A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
NCT ID: NCT05934331
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
276 participants
INTERVENTIONAL
2023-07-27
2028-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.
NCT06351020
A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)
NCT03281369
Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping
NCT06881017
Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors
NCT06947291
The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
NCT06587425
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LM-302 in combination with Toripalimab
LM-302
Q2W/Q3W，Administered intravenously
Toripalimab
Q2W/Q3W,Administered intravenously
LM-302 in combination with other therapies
LM-302
Q2W/Q3W，Administered intravenously
Toripalimab
Q2W/Q3W,Administered intravenously
Capecitabine
BID,Oral Administration
Tegafur, Gimeracil and Oteracil Potassium Capsules
BID,Oral Administration
Nivolumab
Q4W,Administered intravenously
Apatinib
QD,Oral Administration
Gemcitabine
Q4W,Administered intravenously
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LM-302
Q2W/Q3W，Administered intravenously
Toripalimab
Q2W/Q3W,Administered intravenously
Capecitabine
BID,Oral Administration
Tegafur, Gimeracil and Oteracil Potassium Capsules
BID,Oral Administration
Nivolumab
Q4W,Administered intravenously
Apatinib
QD,Oral Administration
Gemcitabine
Q4W,Administered intravenously
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Aged 18-80 years old (including boundary values) .
3. Eastern Cooperative Oncology Group (ECOG) performance status of0-1.
4. Life expectancy ≥ 3 months.
5. Subjects with advanced gastrointestinal tumors diagnosed histologically and/or cytologically and who have failed or are intolerant to prior standard first-line therapy (imaging confirmation required)
6. CLDN18.2-positive subjects.
7. At least one measurable lesion.
8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
9. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.
Exclusion Criteria
2. Subjects have participated in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).
3. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of IMP.
4. Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis. (for cohorts treated with combination PD-1).
5. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
6. Present peripheral sensory or motor neuropathy ≥ grade 2.
7. Subjects with uncontrolled pain.
8. Subjects with symptomatic/active central nervous system(CNS)metastases.
9. Subject who have uncontrollable third space effusion.
10. Subjects with known hypersensitivity to antibody therapy.
11. Subjects have treated with the same target.
12. Subjects have received Strong inhibitor/strong inducer of CYP3A4 within 14 days prior to first dose.
13. Use of any live vaccines within 28 days prior to 1st dosing of IMP.
14. Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.
15. Subjects on anticoagulants, such as heparin and vitamin K antagonists.
16. Clinically uncontrollable persistent recurrent vomiting.
17. Uncontrollable/severe gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP.
18. Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of IMP.
19. Subjects who have other cancers, other than the one treated in this trial, within 2 years prior to screening.
20. Subjects who have severe cardiovascular disease.
21. Subjects who have uncontrolled or severe illness.
22. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of IMP.
23. Subjects with a known history of autoimmune diseases.
24. Subjects who have a history of immunodeficiency disease.
25. Subjects with HIV infection, active HBV or HCV infection.
26. Child-bearing potential female who have positive results in pregnancy test within 7 days before the first dose or are lactating.
27. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
28. Subject who is judged as not eligible to participate in this study by the investigator.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LaNova Medicines Zhejiang Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jin Li
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital
Jieer Ying
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Haiping Jiang
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University
Rushen Zhao
Role: PRINCIPAL_INVESTIGATOR
Zibo Municipal Hospital
Chunmei Bai
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Hongming Pan
Role: PRINCIPAL_INVESTIGATOR
Sir Run Run Shaw Hospital
Jing Dai
Role: PRINCIPAL_INVESTIGATOR
Zhongnan Hospital
Yiping Mou
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial People's Hospital
Haijiao Yan
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Changzhou
Aiping Zhou
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Xianglin Yuan
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Yabin Xia
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Wannan Medical College
Mingzhu Huang
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Lixin Wan
Role: PRINCIPAL_INVESTIGATOR
Nanyang Central Hospital
Jun Zhou
Role: PRINCIPAL_INVESTIGATOR
Shanghai Gaobo Cancer Hospital
Youwei Zhang
Role: PRINCIPAL_INVESTIGATOR
Xuzhou Central Hospital
Ning Wu
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pudong New District Gongli Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai East Hospital
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jin Li
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LM302-02-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.