> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-lm-302-combination-with-other-anti-tumor-therapies-phase-f867e7b8-f10d-4281-8491-ff6441459c77 > Record changed: 2026-10-13 # A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study NCT05934331 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) Participants 276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) Lead sponsor LaNova Medicines Zhejiang Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) Start date 2023-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Title and summary **Summary** This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Short title** A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Official title** An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of the LM-302 Combination With Other Anti-tumor Treatment in Subjects With CLDN18.2-positive Advanced Gastro-Intestinal Cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Dates **Completion date** 2028-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **First posted** 2023-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Registry last updated** 2025-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Primary completion date** 2026-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Start date** 2023-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Size and sites **Participants** 276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Planned participants** 276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Lead sponsor** LaNova Medicines Zhejiang Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Identifiers **Registry ID** NCT05934331 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **ClinicalTrials.gov ID** NCT05934331 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Outcomes ### Primary outcomes 1. PFS Timeframe: 112 weeks Progression free survival according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) ### Secondary outcomes 1. ORR Timeframe: 112 weeks Objective response rate (ORR) 2. DOR Timeframe: 112 weeks Duration of response (DOR) 3. DCR Timeframe: 112 weeks Disease control rate (DCR = CR + PR + SD) 4. OS Timeframe: 112 weeks Overall survival (OS) 5. AEs Timeframe: 112 weeks Incidence of adverse events 6. SAEs Timeframe: 112 weeks Incidence of serious adverse events 7. Temperatures Timeframe: 112 weeks Temperatures 8. Pulse in BPM Timeframe: 112 weeks Beat per Minute 9. Blood Pressure Timeframe: 112 weeks Blood Pressure in mmHg 10. Weight Timeframe: 112 weeks Weight in Kg 11. Height Timeframe: 112 weeks Height in centimeter 12. Blood Routine examination Timeframe: 112 weeks Laboratory tests-Blood Routine examination 13. Urine Routine test Timeframe: 112 weeks Laboratory tests-Urine Routine test 14. Blood biochemistry Timeframe: 112 weeks Laboratory tests-Blood biochemistry 15. Coagulation function Timeframe: 112 weeks Laboratory tests- Coagulation function 16. LVEF Timeframe: 112 weeks Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage 17. HR Timeframe: 112 weeks 12-lead electrocardiogram (ECG) in HR 18. RR Timeframe: 112 weeks 12-lead electrocardiogram (ECG) in RR 19. PR Timeframe: 112 weeks 12-lead electrocardiogram (ECG) in PR 20. QRS Timeframe: 112 weeks 12-lead electrocardiogram (ECG) in QRS 21. QT Timeframe: 112 weeks 12-lead electrocardiogram (ECG) in QT 22. QTcF Timeframe: 112 weeks 12-lead electrocardiogram (ECG) in QTcF 23. ECOG score Timeframe: 112 weeks Eastern Cooperative Oncology Group score 24. PK Parameter:Cmax Timeframe: 112 weeks Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) 25. PK Parameter：Tmax Timeframe: 112 weeks PK Parameter:Time of Maximum Observed Concentration (Tmax) And 11 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### Inclusion criteria 1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure. 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 1. Subjects with known HER2-positive gastric cancer/adenocarcinoma of the gastroesophageal junction 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Sites - Shanghai East HospitalShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934331) ## Related records ### Drugs (9) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Gimeracil](https://trialight.com/data/asset/gimeracil-c6721c9d-7d42-4068-8b71-6afa2501a8e4.md) - [Nivolumab](https://trialight.com/data/asset/nivolumab-d2e207ca-a7d1-43d0-987f-43ef7eef8f1b.md) - [Oteracil](https://trialight.com/data/asset/oteracil-6bad6a40-4113-4f92-a2ce-1fd23fc478de.md) - [Rivoceranib](https://trialight.com/data/asset/rivoceranib-77932dd2-2af1-44e3-ba1a-24c963386df3.md) - [Tecotabart vedotin](https://trialight.com/data/asset/tecotabart-vedotin-cfec8ae4-22b5-4c2d-acd6-6c09fae4e2c8.md) - [Tegafur](https://trialight.com/data/asset/tegafur-373c07a7-2961-4c06-af1a-16fedfad4fd1.md) - [Toripalimab](https://trialight.com/data/asset/toripalimab-92e6b353-a6c4-4e1e-a99f-559038ba7177.md) ### Lead sponsors (1) - [LaNova Medicines Zhejiang Co., Ltd.](https://trialight.com/data/company/lanova-medicines-zhejiang-co-ltd-f7d9e140-d991-4ab3-9593-693f4ac45e28.md) ### Targets (18) - [DPYD](https://trialight.com/data/target/dpyd-350a1314-e4c8-5e4a-969a-7dd0aed96548.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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