A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer

NCT07631000 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 26-102
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to find out whether adding cadonilimab to the usual chemotherapy approach is an effective and safe treatment for participants with locally advanced/resectable gastric cancer or gastroesophageal junction (GEJ) cancer

Conditions

Gastric Cancer; Gastroesophageal-junction Cancer

Keywords

Gastroesophageal-junction Cancer; Gastric Cancer; Memorial Sloan Kettering Cancer Center; 26-102

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS) rata

  To determine the 18-month event-free survival (EFS) rate in patients with locally advanced, resectable, HER2-negative gastric or GEJ adenocarcinoma treated with perioperative cadonilimab and FLOT chemotherapy

  18 months

Study Arms (1)

Participants with HER2-negative gastric or GEJ adenocarcinoma

EXPERIMENTAL

Participants will have locally advanced, resectable, HER2-negative gastric or GEJ adenocarcinoma

Drug: Cadonilimab

Interventions

Cadonilimab DRUG

Perioperative cadonilimab plus neoadjuvant chemotherapy

Participants with HER2-negative gastric or GEJ adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of providing signed informed consent.
• Age ≥18 years at time of informed consent.
• ECOG performance status (PS) of 0 or 1 at enrollment.
• Pathologically confirmed gastric or GEJ adenocarcinoma with T1 N+ M0 or T2-4 N0-3 M0 (per AJCC 8th edition) resectable disease deemed eligible for radical surgery. A diagnostic laparoscopy is strongly recommended to confirm M0 status.
• HER2-negative tumor (IHC 0, 1+, or IHC 2+ and FISH non-amplified).
• Adequate organ and marrow function as defined below:
• Hemoglobin ≥9.0 g/dL
• Absolute neutrophil count ≥1.5 x 109/L
• Platelet count ≥100 x 109/L
• Serum bilirubin ≤1.5 x upper limit of normal (ULN). Patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled.
• ALT and AST ≤2.5 x ULN
• Albumin ≥2.8g/dL (albumin infusion is not allowed within 14 days before the start of treatment)
• Measured creatinine clearance \>50 mL/min as determined by Cockcroft-Gault using actual body weight 7. Willing and able to undergo pre-treatment (during screening) and on-treatment tumor biopsies.
• \. Women of childbearing potential (as defined in Section 13.3) must have a negative serum pregnancy test within 72 hours prior to the first dose and agree to take effective contraception measures during the study drug administration and within 9 months after the last dose.
• \. Male patients with female partners of childbearing potential (as defined in Section 13.3) must agree to take effective contraception measures during the study drug administration and within 6 months after the last dose.

You may not qualify if:

• Histologies other than adenocarcinoma, including squamous/adenosquamous cell carcinoma, neuroendocrine, or GI stromal tumor.
• HER2-positive tumor (IHC 2+ and FISH-amplified, or IHC 3+).
• Prior anticancer treatment for the disease under study (chemotherapy, radiation therapy, chemoradiation, approved or investigational therapy) prior to initiation of study treatment.
• Prior receipt of an anti-PD1 or anti-CTLA4 monoclonal antibody, including for prior non-gastric malignancy.
• Underlying medical conditions that, in the Investigator's opinion, make the administration of cadonilimab hazardous, including but not limited to:
• Interstitial lung disease (ILD), including history of ILD or non-infectious pneumonitis.
• Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of initiation of cadonilimab with the exception of prophylactic antibiotic treatment.
• Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to initiation of study treatment, myocardial infarction within 6 months prior to initiation of study treatment, or unstable arrhythmia.
• A condition or unresolved AE from a prior investigational drug that may obscure interpretation of toxicity determination or AEs.
• History of prior solid-organ transplant, including allogeneic bone marrow transplant.
• Concurrent chronic medical condition requiring the use of supraphysiologic doses of corticosteroids (\>10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids not excluded).
• Any active autoimmune disease or documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma or atopy.
• Replacement therapy (e.g. insulin, levothyroxine) is not considered a form of systemic treatment.
• Participants with asthma who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections not excluded.
• Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome not excluded.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yelena Janjigian, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yelena Janjigian, MD

CONTACT

646-888-4286; janjigiy@mskcc.org

Daniela Molena, MD

CONTACT

212-639-3870; molenad@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): May 27, 2029
• Study Completion (Estimated): May 27, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (7)