ACM-CpG is a CpG-B TLR9 agonist, which in animal models has led to shrinkage and complete disappearance of injected tumors, durable antitumor memory, and growth inhibitory effects on non-injected tumors while intramuscular administration led to durable control of tumors. This Phase I trial will assess the safety and early signs of efficacy of intramuscular injection of ACM-CpG in patients with advanced malignant solid tumors.
The overall objectives of this trial are to establish the safety ACM-CpG.
≥ 21 years of age at the time of informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no functional deterioration over the previous 2 weeks.
Estimated life expectancy of more than 12 weeks.
Patients with terminal, Stage 4, advanced or metastatic solid tumors, confirmed histologically or pathologically documented, and who have previously received and clinically responded to ICI alone or in combination chemotherapy with best response by RECIST 1.1 being complete response (CR), partial response (PR) or stable disease (SD) who now have progression of disease and have previously received existing standard of care treatment.
Patients receiving granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), erythropoietin, or blood (red blood cell [RBC] or platelet) transfusion within 14 days prior to the first dose of the study drug.
Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled diabetes as evidenced by screening (baseline) Hb1Ac ≥7.5, asthma, chronic obstructive pulmonary disease (COPD).
Known positive test result for human immunodeficiency virus (HIV) (except the disease is clinically controlled) or acquired immune deficiency syndrome (AIDS).
Patients with any type of primary immunodeficiency or autoimmune disorder requiring treatment.
National Cancer Centre, Singapore
Lead sponsor
ACM Biolabs
Collaborator