Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-27 @ 9:08 PM
Study NCT ID:
NCT06587295
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2024-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
The overall objectives of this trial are to establish the safety ACM-CpG.
Detailed Description:
This is a phase 1, open-label, dose escalation and expansion study of intramuscular ACM-CpG monotherapy in patients with advanced or metastatic solid tumours. Dose escalation will be conducted and the RP2D will be determined for ACM-CpG monotherapy for intramuscular routes of administration. The study will enroll patients who have received prior immunotherapy as standard of care treatment and have had demonstrable radiological responses.
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. The RP2D will be defined based on the observation of MTD in a dose level cohort, to include dose levels below the MTD, or intermediate between the pre-specified dose levels based on an overall assessment of all safety data, as well as all available PK and pharmacodynamic data, and documented objective response observations. RP2D will be a pharmacologically active dose, declared based on an aggregate of multiple factors including PK data evaluating the safety margin based on CpG7909 plasma concentrations across a range of dosing levels compared to prior data (https://pubmed.ncbi.nlm.nih.gov/17696823/) and clinical results.
Dose escalation and expansion will be performed in patients that have previously responded to immune checkpoint therapy alone or in combination with chemotherapy and who have already received standard of care treatment. Following the determination of the RP2D, dose expansion will be performed.
Approximately up to 30 to 40 patients will be enrolled on study.
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. The RP2D will be defined based on the observation of MTD in a dose level cohort, to include dose levels below the MTD, or intermediate between the pre-specified dose levels based on an overall assessment of all safety data, as well as all available PK and pharmacodynamic data, and documented objective response observations. RP2D will be a pharmacologically active dose, declared based on an aggregate of multiple factors including PK data evaluating the safety margin based on CpG7909 plasma concentrations across a range of dosing levels compared to prior data (https://pubmed.ncbi.nlm.nih.gov/17696823/) and clinical results.
Dose escalation and expansion will be performed in patients that have previously responded to immune checkpoint therapy alone or in combination with chemotherapy and who have already received standard of care treatment. Following the determination of the RP2D, dose expansion will be performed.
Approximately up to 30 to 40 patients will be enrolled on study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: