NCT06682780 A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
| NCT ID | NCT06682780 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | LaNova Medicines Limited |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2025-09-17 |
| Primary Completion | 2028-12-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 320 participants in total. It began in 2025-09-17 with a primary completion date of 2028-12-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 understand and adhere to the requirements of this study. Single-agent dose of 6mg/kg, 12mg/kg and and combined cohort：Subjects tested positive for biomarkers. Exclusion Criteria: 1. Previously received with same target therapy. 2. Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417. 3. Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc. 4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. 5. Poorly controlled tumor-related pain. 6. Subjects with symptomatic/active central nervous system (CNS)metastases. 7. Subject who have uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 8. Subjects with known hypersensitivity to antibody therapy; 9. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) for more than 7 days or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-2417. 10. Previous or current known autoimmune disease. 11. Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. 12. Use of any live vaccine or live attenuated vaccines within 28 days prior to the first dosing of LM-2417.; 13. Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists. 14. Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of LM-2417. 15. Subject who have history of severe cardiovascular disease. 16. Subjects who have uncontrolled or severe illness. 17. HIV infection, active HBV or HCV infection. 18. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening. 19. Child-bearing potential female who have positive results in pregnancy test or are lactating. 20. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial. 21. Subject who is judged as not eligible to participate in this study by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06682780 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06682780 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06682780 currently recruiting?
Yes, NCT06682780 is actively recruiting participants. Contact the research team at alexyuan@lanovamed.com for enrollment information.
Where is the NCT06682780 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06682780 clinical trial?
NCT06682780 is sponsored by LaNova Medicines Limited. The trial plans to enroll 320 participants.