NCT05615974 A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors
| NCT ID | NCT05615974 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | LaNova Medicines Limited |
| Condition | Malignant Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 139 participants |
| Start Date | 2023-01-11 |
| Primary Completion | 2027-01-11 |
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 139 participants in total. It began in 2023-01-11 with a primary completion date of 2027-01-11.
⚠ 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 Maximum Tolerated Dose (MTD) and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors
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, 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, and have progressed on standard therapy. 6. At least one evaluable lesion. 7. Subjects in the combination therapy group must have Archived Samples or fresh tumor tissue specimens are required for testing. 8. Subjects must show appropriate organ and marrow function in laboratory 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. Exclusion Criteria: 1. Subject has received prior investigational therapy directed at the same target therapy. 2. Subjects has participated in any other interventional clinical trial within 21 days prior to the first dosing of LM-101. 3. Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-101, 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. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 8. Subjects with known hypersensitivity to antibody therapy. 9. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medicationswithin 2 weeks prior to the first dosing of LM-101. 10. Subjects with the known history of autoimmune disease with the exception of subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone. 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 attenuated vaccines within 28 days prior to the first dosing of LM-101. 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 within 28 days prior to the first dosing of LM-101 (excluding tumor biopsy, puncture, etc.). 15. Subjects who have history of severe cardiovascular disease. 16. Subjects who have uncontrolled or severe illness. 17. Subjects who have a history of immunodeficiency disease. 18. HIV infection, active tuberculosis or active HBV and HCV infection. 19. Subjects who have Known history of active tuberculosis. 20. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening. 21. Child-bearing potential female who have positive results in pregnancy test or are lactating. 22. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial. 23. Subject who is judged as not eligible to participate in this study by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05615974 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Tumors. 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 NCT05615974 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 NCT05615974 currently recruiting?
Yes, NCT05615974 is actively recruiting participants. Contact the research team at alexyuan@lanovamed.com for enrollment information.
Where is the NCT05615974 trial being conducted?
This trial is being conducted at Guangzhou, China, Wuhan, China, Linyi, China, Beijing, China and 1 additional location.
Who is sponsoring the NCT05615974 clinical trial?
NCT05615974 is sponsored by LaNova Medicines Limited. The trial plans to enroll 139 participants.