Actively Recruiting
Intramuscular ACM-CpG Monotherapy in Patients With Advanced/Metastatic Solid Tumors With Prior Response to Immunotherapy Alone or in Combination With Chemotherapy
Led by National Cancer Centre, Singapore · Updated on 2025-03-20
40
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
N
National Cancer Centre, Singapore
Lead Sponsor
A
ACM Biolabs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Intramuscular ACM-CpG Monotherapy in Patients With Advanced/Metastatic Solid Tumors With Prior Response to Immunotherapy Alone or in Combination With Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 21 years of age or older at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no decline in function over the past 2 weeks
- Estimated life expectancy greater than 12 weeks
- Confirmed terminal, Stage 4, advanced or metastatic solid tumors with prior clinical response to immune checkpoint inhibitors alone or with chemotherapy (complete response, partial response, or stable disease) and now disease progression
- Adequate blood counts without recent use of growth factors or transfusions
- Liver function with AST and ALT at or below 3 times upper limit of normal and total bilirubin at or below 5 times upper limit of normal (exceptions for Gilbert's Syndrome and controlled hepatitis B or C)
- Adequate kidney function with creatinine clearance ≥ 30 mL/min or serum creatinine less than 1.5 times upper limit of normal
- Coagulation tests within specified limits, with exceptions for patients on Warfarin
- Previous antitumor therapies stopped at least 4 weeks or 5 half-lives before ACM-CpG treatment; symptom relief radiation completed at least 2 weeks prior
- Prior adverse events, including immune-related events, improved to baseline or acceptable grade levels
- Female participants of childbearing potential must have negative pregnancy test and agree to effective contraception during and for 26 weeks after treatment
- Male participants must agree to use adequate contraception during and for 26 weeks after treatment
You will not qualify if you...
- Use of granulocyte colony stimulating factors, erythropoietin, or blood transfusions within 14 days before first dose
- Uncontrolled active infections or poorly controlled diabetes, asthma, or COPD
- Known HIV infection unless clinically controlled
- Primary immunodeficiency or autoimmune disorders requiring treatment
- Major surgery within 4 weeks before first dose
- Pregnant or nursing individuals
- Prior organ transplantations or allogeneic stem cell transplants
- Significant heart conditions including recent myocardial infarction or uncontrolled heart disease
- Recent pulmonary embolism or deep vein thrombosis within 3 months
- Live viral vaccine therapy within 4 weeks before first dose
- History of illicit substance abuse
- Other significant medical or psychiatric illnesses that could affect safety or study integrity
- Use of systemic corticosteroids above 10 mg daily prednisolone equivalent, except topical, ophthalmological, or inhalational steroids
- Active immunosuppression exceeding allowed steroid dose requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Centre, Singapore
Singapore, Singapore, 168583
Actively Recruiting
Research Team
D
Dr Amit Jain, MBBS, MRCP (UK), MMed
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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