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New drug combo aims to slow stomach cancer progression

NCT ID NCT07432295

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests whether adding the experimental drug givastomig to standard immunotherapy and chemotherapy can help people with advanced stomach or esophageal cancer live longer without their cancer growing. About 180 adults whose tumors have certain proteins (CLDN18.2 and PD-L1) will receive either the new combo or standard treatment alone. Researchers will track side effects and how long the cancer stays under control.

What this could mean

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

Active substance
givastomig (a targeted antibody) combined with nivolumab (immunotherapy) and chemotherapy
What this could lead to
If it works, this could point toward a more effective first-line treatment for people with advanced stomach or esophageal cancer that expresses certain proteins.
What could go wrong
This is an early Phase 2 trial with only 180 participants, so results may not apply to everyone. Adding a new drug also raises unknown side effect risks.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

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

Started

Feb 2026

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: * Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC). * Treatment-naïve for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy allowed if ≥6 months since last dose). * CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells). * PD-L1 positive (CPS ≥1). * At least 1 measurable lesion per RECIST v1.1. * ECOG performance status 0 or 1. * Adequate organ function, including: * Hematologic: WBC ≥2,000/μL; ANC ≥1,500/μL; platelets ≥100,000/μL; hemoglobin ≥9 g/dL * Hepatic: AST/ALT ≤3×ULN (≤5×ULN if liver metastases); bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's) * Renal: Creatinine ≤1.5×ULN or eGFR ≥50 mL/min/1.73 m² * Life expectancy ≥90 days. * Women of childbearing potential (WOCBP) and men must use effective contraception during the study and for a defined period after treatment. * Willing and able to provide informed consent and comply with study procedures Exclusion Criteria: * HER2-positive tumors. * Second malignancy within 3 years, except certain skin or cervical cancers. * Active or unstable gastrointestinal ulcer or bleeding within 6 weeks. * Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy. * Active pneumonitis or history requiring steroids/immunosuppressive therapy within 3 years. * Participation in another therapeutic clinical trial. * Major surgery or significant injury within 4 weeks prior to first dose, or planned major surgery within 6 months. * Radiotherapy within protocol-specified timeframes without adequate recovery. * Active CNS metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable). * Significant cardiovascular disease (NYHA Class 3-4 CHF, recent MI, unstable angina, TIA/stroke, or major cardiac procedures within 6 months). * Active or uncontrolled HIV, hepatitis B, or hepatitis C infection, or immunodeficiency (controlled infection allowed). * Receipt of live vaccine within 30 days or other vaccines within 7 days of first dose. * Active infection requiring parenteral therapy. * Known hypersensitivity to study drug components (e.g., DPD deficiency). * Any other condition or laboratory abnormality that, in the investigator's judgment, increases risk or interferes with study participation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    6 sites in 3 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

  • I-MAB Site 1005

    RECRUITING

    Duarte, California, 91010, United States

  • I-Mab Site - 4001

    NOT_YET_RECRUITING

    Kashiwa, Japan

  • I-Mab Site 1002

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • I-Mab Site 1016

    RECRUITING

    Goodyear, Arizona, 85338, United States

  • I-Mab Site 2001

    RECRUITING

    Beijing, China

  • I-Mab Site 4005

    RECRUITING

    Tokyo, Japan

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