Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours

Recruiting now · Phase 1

Conditions studied: Adult Solid Tumor, Advanced Solid Tumor, Refractory Tumor, Non-small Cell Lung Cancer, Non-small Cell Carcinoma, Lung Cancer, Hereditary Renal Papillary Cancer

In brief

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.

Key facts

Study ID

NCT05752552

Run by

DeuterOncology

People needed

55

Starts

2022-12-20

Expected to finish

2028-09-01

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• 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
• 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

Where it is running

• Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) — Rotterdam, Netherlands (enrolling)
• UZA — Edegem, Belgium (enrolling)
• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Institut Bergonie — Bordeaux, France (enrolling)
• Institut Cœur Poumon - CHU Lille — Lille, France (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)
• Centre Hospitalier Universitaire De Rennes — Rennes, France (enrolling)
• Radboud UMC — Nijmegen, Netherlands (enrolling)
• Institut Roi Albert II - UC Louvain — Brussels, Belgium (enrolling)
• Hôpitaux Universitaires de Marseille Timone — Marseille, France
• Centre Antoine Lacassagne — Nice, France
• Institut Gustave Roussy — Villejuif, France

Full record on ClinicalTrials.gov

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