Non-Small Cell Lung Cancer Clinical Trial
Official title:
MesomiR 1: A Phase I Study of Intravenously Administered Epidermal Growth Factor Receptor -Targeted, EnGeneIC Delivery Vehicle (EDV)-Packaged, miR-16 Mimic (TargomiRs) for Patients With Malignant Pleural Mesothelioma (MPM) and Advanced Non-Small Cell Lung Cancer (NSCLC) Failing on Std Therapy
The first testing of TargomiRs in the human setting: dose-finding studies in patients with recurrent malignant pleural mesothelioma and non-small cell lung cancer
TargomiRs are targeted minicells containing a microRNA mimic. They consist of three
components: 1. A miR-16-based microRNA mimic. The miR-16 family has been implicated as a
tumour suppressor in a range of cancer types. The mimic is a double-stranded, 23 base pair,
synthetic RNA molecule. 2. Drug delivery vehicle - EDVs. EDVs are nonliving bacterial
minicells (nanoparticles). They function as leak resistant micro-reservoir carriers that
allow efficient packaging of a range of different drugs, proteins or nucleic acids. 3.
Targeting moiety. The EDVs are targeted to EGFR-expressing cancer cells with an anti-EGFR
bispecific antibody.
TargomiRs are IV injected.
Phase 1 Planned dose levels
Dose level 1: 5 billion once a week Dose level 2: 5 billion twice a week Dose level 3: 5
billion once a week with cardiac monitoring Dose level 4: 2.5 billion twice and week with
cardiac monitoring Dose level 5: as above with an additional dexamethasone challenge
All patients begin on a micro dose of 1 billion once a week and escalate to the full phase 1
dose for their dose level on week 3.
Duration of treatment for each dose level is on a patient by patient basis. Officially the
cycle is 8 weeks long however a patient can continue on treatment if they are deriving
clinical benefit from the treatment.
If at any time point before or after the 8 week mark, a patient progresses, experiences
ongoing or unreasonable toxicities or withdraws from the study, they will cease treatment.
Escalation of dose in cohorts of 3-6 patients per dose level. If at least 2 patients are
observed to experience Dose Limiting Toxicity (DLT), the prior dose level is defined as the
MTD.
Adherence to the protocol tends not to be problematic in patient groups where the trial
treatment is their only treatment option. They are often very keen to participate and
motivated to be part of the research.
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