Trial Title:
Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients with Advanced or Refractory Solid Tumours
NCT ID:
NCT05752552
Condition:
Adult Solid Tumor
Advanced Solid Tumor
Refractory Tumor
Non-small Cell Lung Cancer
Non-small Cell Carcinoma
Lung Cancer
Hereditary Renal Papillary Cancer
Conditions: Official terms:
Neoplasms
Lung Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DO-2
Description:
Deuterated MET kinase inhibitor
Arm group label:
Cohort 1 (starting dose)
Arm group label:
Cohort 2 (dose level 2)
Arm group label:
Cohort 3 (dose level 3)
Arm group label:
Cohort 4 (dose level 4)
Arm group label:
Cohort 5 (dose level 5)
Arm group label:
Cohort 6 (dose level 6)
Arm group label:
Cohort 7 (dose level 7)
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.
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Roi Albert II - UC Louvain
Address:
City:
Bruxelles
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Jean-Pascal Machiels, Prof.
Phone:
+3227645457
Email:
jean-pascal.machiels@saintluc.uclouvain.be
Contact backup:
Email:
rachel.galot@saintluc.uclouvain.be
Contact backup:
Last name:
Rachel Galot, Dr
Facility:
Name:
UZA
Address:
City:
Edegem
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Hans Prenen, Prof
Phone:
+3238213646
Email:
Hans.Prenen@uza.be
Facility:
Name:
Universitair Ziekenhuis Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Sylvie Rottey, Prof. MD.
Facility:
Name:
Centre Georges-François Leclerc - CHU Dijon
Address:
City:
Dijon
Country:
France
Status:
Recruiting
Contact:
Last name:
François Ghiringhelli, Prof. MD
Facility:
Name:
Institut Cœur Poumon - CHU Lille
Address:
City:
Lille
Country:
France
Status:
Recruiting
Contact:
Last name:
Alexis Cortot, Prof. MD
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Country:
France
Status:
Recruiting
Contact:
Last name:
Aurélie Swalduz, MD
Facility:
Name:
Radboud UMC
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Carla Van Herpen, Prof. MD
Facility:
Name:
Erasmus Medical Centre
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Debbie Robbrecht, Dr
Email:
d.robbrecht@erasmusmc.nl
Contact backup:
Phone:
+31107041733
Start date:
December 20, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
DeuterOncology
Agency class:
Industry
Source:
DeuterOncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05752552
https://www.deuteroncology.com/
