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USClinicalTrials.govClinical trialPhase 2Recruiting

A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

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Official record

Identifier
NCT07069712
Recruiting locations

countries

United StatesCanadaChinaGeorgiaItalyJapanPolandSpainTaiwanTurkey (Türkiye)United Kingdom
Interventions studied
Sonesitatug VedotinRilvegostomigTrastuzumab Deruxtecan (T-DXd)Capecitabine5-Fluorouracil (5-FU)FLOT ChemotherapyCalcium folinate
Lead sponsor
AstraZeneca
Target enrolment
100 participants
Study type
INTERVENTIONAL
Phase
Phase 2
Status
Recruiting
First posted
Jul 17, 2025
Last updated on the registry
Sep 24, 2026
Age
18 Years
Sex
ALL
Study contact
The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.
Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
* Participants who are CLDN18.2-positive in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ and bone marrow function
* Body weight \> 35 kg

Exclusion Criteria:

* Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.
* Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment
* Central nervous system (CNS) pathology
* Uncontrolled infections
* Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis
* History of another primary malignancy
* Participants with any known or suspicious distant metastasis
* Uncontrolled hepatitis B and/or chronic or active hepatitis B
* Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention
Indexed under
Gastric Cancer