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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DeuterOncology

Criteria

Inclusion Criteria:

• 18 years or older

• histologically or cytologically confirmed advanced or refractory solid tumour and no longer eligible for approved, available standard therapies. Tumour types must have:

1. proven MET activating mutations, determined by previous next generation sequencing (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

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• 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 and procedures required for the study and are willing to participate in the study.

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 study drug administration

• antibody based cancer therapy within 4 weeks before administration of the first dose of DO-2

• 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