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New Dual-Action antibody could extend lives in stomach cancer

NCT ID NCT07700979

Disease control Sponsor: Akeso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding an experimental drug called cadonilimab to standard chemotherapy helps people with advanced stomach or gastroesophageal junction cancer live longer. Cadonilimab is a bispecific antibody that targets two immune checkpoints (PD-1 and CTLA-4) to boost the body's cancer-fighting response. The study compares this new combination against chemotherapy alone or with nivolumab, another immunotherapy. Participants have HER2-negative, previously untreated, unresectable or metastatic disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a bispecific antibody called cadonilimab that targets PD-1 and CTLA-4, combined with chemotherapy
What this could lead to
If successful, this could offer a new first-line treatment option for people with advanced gastric cancer, potentially improving survival.
What could go wrong
This is an early-stage trial, and the experimental drug may not prove more effective than existing treatments. Side effects from the combination therapy could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able to provide written informed consent and can understand and comply with the requirements of the study. 2. Histopathologically-confirmed diagnosis of locally advanced unresectable or metastatic G/GEJ adenocarcinoma. 3. No prior systemic therapy for locally advanced unresectable or metastatic G/GEJ adenocarcinoma. NOTE: For participants who have received prior neoadjuvant/adjuvant therapy for curative intent, the time between disease progression and last treatment should be at least 6 months. 4. ECOG PS of 0 or 1 within 3 days prior to randomization. 5. Age ≥ 18 years at the time of voluntarily signing informed consent. 6. Evaluable PD-L1 expression results. 7. Participants must have at least one measurable lesion per RECIST v1.1 as assessed by investigator assessment. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 8. Adequate organ function as indicated by the following laboratory values. Specimens must be collected within 7 days prior to the first dose of study treatment. 9. Life expectancy ≥3 months. 10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during treatment, and for at least 150 days after the last dose of cadonilimab/nivolumab, 270 days after the last dose of oxaliplatin, and 180 days after the last dose of capecitabine. 11. Non-sterile males must agree to use effective contraception during treatment and for at least 120 days following the last dose of cadonilimab/nivolumab/capecitabine and 180 days after the last dose of oxaliplatin. Exclusion Criteria: 1. Histopathologically confirmed other pathological types, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma. 2. Known HER2 positive. Be HER2-positive defined as either IHC 3+ or IHC 2+ in combination with ISH+ (or FISH). 3. Participants with active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. 4. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1 time/month). 5. Clinically significant bleeding symptoms within 28 days before the first dose or a definite tendency to bleed. 6. Have a history of ≥ Grade 2 gastrointestinal perforation and/or fistulae (including prior gastric fistula operation) within 6 months prior to randomization. 7. Participants who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric/gastroesophageal junction adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Baylor Scott & White Health

    Dallas, Texas, 75246, United States

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, China

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Guangdong Provincial People's Hospital

    Guangzhou, China

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w Warszawie

    Warsaw, Poland

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Peking University Cancer Hospital, Gastrointestinal Cancer Center I

    Beijing, China

  • Peking University Cancer Hospital, Gastrointestinal Oncology

    Beijing, China

  • Pratia MCM Kraków

    Krakow, Poland

  • Pratia Poznań

    Poznan, Poland

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute (SCRI) - Oncology Partners

    Nashville, Tennessee, 37203, United States

  • UCLA Health

    Los Angeles, California, 90095, United States

  • Univerity Marburg

    Marburg, Germany

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, Germany

  • University Cancer Center Frankfurt

    Frankfurt, Germany

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Universitätsmedizin der Johannes Gutenberg-Universität

    Mainz, Germany

  • Yale School of Medicine

    New Haven, Connecticut, 06510, United States

  • Zhongshan Hospital Fudan University

    Shanghai, China

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