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Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours

RecruitingPhase 1Ages 18 Years - anyAllDeuterOncology
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years or older * histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, no longer eligible for approved, available standard therapies. To be entered patients must have proven MET exon 14 skipping mutation, determined by local next generation sequencing (NGS), whole exome sequencing (WES), whole transcriptome sequencing (WTS) or other genomic analysis methods, from an assessment not older than 3 months * measurable disease in accordance with RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * adequate bone marrow function, without the support of cytokines * adequate liver function * adequate renal function with serum creatinine \<1 x institutional UNL and GFR within normal range * agree to follow the contraception requirements of the trial * signed informed consent, indicating study patients understand the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria: * tumour harbouring other known oncogenic mutations promoting tumour growth * major surgery within 3 weeks before enrolment * chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy, or any other study drug within 3 weeks before study drug administration * antibody based cancer therapy within 4 weeks before administration of the first dose of DO-2 * patients who became progressive on previous treatment with a MET-kinase inhibitor * patients with brain metastases are excluded unless all of the following criteria are met: 1. CNS lesions are asymptomatic and previously treated 2. No ongoing requirement for corticosteroids as therapy for CNS metastases 3. Imaging demonstrates stability of disease \> 28 days from last treatment for CNS metastases * leptomeningeal involvement (leptomeningeal carcinomatosis) * history of uncontrolled heart disease including unstable angina, congestive heart failure, myocardial infarction within preceding 12 months, clinically significant rhythm or conduction abnormality, congenital long QT syndrome, obligate use of a cardiac pacemaker, QTc at screening greater than 450 milliseconds in males and greater than 470 milliseconds in females * uncontrolled arterial hypertension despite appropriate therapy * positive pregnancy test (urinary beta-hCG) at screening (applicable to women of child-bearing potential who are sexually active) * mental status alteration or history of major psychiatric illness, which may potentially impair patient's compliance with study procedures * signs and symptoms of active infection requiring systemic therapy * other medical condition (e.g. pre-existing kidney dysfunction) that in the opinion of the investigator makes it undesirable for a patient to participate * inability or unwillingness to swallow capsules and malabsorption syndrome or other condition that would interfere with enteral absorption
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What it tests

  • DO-2
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Where

13 sites
Institut Roi Albert II - UC Louvain
Brussels, Belgium
UZA
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Institut Bergonie
Bordeaux, France
Institut Cœur Poumon - CHU Lille
Lille, France
Centre Léon Bérard
Lyon, France
Hôpitaux Universitaires de Marseille Timone
Marseille, France

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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