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

Launched by DEUTERONCOLOGY · Mar 1, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called DO-2, which is being tested for safety and how it works in patients with advanced or hard-to-treat solid tumors, such as certain types of lung cancer and hereditary renal papillary cancer. The study is open to adult patients who are at least 18 years old and have tumors that have specific genetic changes related to a gene called MET. To qualify, patients need to have tumors that have not responded to standard treatments and must have measurable disease, meaning their tumors can be tracked using imaging tests.

Participants in this trial will receive DO-2 in a controlled environment, and the study aims to find out the right dosage while monitoring for any side effects. If you or someone you know is considering joining the trial, it’s important to understand that there are specific criteria for participation, including good general health and no recent major surgeries or other cancer treatments. Patients will also need to provide informed consent, meaning they understand the study's purpose and procedures before they can join. This trial is a step towards finding new treatment options for patients who currently have limited choices.

Gender

ALL

Eligibility 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
• • 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 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 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