New drug cocktail aims to shrink stomach tumors before surgery
NCT ID NCT07581574
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing a combination of two drugs—trastuzumab rezetecan and retlirafusp alfa—in 12 people with HER2-positive stomach or gastroesophageal junction cancer. The treatment is given before surgery to see if it can safely shrink tumors. The main focus is on safety and finding the right dose, with secondary goals like how many patients have no cancer left after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trastuzumab rezetecan (antibody-drug conjugate) and retlirafusp alfa (immunotherapy drug)
- What this could lead to
- If this works, it could point toward a more effective pre-surgery treatment for HER2-positive gastric cancer, potentially improving tumor shrinkage and long-term outcomes.
- What could go wrong
- This is a very early, small phase 1b trial with only 12 participants and no control group. The main goal is safety, so it's too soon to know if the combo truly helps. Side effects from the drugs are possible.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 75 years
- 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: * Voluntary Participation: The subject voluntarily agrees to participate in this study, is able to sign the informed consent form (ICF), and has good compliance. * Age and Gender: Aged 18 to 75 years (at the time of signing the ICF), regardless of gender. * Diagnosis and Staging: Histologically and/or cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma. Diagnosed as locally advanced according to the AJCC 8th Edition criteria, with cTNM staged as T3-4N+M0 based on endoscopic ultrasound or contrast-enhanced CT/MRI scans (combined with diagnostic laparoscopy if necessary). The subject must agree to undergo radical surgery, and the investigator assesses the lesion as potentially resectable. * Treatment History: No prior systemic therapy for the current disease, including anti-tumor radiotherapy, chemotherapy, or immunotherapy. * HER2 Status: Confirmed HER2 IHC 3+ or HER2 IHC 2+ with positive FISH result based on endoscopic biopsy tissue IHC results. * Biomarker Status: PD-L1 CPS ≥1, EBV-positive, or dMMR/MSI-H; at least one of the three criteria must be met. * Performance Status: ECOG score of 0-1. * Life Expectancy: Estimated life expectancy ≥6 months. * Organ Function: Adequate major organ function * Contraception and Pregnancy: Subjects of childbearing potential must use appropriate contraception methods during the study and for 120 days after the end of the study. Serum pregnancy test must be negative within 7 days prior to study enrollment, and the subject must not be breastfeeding. Exclusion Criteria: * Other Malignancies: Concomitant malignant diseases other than gastric cancer (excluding early-stage tumors that have been radically cured). * Bleeding Risk: Tumor lesions with a tendency to bleed (e.g., active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months prior to signing the ICF, or judged by the investigator to be at risk of massive gastrointestinal bleeding) or have received blood transfusion therapy within 4 weeks prior to the administration of the study drug. * Concurrent Studies: Currently participating in other interventional drug clinical studies, or have received other investigational drugs or investigational device therapy within 4 weeks prior to the first dose. * Prior Therapies: Previous exposure to the following therapies: anti-HER2, anti-PD-1, anti-PD-L1 agents, anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.). * Autoimmune Disease: Active autoimmune disease that required systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Note: The use of physiological doses of corticosteroids (≤10 mg/day prednisone or equivalent) is permitted. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment. * Prior Medication: Received systemic treatment with Traditional Chinese Medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukins, excluding local use for pleural effusion control) within 2 weeks prior to the first dose. * Transplant History: Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation. * Allergy: Known hypersensitivity to the drugs used in this study. * Neuropathy: Peripheral neuropathy ≥ Grade 2. * HIV Infection: Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV 1/2 antibody positive). * Hepatitis: Subjects with active Hepatitis B or Hepatitis C. * Vaccination: Received live vaccines within 30 days prior to the first dose (Cycle 1, Day 1). Note: Inactivated virus vaccines for seasonal influenza (injection) are permitted within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted. * Pregnancy/Lactation: Pregnant or breastfeeding women. * Uncontrolled Systemic Disease: Presence of any severe or uncontrolled systemic disease. * Patients with mental disorders who are unable to cooperate with treatment; * Other: Any history or evidence of disease, treatment, or abnormal laboratory values that may interfere with trial results or hinder the subject's full participation in the study, or other conditions deemed by the investigator to pose potential risks or make the subject unsuitable for participation in this study.
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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.
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The places running it
1 site. 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
Locations
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First Affiliated Hospital of Nanjing Medical Unviersity
Nanjing, Jiangsu, 210000, China
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Other studies related to the condition(s) this trial covers.
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