New drug combo aims to slow stomach cancer progression
NCT ID NCT07432295
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
6 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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I-MAB Site 1005
RECRUITINGDuarte, California, 91010, United States
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I-Mab Site - 4001
NOT_YET_RECRUITINGKashiwa, Japan
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I-Mab Site 1002
RECRUITINGBoston, Massachusetts, 02114, United States
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I-Mab Site 1016
RECRUITINGGoodyear, Arizona, 85338, United States
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I-Mab Site 2001
RECRUITINGBeijing, China
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I-Mab Site 4005
RECRUITINGTokyo, Japan
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