Tests DO-2 safety in adults with advanced or hard-to-treat solid tumours
Tests the oral drug DO-2 in adults with advanced solid tumours having MET changes.
Plain-language title generated from the registry record
Registry title: Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours
Key facts
- Where
- Nijmegen and Rotterdam, NetherlandsSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced lung cancer (NSCLC) that has a MET exon 14 skipping mutation and no approved treatment left to try. They would take DO-2 by mouth.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer that is locally advanced and cannot be removed by surgery, or has spread. Measurable disease (RECIST 1.1). ECOG performance status 1 or lower.
- Earlier treatment
- No longer able to use approved, available standard treatments. Cannot have had chemotherapy, radiotherapy, immunotherapy or another study drug within 3 weeks, or antibody cancer therapy within 4 weeks, before the first dose.
- Biomarker or test result
- Proven MET exon 14 skipping mutation, found by genetic testing no older than 3 months.
Main reasons for not taking part
- Tumour with other known cancer-driving mutations
- Cancer got worse on earlier treatment with a MET-kinase inhibitor
- Brain metastases, unless symptom-free, treated and stable for more than 28 days
- Leptomeningeal involvement
- Uncontrolled heart disease or uncontrolled high blood pressure
Read by machine on 12 November 2026.
Where in Netherlands
- Radboud UMCNijmegen, NetherlandsContact: Prof. Dr. Carla Van HerpenTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsContact: Dr. Marthe PaatsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- DeuterOncology
- Trial code
- NCT05752552
- Record updated
- 3 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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:; 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 CNS metastases; uncontrolled arterial hypertension despite appropriate therapy; 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; 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; tumour harbouring other known oncogenic mutations promoting tumour growth; leptomeningeal involvement (leptomeningeal carcinomatosis); positive pregnancy test (urinary beta-hCG) at screening (applicable to women of child-bearing potential who are sexually active).