MedTrace Logo

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

NCT06587295 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-20

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Interventions

DRUG

Intramuscular 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.

DRUG

Intramuscular ACM-CpG Monotherapy (Expansion)

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

Sponsors & Collaborators

  • ACM Biolabs

    collaborator INDUSTRY

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Dr Amit Jain, MBBS, MRCP (UK), MMed · National Cancer Centre, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06587295 on ClinicalTrials.gov