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

Last updated: November 5, 2024
Sponsor: DeuterOncology
Overall Status: Active - Recruiting

Phase

1

Condition

Lung Cancer

Non-small Cell Lung Cancer

Cancer

Treatment

DO-2

Clinical Study ID

NCT05752552
DO2.22.01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older

  • histologically or cytologically confirmed advanced or refractory solid tumour and nolonger eligible for approved, available standard therapies. Tumour types must have:

  1. proven MET activating mutations, determined by previous next generationsequencing (NGS), whole exome sequencing (WES), whole transcriptome sequencing (WTS) or other genomic analysis methods, or

  2. proven amplification (≥ 10 copies) on archived tumour tissue. or

  3. Hereditary Renal Papillary Cancer

  • 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

  • agree to follow the contraception requirements of the trial

  • signed informed consent, indicating study patients understand the purpose of andprocedures required for the study and are willing to participate in the study.

Exclusion

Exclusion Criteria:

  • major surgery within 3 weeks before enrollment

  • chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks),radiotherapy, immunotherapy, or any other study drug within 3 weeks before studydrug administration

  • antibody based cancer therapy within 4 weeks before administration of the first doseof 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 aremet:

  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 CNSmetastases

  • leptomeningeal involvement (leptomeningeal carcinomatosis)

  • history of uncontrolled heart disease including unstable angina, congestive heartfailure, myocardial infarction within preceding 12 months, clinically significantrhythm or conduction abnormality, congenital long QT syndrome, obligate use of acardiac pacemaker, QTc at screening greater than 450 milliseconds in males andgreater than 470 milliseconds in females

  • uncontrolled arterial hypertension despite appropriate therapy

  • positive pregnancy test (urinary beta-hCG) at screening (applicable to women ofchild-bearing potential who are sexually active)

  • mental status alteration or history of major psychiatric illness, which maypotentially 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 opinionof the investigator makes it undesirable for a patient to participate

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: DO-2
Phase: 1
Study Start date:
December 20, 2022
Estimated Completion Date:
December 31, 2026

Study Description

In Part 1, a Simon Design 3 accelerated titration design will be followed. One patient will be enrolled per cohort, until grade 2 toxicity is observed. Three sequential patients per cohort will be enrolled thereafter, with a minimum of 1 week between first dose administration in the first patient and the subsequent ones, in those latter cohorts.

Connect with a study center

  • Institut Roi Albert II - UC Louvain

    Bruxelles,
    Belgium

    Active - Recruiting

  • UZA

    Edegem,
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Centre Georges-François Leclerc - CHU Dijon

    Dijon,
    France

    Active - Recruiting

  • Institut Cœur Poumon - CHU Lille

    Lille,
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon,
    France

    Active - Recruiting

  • Radboud UMC

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Erasmus Medical Centre

    Rotterdam,
    Netherlands

    Active - Recruiting

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