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Gastroesophageal AdenocarcinomaCancerDrugPhase 2

What this study is

GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.

What's being tested

  • Sonesitatug Vedotin

    Intervention · DRUG

    Sonesitatug Vedotin will be administered as an IV infusion.

  • Rilvegostomig

    Intervention · DRUG

    Rilvegostomig will be administered as an IV infusion.

  • Trastuzumab Deruxtecan (T-DXd)

    Intervention · DRUG

    T-DXd will be administered as an IV infusion.

  • Capecitabine

    Intervention · DRUG

    Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.

  • 5-Fluorouracil (5-FU)

    Intervention · DRUG

    5-FU (Fluoropyrimidine) will be administered as a continuous IV infusion as chemotherapy standard of care.

  • FLOT Chemotherapy

    Intervention · DRUG

    FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.

  • Calcium folinate

    Intervention · DRUG

    Calcium folinate will be administered as an IV infusion as chemotherapy standard of care.

Study details

Official title
A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)
Sponsor
AstraZeneca
Conditions
Gastroesophageal Adenocarcinoma
Enrolling
100 people
Starts
2025-07-17
Est. completion
2029-07-16
Design
Open-label, non-randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗