First-in-Human Safety, Tolerability and Antitumour Activity Study of MTL-CEBPA in Patients With Advanced Liver Cancer
NCT ID: NCT02716012
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
75 participants
INTERVENTIONAL
2016-03-01
2025-07-31
Brief Summary
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MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES® liposomal nanoparticle and is designed to activate the CEBPA gene.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MTL-CEBPA Monotherapy
MTL-CEBPA administered weekly, twice weekly or thrice weekly over 3 weeks followed by 1 week of rest defining a 28-day cycle.
MTL-CEBPA
Intravenous administration
MTL-CEBPA & Sorafenib (combination)
MTL-CEBPA is administered weekly or twice weekly in combination with sorafenib over 3 weeks followed by 1 week of rest defining a 28-day cycle.
MTL-CEBPA
Intravenous administration
Sorafenib 200mg
Sorafenib tablets
MTL-CEBPA & Sorafenib (sequential)
MTL-CEBPA is administered weekly or twice weekly for 2 cycles (28-day cycle) followed by 2 cycles of sorafenib
MTL-CEBPA
Intravenous administration
Sorafenib 200mg
Sorafenib tablets
Interventions
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MTL-CEBPA
Intravenous administration
Sorafenib 200mg
Sorafenib tablets
Eligibility Criteria
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Inclusion Criteria
* Patient is considered unsuitable for liver tumour resection and/or is refractory to radiotherapy and other loco-regional therapies
* At least one measurable lesion with target lesion size ≥ 1.0 cm as measured by MRI or CT
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Child-Pugh class A or B (up to B7)
* Eligible to undergo pre and post treatment mandated biopsies
* Acceptable laboratory parameters, as demonstrated by:
* Platelets ≥ 70 x 10\^9/L
* Serum albumin \> 26 g/L
* ALT and AST ≤ 5 x ULN
* Bilirubin ≤ 50 µmol /L
* WBC ≥ 2.0 x 10\^9/L, Absolute neutrophil count ≥ 1.5 x 109/L
* Haemoglobin ≥ 9.0 g/dL
* Prothrombin time (PT) \<20 seconds
* Acceptable renal function as demonstrated by:
* Serum creatinine ≤ 1.5 x ULN
* Calculated creatinine clearance ≥ 60 mL/min
Exclusion Criteria
* Prior investigational drugs within the last 30 days
* Grade \> 1 prior treatment-related toxicities (excluding alopecia) at the time of screening
* Patients with clinically significant cancer ascites
* Any episode of bleeding from oesophageal varices or other uncontrolled bleeding within the last 3 months prior to study treatment initiation
* Patients with history of haemorrhage or gastrointestinal perforation
* Patients administered with serum albumin within the last 7 days prior to the first study drug administration
* Known infection with human immunodeficiency virus (HIV)
* Patients with central nervous system (CNS), bone or peritoneal metastasis
* Patients presenting with marked baseline prolongation of QT/QTc interval defined as repeated demonstration of a QTc interval ≥450 ms (males) and ≥460 ms (females) using Fridericia's correction formula
* Signs and symptoms of heart failure characterised as greater than the New York Heart Association (NYHA) Class I or other clinically significant cardiac abnormalities (including history of myocardial infarction) including stable abnormalities.
* Major surgery within the last 30 days prior to study treatment initiation
* Patients with history of organ transplantation or cardiac surgery
* Patients with sepsis, ineffective biliary drainage with or without cholangitis, obstructive jaundice or encephalopathy at screening visit or within the last two weeks prior to study treatment initiation, whichever earlier
* Evidence of spontaneous bacterial peritonitis or renal failure or allergic reactions to the agent or excipient at screening visit or within the last two weeks prior to study treatment initiation, whichever earlier
* Known hypersensitivity to the active sorafenib or to any of the excipients
* Occurrence of a grade 3 or higher sorafenib or lenvatinib related toxicity during any sorafenib / lenvatinib treatment received prior to study enrolment, according to toxicity criteria (NCI CTCAE v 5.0)
* Pregnant or lactating women
16 Years
ALL
No
Sponsors
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Mina Alpha Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Debashis Sarker, MBChB, MRCP
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust and King's College London
Professor Nagy Habib, FRCS
Role: STUDY_DIRECTOR
Mina Alpha Limited
Locations
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National University Hospital
Singapore, , Singapore
National Taiwan University Hospital
Taipei, , Taiwan
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Cambridge University Hospitals NHS Trust
Cambridge, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, , United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
The Royal Free London NHS Foundation Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Countries
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References
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Sarker D, Plummer R, Meyer T, Sodergren MH, Basu B, Chee CE, Huang KW, Palmer DH, Ma YT, Evans TRJ, Spalding DRC, Pai M, Sharma R, Pinato DJ, Spicer J, Hunter S, Kwatra V, Nicholls JP, Collin D, Nutbrown R, Glenny H, Fairbairn S, Reebye V, Voutila J, Dorman S, Andrikakou P, Lloyd P, Felstead S, Vasara J, Habib R, Wood C, Saetrom P, Huber HE, Blakey DC, Rossi JJ, Habib N. MTL-CEBPA, a Small Activating RNA Therapeutic Upregulating C/EBP-alpha, in Patients with Advanced Liver Cancer: A First-in-Human, Multicenter, Open-Label, Phase I Trial. Clin Cancer Res. 2020 Aug 1;26(15):3936-3946. doi: 10.1158/1078-0432.CCR-20-0414. Epub 2020 May 1.
Related Links
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Company Webpage
Other Identifiers
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2015-003051-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20332
Identifier Type: OTHER
Identifier Source: secondary_id
MNA-3521-011
Identifier Type: -
Identifier Source: org_study_id
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