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NCT05438459

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

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved 3 years 3 months later, primary endpoint(s) modified.

See at-risk trials from Kyushu University

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Mar 31, 2032 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 101 words
    • Enrollment increased: 130 → 176 participants
    • Interventions modified
    • Trial arms changed: 3 → 6
    • Secondary endpoints: 12 to 11
    • Collaborators: 7 to 2
  2. Primary completion date: Dec 31, 2026 to Dec 31, 2028v4 Show 6 more changesShow less
    • Eligibility criteria expanded, about 80 words
    • Primary endpoints: 3 to 4
    • Enrollment target: 96 to 130
    • Study completion date: Jun 8, 2027 to Mar 31, 2029
    • Secondary endpoints: 11 to 12
    • Study arms: 2 to 3
  3. Eligibility criteria expanded, about 6 words
    • Collaborators: 6 to 7
    v3
  4. Eligibility criteria expanded, about 17 words
    • Primary endpoints: 2 to 3
    • Site details revised
    • Collaborators expanded, about 21 words
    v2
  5. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Number of participants of Dose Limiting Toxicity (DLT) with GAIA-102 (Phase I)
Timeframe: Cycle 1 (Cycle period is 28 days)
Frequency and severity of adverse events(Phase I)
Timeframe: 2 year
Overall survival in patients with gastric cancer (Phase II)
Timeframe: up to 4 years
Overall survival in patients with pancreatic cancer (PhaseⅡ)
Timeframe: up to 5 years(up to 5.5 years for the Run-in Cohort）

Secondary (11)

Objective Response Rate （ORR) and Disease Control Rate (DCR)(Phase I)
Progression-free Survival(Phase I)
Overall Survival Period(Phase I)
Pharmacokinetics of GAIA-102(Phase I)
Biomarker of GAIA-102(Phase I)
Show 6 moreShow less
Objective Response Rate and Disease Control Rate(Phase II)
Progression-free Survival (Phase II)
Objective Response Period and Period until Objective Response (Phase II)
One-year survival rate in patients (Phase II)
Frequency and severity of adverse events (Phase II)
Biomarker of GAIA-102(Phase II)

Arms and interventions

Phase I Monotherapy CohortExperimental

Participants receive GAIA-102 as monotherapy.

Phase I Combination CohortExperimental

Participants receive GAIA-102 in combination with pembrolizumab.

Phase II Gastric Cancer Part: GAIA-102 and Pembrolizumab Combination GroupExperimental

Participants receive GAIA-102 in combination with pembrolizumab.

Phase II Gastric Cancer Part: Ttrifluridine/tipiracil hydrochloride (FTD/TPI)Control GroupActive comparator

Participants receive trifluridine/tipiracil hydrochloride (FTD/TPI).

Phase II Pancreatic Cancer Part:GAIA-102 and Pembrolizumab Added to Standard Therapy GroupExperimental

Participants receive GAIA-102 in combination with pembrolizumab, irinotecan hydrochloride hydrate, calcium levofolinate hydrate, and fluorouracil.

Phase II Pancreatic Cancer Part:Standard Therapy GroupActive comparator

Participants receive standard therapy consisting of irinotecan hydrochloride hydrate, calcium levofolinate hydrate, and fluorouracil.

Biologicals: GAIA-102

Drugs: Pembrolizumab, Trifluridine/tipiracil hydrochloride (FTD/TPI), Irinotecan hydrochloride hydrate, Calcium levofolinate hydrate, Fluorouracil

Sites

1 site in 1 country

  • Kyushu University HospitalFukuoka, Fukuoka, Japan