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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Administration of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination.
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.
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
RECRUITINGNumber 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
Time frame: Cycle 1 (Cycle period is 28 days)
Frequency and severity of adverse events(Phase I)
Time frame: 2 year
Overall survival period in patients with gastric cancer (Phase II)
Time frame: up to 4 years
One-year survival rate in patients with pancreatic cancer (PhaseⅡ)
Time frame: 1 year
Objective Response Rate (ORR) and Disease Control Rate (DCR)(Phase I)
Time frame: Week 24
Progression-free Survival(Phase I)
Time frame: 2 year
Overall Survival Period(Phase I)
Time frame: 2 year
Pharmacokinetics of GAIA-102(Phase I)
The following metrics were meassured as pharmcokinetics; Cmax: The peak plasma concentration of a drug after administration.; tmax. : Time to reach Cmax; Cmin: The lowest (trough) concentration that a drug reaches before the next dose is administered.
Time frame: pre-dose
Biomarker of GAIA-102(Phase I)
Protein expression levels are measured in ascites and blood as biomarkers. The following are the markers to be measured; CCL3/CCL4/CCL5/CCL20/CXCL9/CXCL10/CXCL11
Time frame: pre-dose
Objective Response Rate Disease Control Rate(Phase II)
Time frame: up to 4 years
Progression-free Survival (Phase II)
Time frame: up to 4 years
Objective Response Period and Period until Objective Response (Phase II)
Time frame: up to 4 years
One-year survival rate in patients with gastric cancer (Phase II)
Time frame: 1 year
Overall survival period in patients with pancreatic cancer (Phase II)
Time frame: up to 4 years
Frequency and severity of adverse events (Phase II)
Time frame: up to 4 years
Biomarker of GAIA-102(Phase II)
Protein expression levels are measured in ascites and blood as biomarkers. The following are the markers to be measured; CCL3/CCL4/CCL5/CCL20/CXCL9/CXCL10/CXCL11
Time frame: pre-dose
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