NCT05752552 Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours
| NCT ID | NCT05752552 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | DeuterOncology |
| Condition | Adult Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2022-12-20 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 55 participants in total. It began in 2022-12-20 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Jaap Verweij, MD
STUDY CHAIR
CMO DeuterOncology
Frequently Asked Questions
Who can join the NCT05752552 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adult Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05752552 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05752552 currently recruiting?
Yes, NCT05752552 is actively recruiting participants. Contact the research team at tperera@deuteroncology.com for enrollment information.
Where is the NCT05752552 trial being conducted?
This trial is being conducted at Brussels, Belgium, Edegem, Belgium, Ghent, Belgium, Leuven, Belgium and 9 additional locations.
Who is sponsoring the NCT05752552 clinical trial?
NCT05752552 is sponsored by DeuterOncology. The principal investigator is Jaap Verweij, MD at CMO DeuterOncology. The trial plans to enroll 55 participants.