Intramuscular ACM-CpG Monotherapy in Patients With Advanced/Metastatic Solid Tumors With Prior Response to Immunotherapy Alone or in Combination With Chemotherapy
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 21 years of age at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no functional deterioration over the previous 2 weeks. 3. Estimated life expectancy of more than 12 weeks. 4. 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. 5. Adequate hematologic function, defined by the following: 1. Absolute neutrophil count (ANC) ≥ 1.5 ×10\*\*9/L, without the use of granulocyte colony stimulating factor such as filgrastim within 2 weeks prior to study treatment. 2. Platelet count ≥ 100 × 10\*\*9/L without transfusion within 2 weeks (≤