A Study of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors

A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors

For Phase I, to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors.

For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.

Inclusion Criteria:

1. Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
2. Participants must be ≥18 years or the legal age of consent at the time of signing the ICF.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Life expectancy ≥ 3 months.
5. Adequate organ and bone marrow function as defined by protocol.
6. Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion Criteria:

1. Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364.
2. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0.
3. Participants with uncontrolled tumour-related pain.
4. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364.
5. Participants who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-364.
6. Participants who have severe cardiovascular disease.
7. Participants who have uncontrolled or severe illness.
8. Participants who have a history of immunodeficiency disease.
9. Participants with a known history of autoimmune disease.
10. Participants who have other active malignancies which are likely to require the treatment.
11. Child-bearing potential female who have positive results in pregnancy test or are lactating.
12. Participants who have psychiatric illness or disorders that may preclude study compliance.
13. Participants who is judged as not eligible to participate in this study by the investigator.