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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1 / Phase 2

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

90 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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. Child-bearing potential female who have positive results in pregnancy test or are lactating.
11. Participants who have psychiatric illness or disorders that may preclude study compliance.
12. Participants who is judged as not eligible to participate in this study by the investigator.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Other measures

Research locations (7)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

7 locations

Study team and timeline

Lead sponsor

LaNova Medicines Limited

Study start

Oct 20, 2026 Actual

Primary completion

Oct 19, 2030 Estimated

Study completion

Aug 19, 2031 Estimated

First posted

Sep 29, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.