Last updated on June 2018

OMO-1 in Solid Malignancies

Brief description of study

This is a modular, first time in patient, open-label, multicentre study of OMO-1, administered orally, alone and in combination with anti-cancer treatments, in patients with locally advanced, unresectable or metastatic solid malignancies.

Detailed Study Description

The study will consist of a number of study modules - the first of which is Module 1.

Combination study modules will consist of a Part A (dose finding) and an optional Part B (cohort expansion). The option to start Part B and add further modules will be the decision of the safety review committee, based on emerging preclinical anti-tumour data and, safety and tolerability information from the study as a whole. A substantial protocol amendment with relevant preclinical and emerging clinical data will be put in place before starting a new combination module.

The initial dosing schedule and/or sequence of OMO-1 in each module may be subsequently changed between patient cohorts in response to emerging safety, pharmacokinetic (PK) and pharmacodynamic (PDc) findings. The maximum tolerated dose (MTD) of OMO-1 for individual modules may therefore differ based on the emerging safety profile for each combination.

Once a minimally biologically active dose (MBAD) of OMO-1 for a module has been identified from Part A of that module, the safety review committee may decide to commence Part B. This may include cohort expansions of specific patient groups to explore preliminary anti-tumour activity or the effect of food or particular drug combinations on drug PK.

For all modules, Part A cohorts (dose escalation) may be expanded by up to 12 additional patients at doses (at or above the MBAD) that have been confirmed to be tolerated. These patients will have mandatory serial biopsies to assess the tumour for relevant PDc biomarkers, and to explore further the tolerability, safety and PK activity at these doses.

In all combination modules, the dose of each combination agent investigated will not exceed their current recommended dose. The starting dose of OMO-1 in combination modules will not exceed the one currently tolerated in Module 1 (monotherapy). For cohorts in which OMO-1 is dosed in combination with cytotoxic chemotherapy, dosing will not continue once the cycles of chemotherapy have been completed.

Clinical Study Identifier: NCT03138083

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The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle upon Tyne, United Kingdom
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Recruitment Status: Open

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