New hope for advanced stomach cancer: experimental drug LM-302 enters final testing phase
NCT ID NCT06351020
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug called LM-302 against standard treatments for people with advanced stomach or gastroesophageal junction cancer that has gotten worse after at least two prior therapies. The trial includes 387 adults whose tumors have a specific protein (CLDN18.2) and are HER2-negative. The main goals are to see if LM-302 helps people live longer or slows cancer growth compared to the doctor's choice of standard treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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387 people
The number who actually took part.
- Started
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Jun 2024
- Expected to finish
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Dec 2026
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 to 80 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: * Age 18-80 years old, male and female * Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC). * Has received and progressed on at least 2 lines of systemic therapy. A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy. * Centrally confirmed CLDN18.2-positive * HER2 negative * At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1) * ECOG: 0-1 * Expected survival ≥12 weeks; * Good blood reserve and liver, kidney and coagulation function * Willing to provide informed consent for study participation. Exclusion Criteria: * Within the first 5 years of randomization, there is a history of malignant tumors other than GC/GEJ adenocarcinoma, except for skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, and skin squamous cell carcinoma that have been cured and cured after treatment * Individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation * Urine protein qualitative result ≥ 3+, or urine protein qualitative result is 2+and 24-hour urine protein quantification\>1g * Individuals with a history of severe cardiovascular and cerebrovascular diseases * Individuals who are unable to control or have serious illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks prior to initial medication, interstitial pneumonia/lung disease requiring intervention during screening, and tumor related pain requiring local treatment during screening * Current peripheral sensory or motor neuropathy ≥ grade 2 * Uncontrollable third space effusion in clinical practice * Received or planned to undergo major surgery or intervention during the study period within the first 28 days of randomization * The researcher determined that there are other situations that are not suitable 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.
Contacts and locations
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000, China
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Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000, China
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