Ignite Creation Date:
2024-05-06 @ 8:19 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02716012
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-27
First Post:
2016-03-11
Brief Title:
First-in-Human Safety Tolerability and Antitumour Activity Study of MTL-CEBPA in Patients With Advanced Liver Cancer
Sponsor:
Mina Alpha Limited
Organization:
Mina Alpha Limited
Study Overview
Official Title:
A First-in-Human Multi-centre Open-label Phase 1ab Clinical Study With RNA Oligonucleotide Drug MTL-CEBPA to Investigate Its Safety Tolerability and Antitumour Activity in Patients With Advanced Liver Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
OUTREACH
Brief Summary:
MNA-3521-011 study is a multi-centre open-label first-in-human phase 1ab clinical study dosedose frequency escalation followed by a cohort expansion part MTL-CEBPA is administered as monotherapy or in combination with sorafenib to patients with advanced hepatocellular carcinoma and cirrhosis of the liver All participants will be considered unsuitable for liver tumour resection andor is refractory to radiotherapy and other loco-regional therapies
MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES liposomal nanoparticle and is designed to activate the CEBPA gene
MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES liposomal nanoparticle and is designed to activate the CEBPA gene
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2015-003051-21 | EUDRACT_NUMBER | None | None |
| 20332 | OTHER | UK NIHR CRN | None |