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

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.

Trial Details

NCT ID
NCT05438459
Phase
PHASE1 / PHASE2
Sponsor
Kyushu University
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Phase I part
  • Phase II part
Locations (sample)
  • Fukuoka, Fukuoka, Japan|33.6,130.41667

Key Eligibility Criteria

  • Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or adv…
  • Patients with gastric cancer who have received 3 or more prior chemotherapy regimens and are refractory or intolerant to these therapies, and patie…
  • Patients with gastric cancer who have received 2 or more prior chemotherapy regimens, including at least 1 regimen containing an immune checkpoint …
  • Abdominal port placement is possible

For full eligibility, visit ClinicalTrials.gov.

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