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New treatment option for Advanced Solid Tumor
Official title Intramuscular ACM-CpG Monotherapy in Patients With Advanced/Metastatic Solid Tumors With Prior Response to Immunotherapy Alone or in Combination With Chemotherapy
ClinicalTrials.gov ID: NCT06587295
What this study is testing
What is Intramuscular ACM-CpG Monotherapy (Escalation)?
Intramuscular ACM-CpG Monotherapy (Escalation) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 99
You may be able to join if
- ≥ 21 years of age at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no functional deterioration over the previous 2 weeks.
- Estimated life expectancy of more than 12 weeks.
- Patients with terminal, Stage 4, advanced or metastatic solid tumors, confirmed histologically or pathologically documented, and who have previously...
- Adequate hematologic function, defined by the following:
You likely can't join if
- Patients receiving granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), erythropoietin, or blood...
- Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled...
- Known positive test result for human immunodeficiency virus (HIV) (except the disease is clinically controlled) or acquired immune deficiency...
- Patients with any type of primary immunodeficiency or autoimmune disorder requiring treatment.
- Major surgery within 4 weeks prior to the first dose of the study drug.
- Pregnant or nursing
See the full eligibility criteria
- ≥ 21 years of age at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no functional deterioration over the previous 2 weeks.
- Estimated life expectancy of more than 12 weeks.
- 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...
- Adequate hematologic function, defined by the following:
- 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.
- Platelet count ≥ 100 × 10\ \ 9/L without transfusion within 2 weeks (≤ 14 days) prior to study treatment.
- Hemoglobin ≥ 9 g/dL without transfusion or erythropoietin within 2 weeks (≤ 14 days) prior to study treatment.
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), and total bilirubin ≤ 5 × ULN. Exception: Patients who have serum bilirubin increases due to documented underlying...
- Adequate renal function defined by either a creatinine clearance ≥ 30 mL/min (by Cockcroft- Gault formula) or serum creatinine (SCr) \< 1.5 × ULN
- Coagulation tests, defined by the following:
- Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
- International normalized ratio (INR) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 × ULN is acceptable for patients on Warfarin anticoagulation.
- Previous antitumor therapy (including endocrine, chemoradiotherapy/ radiotherapy, targeted therapy, or immunotherapy) stopped at least 4 weeks/5 half lives (whichever is shorter) prior to administration of ACM-CpG...
- Previous AEs including irAE, have been improved to baseline or Grade ≤ 1 NCI CTCAE v5.0 (except for patients with alopecia, neuropathy, now or other AEs deemed to be G2 but clinically well managed), and specifically...
- Female people of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test positive is positive or cannot be...
- Male people should agree to use adequate method of contraception starting with the first dose of study therapy through 26 weeks after the last dose of the study therapy. Abstinence is acceptable if this is the usual...
- Patients receiving granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), erythropoietin, or blood (red blood cell [RBC] or platelet) transfusion within 14 days prior...
- Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled diabetes as evidenced by screening (baseline) Hb1Ac ≥7.5, asthma, chronic...
- Known positive test result for human immunodeficiency virus (HIV) (except the disease is clinically controlled) or acquired immune deficiency syndrome (AIDS).
- Patients with any type of primary immunodeficiency or autoimmune disorder requiring treatment.
- Major surgery within 4 weeks prior to the first dose of the study drug.
- Pregnant or nursing
- Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation.
- Clinically significant cardiac conditions, including myocardial infarction within the last 6 months, uncontrolled angina, viral myocarditis, pericarditis, cerebrovascular accident, or other acute uncontrolled heart...
- Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
- Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.
- Any known, documented, or suspected history of illicit substance abuse.
- Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illness/condition, which in the judgment of the Investigator might compromise the safety of the...
- Patients with systemic disease requiring systemic pharmacologic doses of corticosteroids greater than 10 mg daily prednisolone (or equivalent) are excluded
- people who are currently receiving steroids at a dose of \<= 10 mg daily do not need to discontinue steroids prior to enrollment.
- people that require topical, ophthalmological, and inhalational steroids would not be excluded from the study.
- people who require active immunosuppression of greater than the steroid dose discussed above for any reason are excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.