RecruitingPhase 1NCT06587295

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

A Phase 1, Open-Label, Dose Escalation and Expansion Study of Intramuscular ACM-CpG Monotherapy in Patients With Advanced/Metastatic Solid Tumors With Prior Response to Immunotherapy Alone or in Combination With Chemotherapy

Sponsor

National Cancer Centre, Singapore

Enrollment

40 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Metastatic Solid Tumor

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

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Intramuscular ACM-CpG Monotherapy (Escalation) and a drug called Intramuscular ACM-CpG Monotherapy (Expansion) for people with advanced solid tumor and metastatic solid tumor. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntramuscular ACM-CpG Monotherapy (Escalation)

Dose escalation for ACM-CpG monotherapy administered via intramuscular injection will similarly be conducted using traditional 3+3 dose escalation. Three dose levels have been planned. If the patient experiences a DLT or two Grade ≥ 2 drug-related toxicity, the dose level will be expanded according to a 3+3 design. The safety and tolerability of each dose level will be assessed by the study team after all patients enrolled in the dose level have been followed for at least 21 days after the first dose of the ACM-CpG (DLT observation period). Once the MTD is reached, the RP2D will be determined.

DRUGIntramuscular ACM-CpG Monotherapy (Expansion)

Patients will be administered ACM-CpG monotherapy at a dose determined in the dose escalation phase.