Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05086692
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2021-09-10
Brief Title:
A Beta-only IL-2 ImmunoTherapY Study
Sponsor:
Medicenna Therapeutics Inc
Organization:
Medicenna Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Open Label Dose Escalation and Expansion Study of MDNA11 IL-2 Superkine Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABILITY-1
Brief Summary:
This is a Phase 12 multi-center open-label dose-escalation and expansion study to evaluate safety and tolerability PK pharmacodynamic and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors
Detailed Description:
The study drug MDNA11 long-acting beta-only recombinant interleukin-2 rIL-2 MDNA11 specifically engineered to overcome the shortcomings of rhIL-2 aldesleukin by preferentially activating immune effector cells CD8 T- and NK cells responsible for killing cancer cells with minimal or no stimulation of immunosuppressive Tregs It is designed to potentially enhance host immune response and fusion to albumin increases the half-life further avoiding frequent dosing required with rhIL-2
The study will be conducted at up to 30 clinical sites following regulatory authority and institutional review board independent ethics committee IRB IEC approval and completion of informed consent The study will be conducted in multiple parts
Monotherapy MDNA11 alone dose escalation
Monotherapy MDNA11 alone dose expansion in select tumor types
Combination MDNA11 pembrolizumab dose escalation
Combination MDNA11 pembrolizumab dose expansion in select tumor types
Approximately 115 patients will be enrolled
After commencing treatment first exposure of MDNA11 alone or MDNA11 pembrolizumab tumor assessment by CTMRI will be performed every 8 weeks 1 week until immune confirmed progressive disease iCPD by iRECIST discontinuation of study drugs withdrawal of consent or loss to follow-up Treatment beyond progression may be permitted if criteria are met Patients can withdraw from participation at any time
The study will be conducted at up to 30 clinical sites following regulatory authority and institutional review board independent ethics committee IRB IEC approval and completion of informed consent The study will be conducted in multiple parts
Monotherapy MDNA11 alone dose escalation
Monotherapy MDNA11 alone dose expansion in select tumor types
Combination MDNA11 pembrolizumab dose escalation
Combination MDNA11 pembrolizumab dose expansion in select tumor types
Approximately 115 patients will be enrolled
After commencing treatment first exposure of MDNA11 alone or MDNA11 pembrolizumab tumor assessment by CTMRI will be performed every 8 weeks 1 week until immune confirmed progressive disease iCPD by iRECIST discontinuation of study drugs withdrawal of consent or loss to follow-up Treatment beyond progression may be permitted if criteria are met Patients can withdraw from participation at any time
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KEYNOTE-E53 | OTHER | None | None |
| MK3475-E53 | OTHER | Merck Sharp Dohme LLC | None |