Testing LM-101 Injection for Advanced Malignant Tumors

A Phase I/II, Open-label, Dose Escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of LM-101 Injection as a Single Agent or Combination Therapy in Patients With Advanced Malignant Tumors

This study is testing a new injection called LM-101 to see if it is safe and effective for people with advanced malignant tumors, both on its own and with other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 139 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: LaNova Medicines Limited (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 5 sites (Guangzhou, Guangdong and 4 other locations)
• Trial ID: NCT05615974 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of LM-101 injection in patients with advanced malignant tumors. It aims to determine the Maximum Tolerated Dose (MTD) and the recommended phase 2 dose (RP2D) of LM-101, both as a standalone treatment and in combination with other therapies like Toripalimab and Rituximab. Participants will be closely monitored for their response and any adverse effects throughout the treatment process.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with recurrent or refractory advanced solid tumors who have progressed on standard therapy.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignant tumors who have not responded to standard therapies.

How similar studies have performed: Other studies involving similar approaches have shown promise, but the specific combination of LM-101 with these agents is novel.

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.

Where this trial is running

Guangzhou, Guangdong and 4 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• Linyi Cancer Hospital — Linyi, Shandong, China (Not_yet_recruiting)
• Beijing Tongren Hospital, CMU — Beijing, China (Terminated)
• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Alex Yuan

Conditions Malignant Tumors