Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06022029
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-08-15
Brief Title:
A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas
Sponsor:
OncoNano Medicine Inc
Organization:
OncoNano Medicine Inc
Study Overview
Official Title:
A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas
Status:
RECRUITING
Status Verified Date:
2024-07
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:
ON-5001
Brief Summary:
A phase 1 multicenter open label non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose MTD minimum effective dose MED andor recommended dose for expansion RDE of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas
Detailed Description:
This Phase 1 multi-center trial will consist of three parts monotherapy dose escalation combination therapy dose finding and combination therapy dose expansion exploring two doses in specific tumor indications Each dosing cycle of ONM-501 will be 21 days ONM 501 will be administered as intratumoral injections once per week for three weeks on Days 1 8 and 15 followed by three weeks without ONM-501 administration The monotherapy dose escalation will utilize an accelerated titration method
The combination agent will be administered according to standard protocol once every three weeks This phase will evaluate ONM-501 in combination with approved immune checkpoint inhibitor ICI cemiplimab Enrollment in this phase will follow a Rolling 6 or 60 methodology - up to 6 patients will be enrolled in a staggered format dose escalation of ONM-501 will be permitted
Once the recommended doses for expansion RDEs are determined for ONM-501 ICI combination or ONM-501 monotherapy the expansion phase of this study will be initiated The expansion phase will enroll patients in one to three indication-specific expansion cohorts
The combination agent will be administered according to standard protocol once every three weeks This phase will evaluate ONM-501 in combination with approved immune checkpoint inhibitor ICI cemiplimab Enrollment in this phase will follow a Rolling 6 or 60 methodology - up to 6 patients will be enrolled in a staggered format dose escalation of ONM-501 will be permitted
Once the recommended doses for expansion RDEs are determined for ONM-501 ICI combination or ONM-501 monotherapy the expansion phase of this study will be initiated The expansion phase will enroll patients in one to three indication-specific expansion cohorts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None