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

Part of paid clinical trials in Newark, Delaware.

Sponsor
AstraZeneca
Study ID
NCT07069712
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Gastroesophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sonesitatug Vedotin — DRUG
    Sonesitatug Vedotin will be administered as an IV infusion.
  • Rilvegostomig — DRUG
    Rilvegostomig will be administered as an IV infusion.
  • Trastuzumab Deruxtecan (T-DXd) — DRUG
    T-DXd will be administered as an IV infusion.
  • Capecitabine — DRUG
    Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.
  • 5-Fluorouracil (5-FU) — DRUG
    5-FU (Fluoropyrimidine) will be administered as a continuous IV infusion as chemotherapy standard of care.
  • FLOT Chemotherapy — DRUG
    FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
  • Calcium folinate — DRUG
    Calcium folinate will be administered as an IV infusion as chemotherapy standard of care.

Study Details

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.

Key Dates

First listed
Jul 17, 2025
Start date
Jul 17, 2025
Status verified
Aug 2026
Primary completion
Nov 3, 2027
Completion
Jul 16, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sub-study 1: Cohort 1a - Sonesitatug Vedotin plus Rilvegostomig and 5-FU or Capecitabine
    Participants will receive Sonesitatug Vedotin (Dose A) plus Rilvegostomig and 5-FU or Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose A) plus Rilvegostomig as adjuvant therapy 2.
  • Experimental: Sub-study 2: T-DXd plus Rilvegostomig and 5-FU or Capecitabine
    Participants will receive T-DXd plus Rilvegostomig and 5-FU or Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Rilvegostomig as adjuvant therapy 2.
  • Experimental: Sub-study 3: Rilvegostomig plus FLOT chemotherapy
    Participants will receive Rilvegostomig plus FLOT chemotherapy as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Rilvegostomig as adjuvant therapy 2.
  • Experimental: Sub-study 1: Cohort 1b - Sonesitatug Vedotin plus Rilvegostomig and Capecitabine
    Participants will receive Sonesitatug vedotin (Dose B) plus Rilvegostomig and Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose B) plus Rilvegostomig as adjuvant therapy 2.
  • Experimental: Sub-study 1: Cohort 1c - Sonesitatug Vedotin plus Rilvegostomig plus 5-FU and calcium folinate
    Participants will receive Sonesitatug Vedotin (Dose C) plus Rilvegostomig plus 5-FU and calcium folinate as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose C) plus Rilvegostomig as adjuvant therapy 2.

Primary Outcome Measure

Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Until sub-study completion, up to 38 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Research SiteNewarkDelaware19713-
Research SiteWashington D.C.District of Columbia20007-
Research SiteFairwayKansas66205-
Research SiteNorth ShoresMichigan49444-
Research SiteNew YorkNew York10032-
Research SiteNew YorkNew York10065-
Research SitePittsburghPennsylvania15232-

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