A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours

Launched by LANOVA MEDICINES LIMITED · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new medication called LM-168, both on its own and in combination with another drug called toripalimab, for patients with advanced solid tumors. The main goals of the study are to determine how safe LM-168 is, find out the best dose to use, and see if it can help shrink tumors. The trial is divided into two phases: the first phase focuses on safety and dosage, while the second phase looks at how effective the treatment is at reducing tumors.

To be eligible for this study, participants need to be at least 18 years old and have advanced solid tumors that have not responded to standard treatments. They must also be able to communicate well with the research team and have a life expectancy of at least three months. Participants should be in good overall health, meaning their organs and blood function properly, and they must agree to sign consent forms before starting. It’s important to know that the trial is not currently recruiting participants, but it will welcome individuals who meet these criteria once it begins. Participants will receive close monitoring during the study to ensure their safety.

Gender

ALL

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 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. In dose escalation stage, subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
• • 6. In dose expansion stage, subjects must have histological or cytological confirmation of selected advanced solid tumors.
• • 7. Pre-treatment archived tumour tissue or on-treatment tumour biopsy could be provided for biomarker analysis optionally.
• • 8. At least one measurable disease.
• • 9. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
• • 10. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.
• Exclusion Criteria:
• • 1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-168.
• • 2. Having received prior the same target or any other immunotherapy or immune-oncology (IO) agent within 28 days of commencing treatment with LM-168.
• • 3. Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-168.
• • 4. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
• • 5. Subjects with uncontrolled tumour-related pain.
• • 6. Subjects with known central nervous system (CNS) or meningeal metastasis.
• • 7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• • 8. Subjects with esophageal or gastric varices requiring immediate intervention, or those with a history of variceal bleeding.
• • 9. Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe liver cirrhosis.
• • 10. Tumor invasion of surrounding vital organs or a risk of developing esophagotracheal fistula or esophagopleural fistula.
• • 11. Patients with a history of active or previously confirmed inflammatory bowel disease.
• • 12. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
• • 13. Subjects who previously experienced grade ≥ 3 immune-related adverse events during immunotherapy, as well as subjects who discontinued prior immunotherapy due to severe or life-threatening immune-related adverse events.
• • 14. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-168.
• • 15. Subjects with the known history of autoimmune disease.
• • 16. Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia , drug-induced pneumonitis, idiopathic pneumonitis, interstitial lung disease, severe radiation pneumonitis or evidence of active pneumonitis on screening chest CT scan.
• • 17. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-168.
• • 18. Current or recent use of aspirin (\> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.
• • 19. Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for \> 2 weeks prior to the first dose of LM-168.
• • 20. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-168 (excluding tumour biopsy, puncture, etc.).
• • 21. Subjects who have severe cardiovascular disease.
• • 22. Subjects who have uncontrolled or severe illness.
• • 23. Subjects who have a history of immunodeficiency disease.
• • 24. HIV infection, active infection including tuberculosis, HBV and HCV infection.
• • 25. Subjects with a history of other malignancies within 5 years prior to the first administration of the study drug.
• • 26. Child-bearing potential female who have positive results in pregnancy test or are lactating.
• • 27. Subjects who have psychiatric illness or disorders that may preclude study compliance.
• • 28. Subject who is judged as not eligible to participate in this study by the investigator.