A Phase I/II, Open-Label, Dose Escalation and Expansion Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Advanced Solid Tumors

LM108-01-102

A Phase I/II, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Pembrolizumab in Advanced Solid Tumors

2022-05-26

2023-10-06

2023-10-06

Terminated

Early phase I

24

Key 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 Key Exclusion Criteria: 1. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0 2. Uncontrolled tumour-related pain 3. Known central nervous system (CNS) 4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures 5. Use of inhaled corticosteroids 6. Known history of autoimmune disease 7. Use of any live attenuated vaccines within 28 days 8. Have severe cardiovascular disease 9. Uncontrolled or severe illness 10. History of immunodeficiency disease 11. Active malignancies which are likely to require the treatment. 12. Child-bearing potential female 13. Have psychiatric illness or disorders Note: Other protocol defined Inclusion/Exclusion criteria may apply.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-10-25