A study of novel agents or combinations as perioperative treatment in participants with locally advanced resectable gastroesophageal adenocarcinoma
Study identifier:D9804C00001
ClinicalTrials.gov identifier:NCT07069712
EudraCT identifier:N/A
CTIS identifier:2024-516909-23-00
Recruiting
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)
Medical condition
Gastroesophageal Adenocarcinoma
Phase
Phase 2
Healthy volunteers
No
Study drug
Sonesitatug Vedotin, Rilvegostomig, Trastuzumab Deruxtecan (T-DXd), Capecitabine, 5-Fluorouracil (5-FU), FLOT Chemotherapy, Calcium folinate
Sex
All
Estimated Enrollment
100
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 17 Jul 2025
Estimated Primary Completion Date: 03 Nov 2027
Estimated Study Completion Date: 16 Jul 2029
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2026 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
PAREXEL
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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. | Drug: Sonesitatug Vedotin Sonesitatug Vedotin will be administered as an IV infusion. Other Name: AZD0901 Drug: Rilvegostomig Rilvegostomig will be administered as an IV infusion. Other Name: AZD2936 Drug: Capecitabine Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care. Drug: 5-Fluorouracil (5-FU) 5-FU (Fluoropyrimidine) will be administered as a continuous IV infusion as chemotherapy standard of care. |
| 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. | Drug: Rilvegostomig Rilvegostomig will be administered as an IV infusion. Other Name: AZD2936 Drug: Trastuzumab Deruxtecan (T-DXd) T-DXd will be administered as an IV infusion. Other Name: DS-8201a Drug: Capecitabine Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care. Drug: 5-Fluorouracil (5-FU) 5-FU (Fluoropyrimidine) will be administered as a continuous IV infusion as chemotherapy standard of care. |
| 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. | Drug: Rilvegostomig Rilvegostomig will be administered as an IV infusion. Other Name: AZD2936 Drug: FLOT Chemotherapy FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion. |
| 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. | Drug: Sonesitatug Vedotin Sonesitatug Vedotin will be administered as an IV infusion. Other Name: AZD0901 Drug: Rilvegostomig Rilvegostomig will be administered as an IV infusion. Other Name: AZD2936 Drug: Capecitabine Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care. |
| 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. | Drug: Sonesitatug Vedotin Sonesitatug Vedotin will be administered as an IV infusion. Other Name: AZD0901 Drug: Rilvegostomig Rilvegostomig will be administered as an IV infusion. Other Name: AZD2936 Drug: 5-Fluorouracil (5-FU) 5-FU (Fluoropyrimidine) will be administered as a continuous IV infusion as chemotherapy standard of care. Drug: Calcium folinate Calcium folinate will be administered as an IV infusion as chemotherapy standard of care. Other Name: Leucovorin |
