Actively Recruiting
Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours
Led by DeuterOncology · Updated on 2026-04-03
55
Participants Needed
13
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Confirmed locally advanced, unresectable or metastatic NSCLC with MET exon 14 skipping mutation from testing no older than 3 months
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Adequate bone marrow function without cytokine support
- Adequate liver function
- Adequate kidney function with serum creatinine below institutional upper normal limit and normal GFR
- Agree to follow contraception requirements
- Signed informed consent indicating understanding and willingness to participate
You will not qualify if you...
- Tumor with other known oncogenic mutations that promote tumor growth
- Major surgery within 3 weeks before enrollment
- Chemotherapy (nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy, or other study drug within 3 weeks before DO-2 administration
- Antibody-based cancer therapy within 4 weeks before first DO-2 dose
- Previous progression on MET-kinase inhibitor treatment
- Brain metastases unless asymptomatic, previously treated, stable for over 28 days, and no ongoing corticosteroid use
- Leptomeningeal carcinomatosis
- Uncontrolled heart disease including unstable angina, recent heart attack, rhythm abnormalities, congenital long QT syndrome, pacemaker use, or prolonged QTc
- Uncontrolled arterial hypertension despite therapy
- Positive pregnancy test at screening for women of childbearing potential
- Mental status alteration or major psychiatric illness affecting compliance
- Active infection requiring systemic therapy
- Other medical conditions that make participation undesirable
- Inability or unwillingness to swallow capsules or conditions affecting absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Institut Roi Albert II - UC Louvain
Brussels, Belgium
Actively Recruiting
2
UZA
Edegem, Belgium
Actively Recruiting
3
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
4
UZ Leuven
Leuven, Belgium
Actively Recruiting
5
Institut Bergonie
Bordeaux, France
Actively Recruiting
6
Institut Cœur Poumon - CHU Lille
Lille, France
Actively Recruiting
7
Centre Léon Bérard
Lyon, France
Actively Recruiting
8
Hôpitaux Universitaires de Marseille Timone
Marseille, France, 13385
Not Yet Recruiting
9
Centre Antoine Lacassagne
Nice, France
Not Yet Recruiting
10
Centre Hospitalier Universitaire De Rennes
Rennes, France
Actively Recruiting
11
Institut Gustave Roussy
Villejuif, France
Not Yet Recruiting
12
Radboud UMC
Nijmegen, Netherlands
Actively Recruiting
13
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, Netherlands
Actively Recruiting
Research Team
T
Timothy Perera, PhD
CONTACT
D
Desirée Kanters
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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