji Oki

CONTACT

+81-92-642-5479; oki.eiji.857@m.kyushu-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 30, 2022
• Study Start: June 8, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

JP (1)