NL-OMON51802
Not yet recruiting
Not Applicable
A Phase 1 Study to Determine the Safety, and Pharmacokinetics of the Selective MET kinase Inhibitor, DO-2 in Patients With Advanced or Refractory Solid Tumours - Phase 1 study of DO-2 in solid tumours
DeuterOncology NV0 sites15 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- DeuterOncology NV
- Enrollment
- 15
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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,
- •b. proven amplification (\>\= 10 copies) on archived tumour tissue.
- •c. Hereditary Renal Papillary Cancer
- •3\. Eastern Cooperative Oncology Group (ECOG) performance status of \<\= 2
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
Outcomes
Primary Outcomes
Not specified
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