Recruiting
Phase 2

Novel Agents

Sponsor:

AstraZeneca

Code:

NCT07069712

Conditions

Gastroesophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sonesitatug Vedotin

Rilvegostomig

Trastuzumab Deruxtecan (T-DXd)

Capecitabine

5-Fluorouracil (5-FU)

Study Details

Brief summary:

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.

Conditions

Gastroesophageal Adenocarcinoma

Study ID

NCT07069712

Start date

Jul 17, 2025

Status verified date

Oct, 2026

Completion date

Jul 16, 2029

Anticipated

Primary completion date

Nov 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Sonesitatug Vedotin

Sonesitatug Vedotin will be administered as an IV infusion.

Rilvegostomig

Rilvegostomig will be administered as an IV infusion.

Trastuzumab Deruxtecan (T-DXd)

T-DXd will be administered as an IV infusion.

Capecitabine

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

5-Fluorouracil (5-FU)

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

FLOT Chemotherapy

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

Calcium folinate

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

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 ]
  • Percentage of participants with pathological complete response (pCR) [ Time Frame: Until sub-study completion, up to 38 months ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Newark, Delaware, United States, 19713

Research Site

Recruiting

Washington D.C., District of Columbia, United States, 20007

Research Site

Recruiting

Fairway, Kansas, United States, 66205

Research Site

Recruiting

North Shores, Michigan, United States, 49444

Research Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Research Site

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Research Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

AstraZeneca

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Locally Advanced Resectable Gastroesophageal Adenocarcinoma
  • Gastroesophageal Junction
  • Neoadjuvant Treatment
  • Perioperative Treatment
  • Gastric cancer
  • Immune checkpoint inhibitors
  • Chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.