Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 3interventionalRules rewrite

Phase 3: testing ASP2138 for Gastric Adenocarcinoma

Claudin 18.2 or CLDN18.2 is a protein found on cells in the digestive system. Researchers are looking at ways to attack CLDN18.2 to help control tumors.

Official registry: https://clinicaltrials.gov/study/NCT07673887 · Astellas Pharma Global Development, Inc. · enrollment listed as 570

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ASP2138, Pembrolizumab, or Oxaliplatin. The registry lists allocation as randomized. Claudin 18.2 or CLDN18.2 is a protein found on cells in the digestive system.

They plan to enroll about 570 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: ASP2138, Pembrolizumab, Oxaliplatin, Capecitabine, Folinic acid, 5-FU, Placebo for ASP2138, Placebo for Pembrolizumab

Primary outcome (registry wording): Overall Survival (OS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Participant has histologically or cytologically confirmed gastric or GEJ adenocarcinoma
  • Participant has radiographically confirmed, locally advanced unresectable or metastatic disease within 28 days prior to randomization
  • Participant has predicted life expectancy \>= 12 weeks
  • Female participant is not pregnant and at least 1 of the following conditions apply:
  • Not a women of childbearing potential (WOCBP)
  • Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period, and at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention
  • Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention

Public study contact (from the registry)

Astellas Pharma Global Development Inc

800-888-7704

Astellas.registration@astellas.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

12 listed

+ 11 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07673887 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07673887?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07673887?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary