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OncoMatch/Clinical Trials/NCT06587295

Intramuscular ACM-CpG Monotherapy in Patients With Advanced/Metastatic Solid Tumors With Prior Response to Immunotherapy Alone or in Combination With Chemotherapy

Is NCT06587295 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Intramuscular ACM-CpG Monotherapy (Escalation) and Intramuscular ACM-CpG Monotherapy (Expansion) for advanced solid tumor.

Phase 1RecruitingNational Cancer Centre, SingaporeNCT06587295Data as of May 2026

Treatment: Intramuscular ACM-CpG Monotherapy (Escalation) · Intramuscular ACM-CpG Monotherapy (Expansion)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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Disease stage

Required: Stage IV

Metastatic disease required

Stage 4, advanced or metastatic solid tumors

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: immunotherapy

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

Lab requirements

Blood counts

ANC ≥ 1.5 ×10^9/L (no G-CSF within 2 weeks), platelets ≥ 100 × 10^9/L (no transfusion within 2 weeks), hemoglobin ≥ 9 g/dL (no transfusion or erythropoietin within 2 weeks)

Kidney function

creatinine clearance ≥ 30 mL/min (Cockcroft-Gault) or serum creatinine < 1.5 × ULN

Liver function

AST and ALT ≤ 3 × ULN, total bilirubin ≤ 5 × ULN. Exception: Gilbert's Syndrome or familial benign unconjugated hyperbilirubinemia. Hepatitis B and C carriers eligible if liver function within specifications, HBV DNA low, HCV RNA negative, and adequate disease control on antiviral therapy.

Adequate hematologic function...AST and ALT ≤ 3 × ULN, total bilirubin ≤ 5 × ULN...creatinine clearance ≥ 30 mL/min or serum creatinine < 1.5 × ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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