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NCT Number: NCT07069712

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

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.

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Key information

Conditions

Gastroesophageal Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Toronto, Ontario, Canada

Loading trial locations.

About this study

This Phase II, open-label, multi-drug, multi-center platform study consists of individual sub-studies, each allows the assessment of multiple novel agents or novel combinations.

Participants will be assigned across 3 sub-studies, to have sufficient evaluable participants of the confirmed recommended dose by Safety Review Committee (SRC) for study intervention in each corresponding sub-study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
  • Participants who are CLDN18.2-positive and HER2-negative 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

Treatment and study plan

AZD0901

Drug

AZD0901 will be administered as an IV infusion.

Other names: Sonesitatug Vedotin

Rilvegostomig

Drug

Rilvegostomig will be administered as an IV infusion.

Other names: AZD2936

Trastuzumab Deruxtecan (T-DXd)

Drug

T-DXd will be administered as an IV infusion.

Other names: DS-8201a

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 an 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.

Primary outcomes

  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Until sub-study completion, up to 38 months

    To assess the safety and tolerability of perioperative treatment.

  2. Percentage of participants with pathological complete response (pCR)

    Time frame: Until sub-study completion, up to 38 months

    pCR is defined as no viable cancer cells, including lymph nodes after complete evaluation in the resected gastric, GEJ, or esophageal cancer specimen and all sampled regional lymph nodes following neoadjuvant treatment.

Secondary outcomes

  1. Surgery completion rate as planned

    Time frame: Until sub-study completion, up to 38 months

    Surgery completion rate (including R0 and R1) as planned is defined as the percentage of participants who received intended gastrectomy or gastroesophagectomy as planned.

  2. R0 resection (complete resection) rate as planned

    Time frame: Until sub-study completion, up to 38 months

    R0 resection (complete resection) rate as planned is the percentage of participants who received gastrectomy or gastroesophagectomy and had a confirmed margin-negative resection as planned.

  3. Percentage of participants with tumor downstaging

    Time frame: Until sub-study completion, up to 38 months

    Tumor downstaging is defined as the lowering of the primary tumor (T) and/or regional lymph nodes (N) from pre-neoadjuvant clinical staging (pre-cTN) to post-neoadjuvant clinical staging (post-cTN) and to postoperative pathological staging (ypTN).

  4. Event-free survival (EFS)

    Time frame: Until sub-study completion, up to 38 months

    EFS is defined as the time from the first dose of study intervention to documented Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or non-RECIST 1.1 disease progression that precludes radical surgery or requires non-protocol therapy during the neoadjuvant through surgery period, or to documented RECIST 1.1 or biopsy-confirmed non-RECIST 1.1 recurrence or progression of disease during the adjuvant period, or death due to any cause at any time.

  5. Disease-free survival (DFS)

    Time frame: Until sub-study completion, up to 38 months

    DFS is defined as the time elapsed from the date of the first post-surgery scan (ie, Adjuvant Baseline scan) until the date of first evidence of disease recurrence as determined by Investigator using RECIST 1.1 assessment (local or distant), or death due to any cause, whichever occurs first.

  6. Objective response rate (ORR)

    Time frame: Until sub-study completion, up to 38 months

    ORR is defined as the percentage of participants who have a CR or PR as determined by Investigator using RECIST 1.1 at their latest assessment prior to surgery.

  7. Overall survival (OS)

    Time frame: Until sub-study completion, up to 38 months

    OS is defined as the time from the first dose of the study intervention until the date of death due to any cause regardless of whether participant withdraws from treatment or receives another anti-cancer therapy.

  8. Serum concentrations of study interventions

    Time frame: Until sub-study completion, up to 38 months

    To assess the serum concentrations of study interventions in participants receiving perioperative treatment.

  9. Number of participants with positive anti-drug antibodies (ADA)

    Time frame: Until sub-study completion, up to 38 months

    To assess the immunogenicity of study interventions in participants receiving perioperative treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 17, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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