All Advanced or Refractory Solid Tumours Advanced or Refractory Solid Tumours
Conditions
Interventions
None listed
Sponsors
DeuterOncology NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 18 years or older 2. histologically or cytologically confirmed advanced or refractory solid tumour and no longer eligible for approved, available standard therapies. Tumour types must have: a. proven MET activating mutations, determined by previous next generation sequencing (NGS), whole exome sequencing (WES), whole transcriptome sequencing (WTS) or other genomic analysis methods, or b. proven amplification (>= 10 copies) on archived tumour tissue. or c. Hereditary Renal Papillary Cancer 3. Eastern Cooperative Oncology Group (ECOG) performance status of 3,000/mm3, absolute neutrophil count (ANC) >1,500/mm3, platelet count >100,000/mm3, hemoglobin >10 g/dL 5. adequate liver function: total bilirubin level
Exclusion criteria
Exclusion criteria: 1. major surgery within 3 weeks before enrollment 2. 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 3. antibody based cancer therapy within 4 weeks before administration of the first dose of DO-2 4. patients with brain metastases are excluded unless all of the following criteria are met: a. CNS lesions are asymptomatic and previously treated b. No ongoing requirement for corticosteroids as therapy for CNS metastases c. Imaging demonstrates stability of disease >= 28 days from last treatment for CNS metastases 5. leptomeningeal involvement (leptomeningeal carcinomatosis) 6. 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. 7. uncontrolled arterial hypertension: systolic blood pressure of 160 mmHg or greater or diastolic blood pressure of 100 mmHg or greater or both, despite appropriate therapy. 8. positive pregnancy test (urinary beta hCG) at screening (applicable to women of child-bearing potential who are sexually active) 9. mental status alteration or history of major psychiatric illness, which may potentially impair patient*s compliance with study procedures 10. signs and symptoms of active infection requiring systemic therapy 11. other medical condition (e.g. pre-existing kidney dysfunction) that in the opinion of the investigator makes it undesirable for a patient to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Determine the recommended dose for further clinical studies. • Assess the preliminary antitumor activity in 3 defined cohorts. | — |
Countries
Netherlands
Outcome results
None listed