BridgeMD
Tests treatment safety and results for Adult Solid Tumor
Official title Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours
ClinicalTrials.gov ID: NCT05752552
What this study is testing
What is DO-2?
DO-2 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for adult solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years or older
- histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, no longer eligible for approved, available standard...
- 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
You likely can't join 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...
- 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:
See the full eligibility 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Edegem, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Bordeaux, France
- Lille, France
- Lyon, France
- Marseille, France
- Nice, France
- Rennes, France
- Villejuif, France
- Nijmegen, Netherlands
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Edegem, Belgium; Ghent, Belgium; Leuven, Belgium; Bordeaux, France; Lille, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.