Phase
Condition
Lung Cancer
Non-small Cell Lung Cancer
Cancer
Treatment
DO-2
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years or older
histologically or cytologically confirmed advanced or refractory solid tumour and nolonger eligible for approved, available standard therapies. Tumour types must have:
proven MET activating mutations, determined by previous next generationsequencing (NGS), whole exome sequencing (WES), whole transcriptome sequencing (WTS) or other genomic analysis methods, or
proven amplification (≥ 10 copies) on archived tumour tissue. or
Hereditary Renal Papillary Cancer
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
agree to follow the contraception requirements of the trial
signed informed consent, indicating study patients understand the purpose of andprocedures required for the study and are willing to participate in the study.
Exclusion
Exclusion Criteria:
major surgery within 3 weeks before enrollment
chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks),radiotherapy, immunotherapy, or any other study drug within 3 weeks before studydrug administration
antibody based cancer therapy within 4 weeks before administration of the first doseof 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 aremet:
CNS lesions are asymptomatic and previously treated
No ongoing requirement for corticosteroids as therapy for CNS metastases
Imaging demonstrates stability of disease > 28 days from last treatment for CNSmetastases
leptomeningeal involvement (leptomeningeal carcinomatosis)
history of uncontrolled heart disease including unstable angina, congestive heartfailure, myocardial infarction within preceding 12 months, clinically significantrhythm or conduction abnormality, congenital long QT syndrome, obligate use of acardiac pacemaker, QTc at screening greater than 450 milliseconds in males andgreater than 470 milliseconds in females
uncontrolled arterial hypertension despite appropriate therapy
positive pregnancy test (urinary beta-hCG) at screening (applicable to women ofchild-bearing potential who are sexually active)
mental status alteration or history of major psychiatric illness, which maypotentially 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 opinionof the investigator makes it undesirable for a patient to participate
Study Design
Study Description
Connect with a study center
Institut Roi Albert II - UC Louvain
Bruxelles,
BelgiumActive - Recruiting
UZA
Edegem,
BelgiumActive - Recruiting
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumActive - Recruiting
Centre Georges-François Leclerc - CHU Dijon
Dijon,
FranceActive - Recruiting
Institut Cœur Poumon - CHU Lille
Lille,
FranceActive - Recruiting
Centre Léon Bérard
Lyon,
FranceActive - Recruiting
Radboud UMC
Nijmegen,
NetherlandsActive - Recruiting
Erasmus Medical Centre
Rotterdam,
NetherlandsActive - Recruiting
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