This study is a first-in-human, open-label, 2-part, Phase 1 dose escalation study of DO-2, administered orally to patients with advanced or refractory solid tumours, with MET aberrations, and no available, approved therapeutic alternative. The dose escalation is completed, Part 2 of the study is ongoing.
In Part 1, a Simon Design 3 accelerated titration design will be followed. One patient will be enrolled per cohort, until grade 2 toxicity is observed. Three sequential patients per cohort will be enrolled thereafter, with a minimum of 1 week between first dose administration in the first patient and the subsequent ones, in those latter cohorts. In part 2, up to 30 evaluable patients with locally advanced, unresectable or metastatic non-small-cell cancer (NSCLC), no longer eligible for approved, available standard therapies and having tumour harbouring MET exon14 skipping mutation from an assessment not older than 3 months, will received DO-2 at the selected dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Deuterated MET kinase inhibitor
Institut Roi Albert II - UC Louvain
Brussels, Belgium
RECRUITINGUZA
Edegem, Belgium
RECRUITINGUniversitair Ziekenhuis Gent
Ghent, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGInstitut Bergonie
Bordeaux, France
RECRUITINGInstitut Cœur Poumon - CHU Lille
Lille, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGHôpitaux Universitaires de Marseille Timone
Marseille, France
NOT_YET_RECRUITINGCentre Antoine Lacassagne
Nice, France
NOT_YET_RECRUITINGCentre Hospitalier Universitaire De Rennes
Rennes, France
RECRUITING...and 3 more locations
Number of subjects who experience specific treatment-related adverse events (TRAEs)
Number of subjects with specific treatment-related adverse events for each dose group. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment. TRAEs are any event that occurs after the subject has received study treatment. AE grading will be performed in accordance with NCI-CTC Version 5.0.
Time frame: Baseline through study completion, an average of 12 months
Objective responses rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR. Radiologic assessment will be repeated after every second cycle (or more frequently if clinically indicated) and using same methodology as at baseline. Response assessment (radiologic) will be determined in accordance with RECIST (version 1.1) and current disease specific solid tumour response criteria.
Time frame: Baseline through study completion, an average of 12 months
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame: Baseline through study completion, an average of 12 months
Disease Control Rate (DCR)
Rate of patients who achieve either a Complete Response (CR) or a Partial Response (PR) or Stable Disease (SD) at Week 6 and Week 14
Time frame: Baseline through study completion, an average of 12 months
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).
Time frame: Baseline through study completion, an average of 12 months
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Time frame: Baseline through study completion, an average of 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.