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ClinicalTrials.gov ID

NCT05752552

Lead Sponsor

DeuterOncologyINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 1

Enrollment

55Estimated

Last Update Posted

Apr 3, 2026Actual

Start Date

Dec 20, 2022Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Sep 2028Estimated

Official Title

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

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.

Detailed 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.

In part 2, up to 30 evaluable patients with locally advanced, unresectable or metastatic non-small-cell cancer (NSCLC), no longer eligible for approved, available standard therapies and having tumour harbouring MET exon14 skipping mutation from an assessment not older than 3 months, will received DO-2 at the selected dose.

• Adult Solid Tumor
• Advanced Solid Tumor
• Refractory Tumor
• Non-small Cell Lung Cancer
• Non-small Cell Carcinoma
• Lung Cancer
• Hereditary Renal Papillary Cancer

• DO-2

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

DeuterOncologyINDUSTRY

Hans.Prenen@uza.be+3238213646

christophe.dooms@UZLeuven.be+3216340961