Study of LM-108 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours

• Status: Not yet recruiting
• Trial end date: 2025-10-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I/II, open-Label, dose-Escalation and dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 (an Anti-CCR8 mAb) as a Single Agent or in combination with Toripalimab in Advanced Solid Tumours.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LaNova Medicines Limited

Criteria

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

2. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.

3. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.

4. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.

Exclusion Criteria:

1. Have received anti-CCR8 drug treatment or other clinical study drug or treatment not on the market within 28 days prior to the first dose.

2. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-108, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.

3. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.

4. Subjects with uncontrolled tumor-related pain.

5. Subjects with known brain metastases.

6. Uncontrollable clinical third luminal effusion.

7. Known history of autoimmune disease.

8. Use of any live attenuated vaccines within 28 days.

9. Have severe cardiovascular disease.

10. Uncontrolled or severe illness.

11. History of immunodeficiency disease.

12. Active malignancies which are likely to require the treatment.

13. Child-bearing potential female.

14. Have psychiatric illness or disorders.