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A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 plus Chemotherapy (CAPOX or mFOLFOX6) with Pembrolizumab vs Placebo plus Chemotherapy with or without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524557-14-00
Enrollment
96
Registered
2026-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Brief summary

Dual endpoints: ● OS, defined as the time from the date of randomization until the documented date of death from any cause ● PFS, defined as the time from the date of randomization until the date of radiographic disease progression (per RECIST V1.1 by BICR) or death from any cause, whichever is earlier

Detailed description

● ORR per RECIST V1.1 by BICR ● DCR per RECIST V1.1 by BICR ● DOR per RECIST V1.1 by BICR, PFS per RECIST V1.1 by investigator assessment, ● ORR per RECIST V1.1 by investigator assessment ● DCR per RECIST V1.1 by investigator assessment ● DOR per RECIST V1.1 by investigator assessment, Safety and tolerability as evaluated by the following: AEs/SAEs, clinical laboratory tests, vital signs, ECGs, and ECOG performance status, Serum concentrations of ASP2138: Ctrough, Participant-reported symptomatic AEs using: ● FACIT-GP5 ● PRO-CTCAE, HRQoL using additional parameters as measured by EORTC QLQ-C30, EORTC QLQ-OG25 and EQ-5D-5L questionnaires, Frequency of ADA-positive participants against ASP2138

Interventions

DRUGGLUCOSE
DRUGPEMBROLIZUMAB
DRUGCalcium folinate "Kalceks"
DRUGopløsning
DRUGXeloda 150 mg film-coated tablets
DRUGSODIUM CHLORIDE
DRUGInjektionslösung

Sponsors

Astellas Pharma Global Development Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Dual endpoints: ● OS, defined as the time from the date of randomization until the documented date of death from any cause ● PFS, defined as the time from the date of randomization until the date of radiographic disease progression (per RECIST V1.1 by BICR) or death from any cause, whichever is earlier—

Secondary

MeasureTime frame
● ORR per RECIST V1.1 by BICR ● DCR per RECIST V1.1 by BICR ● DOR per RECIST V1.1 by BICR, PFS per RECIST V1.1 by investigator assessment, ● ORR per RECIST V1.1 by investigator assessment ● DCR per RECIST V1.1 by investigator assessment ● DOR per RECIST V1.1 by investigator assessment, Safety and tolerability as evaluated by the following: AEs/SAEs, clinical laboratory tests, vital signs, ECGs, and ECOG performance status, Serum concentrations of ASP2138: Ctrough, Participant-reported symptomatic AEs using: ● FACIT-GP5 ● PRO-CTCAE, HRQoL using additional parameters as measured by EORTC QLQ-C30, EORTC QLQ-OG25 and EQ-5D-5L questionnaires, Frequency of ADA-positive participants against ASP2138—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 24, 2026