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

NCT05438459 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-11-18

No results posted yet for this study

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

Interventions

BIOLOGICAL

Phase I part

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

BIOLOGICAL

Phase II part

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.

Sponsors & Collaborators

  • GAIA BioMedicine Inc.

    collaborator INDUSTRY

  • Toho University - Omori Medical Center

    collaborator UNKNOWN

  • Jichi Medical University

    collaborator OTHER

  • Kindai University Hospital

    collaborator UNKNOWN

  • Teikyo University Hospital

    collaborator UNKNOWN

  • Kansai Medical University Hospital

    collaborator UNKNOWN

  • Kyushu Cancer Center

    collaborator UNKNOWN

  • Kyushu University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2028-12-31
Completion
2029-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05438459 on ClinicalTrials.gov