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Recruiting Phase 1, Phase 2 NCT06682780

A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours

Trial Parameters

Condition Advanced Solid Tumor
Sponsor LaNova Medicines Limited
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 320
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-09-17
Completion 2028-12-25
Interventions
LM-2417DocetaxelToripalimab/Tirelizumab

Brief Summary

This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.

Eligibility Criteria

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) , male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Life expectancy ≥ 3 months. 5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy. 6. Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing. 7. At least one evaluable lesion. 8. Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose. 9. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug. 10. Subjects who can communicate well with investigators and unde

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