MC# 22-14 - A Phase I/II, Open-Label, Dose Escalation and Expansion 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 Pembrolizumab in Advanced Solid Tumors
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Agent(s): LM-108
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Disease Type(s): Solid Tumor
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Phase(s): I, II
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Drug Classification(s): Immunotherapy, Monoclonal Antibody, Targeted Therapy
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Molecular Target(s): CCR8
Mechanism of Action
LM-108 is a monoclonal antibody that is designed to bind to CCR8. It is thought to target Tumor-Infiltrating T Regulatory cells for depletion by enhancing an antibody-dependent cellular cytotoxicity mechanism.
Purpose
In this study, the sponsor and investigators want to learn:
- How much of LM-108 can be given with an acceptable level of side effects alone and in combination with pembrolizumab
- The effects of LM-108 (good and bad) alone and in combination with pembrolizumab
- How much of LM-108 is absorbed into the blood and how fast it is removed
- If the body’s immune system has a response to LM-108 alone and in combination with pembrolizumab
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- 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
- At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
- Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose
Exclusion Criteria
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
- Uncontrolled tumour-related pain
- Known central nervous system (CNS)
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Use of inhaled corticosteroids
- Known history of autoimmune disease
- Use of any live attenuated vaccines within 28 days
- Have severe cardiovascular disease
- Uncontrolled or severe illness
- History of immunodeficiency disease
- Active malignancies which are likely to require the treatment.
- Child-bearing potential female
- Have psychiatric illness or disorders
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
