Adult Solid TumorPhase 1NCT05752552
Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours
A Phase 1 study testing DO-2 in people with Adult Solid Tumor and Advanced Solid Tumor, run by DeuterOncology at 13 sites in 3 countries.
Trial 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. The dose escalation is completed, Part 2 of the study is ongoing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Solid Tumor, Advanced Solid Tumor, Refractory Tumor
- What is being tested?
- DO-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 20 Dec 2022to Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 mutation, determined by local next generation sequencing (NGS), whole exome sequencing (WES), whole transcriptome sequencing (WTS) or other genomic analysis methods, from an assessment not older than 3 months
- 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
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- 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.
Who cannot join
- 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:
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- 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 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
- inability or unwillingness to swallow capsules and malabsorption syndrome or other condition that would interfere with enteral absorption
Trial locations and contacts
13 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Desirée Kanters contact
13 sites in 3 countries
France7 sites, 7 recruiting
- Recruiting
Institut Bergonie
Bordeaux
Dr. Sophie Cousin, +33556333229, s.cousin@bordeaux.unicancer.fr
- Recruiting
Institut Cœur Poumon - CHU Lille
Lille
Alexis Cortot, Prof. MD, +3320444998, alexis.cortot@chu-lille.fr
- Recruiting
Centre Léon Bérard
Lyon
Aurélie Swalduz, MD, +33426556761, aurelie.swalduz@lyon.unicancer.fr
- Not yet recruiting
Hôpitaux Universitaires de Marseille Timone
Marseille, 13385
Prof. Dr. Laurent Greillier, +33491965901, laurent.greillier@ap-hm.fr
- Not yet recruiting
Centre Antoine Lacassagne
Nice
Dr. Victoria Ferrari, +33492031324, Victoria.ferrari@nice.unicancer.fr
- Recruiting
Centre Hospitalier Universitaire De Rennes
Rennes
Prof. Dr. Charles Ricordel, +33299283738, charles.ricordel@chu-rennes.fr
- Not yet recruiting
Institut Gustave Roussy
Villejuif
Prof. Dr. Jordi Remon-Masi, +33142113145, Jordi.REMON-MASIP@gustaveroussy.fr
Belgium4 sites, 4 recruiting
- Recruiting
Institut Roi Albert II - UC Louvain
Brussels
Jean-Pascal Machiels, Prof., +3227645457, jean-pascal.machiels@saintluc.uclouvain.be
rachel.galot@saintluc.uclouvain.be
- Recruiting
UZA
Edegem
Hans Prenen, Prof, +3238213646, Hans.Prenen@uza.be
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Sylvie Rottey, Prof. MD., +3293322111, sylvie.rottey@UGent.be
- Recruiting
UZ Leuven
Leuven
Prof. Dr. Christophe Dooms, +3216340961, christophe.dooms@UZLeuven.be
Netherlands2 sites, 2 recruiting
- Recruiting
Radboud UMC
Nijmegen
Prof. Dr. Carla Van Herpen, +31243610353, Carla.Vanherpen@radboudumc.nl
- Recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam
Dr. Marthe Paats, +31107034862, m.paats@erasmusmc.nl
+31107041733
About this study
Official title: A Phase 1 Study to Determine the Safety, and Pharmacokinetics of the Selective MET Kinase Inhibitor, DO-2 in Patients With Advanced or Refractory Solid Tumours
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.
Read the 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.
In part 2, up to 30 evaluable patients with locally advanced, unresectable or metastatic non-small-cell cancer (NSCLC), no longer eligible for approved, available standard therapies and having tumour harbouring MET exon14 skipping mutation from an assessment not older than 3 months, will received DO-2 at the selected dose.
- Conditions
- Adult Solid Tumor, Advanced Solid Tumor, Refractory Tumor, Non-small Cell Lung Cancer, Non-small Cell Carcinoma, Lung Cancer
- Being tested
- DO-2
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DO-2Drug
Deuterated MET kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Expansion Cohort | Experimental | Oral administration, once a day for 28 days, in a 4-week cycle of DO-2 at the selected dose Receives: Drug: DO-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects who experience specific treatment-related adverse events (TRAEs)
Number of subjects with specific treatment-related adverse events for each dose group.
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment. TRAEs are any event that occurs after the subject has received study treatment. AE grading will be performed in accordance with NCI-CTC Version 5.0.
Measured: Baseline through study completion, an average of 12 months
Secondary outcomes (5)
Objective responses rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR. Radiologic assessment will be repeated after every second cycle (or more frequently if clinically indicated) and using same methodology as at baseline. Response assessment (radiologic) will be determined in accordance with RECIST (version 1.1) and current disease specific solid tumour response criteria.
Measured: Baseline through study completion, an average of 12 months
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Measured: Baseline through study completion, an average of 12 months
Disease Control Rate (DCR)
Rate of patients who achieve either a Complete Response (CR) or a Partial Response (PR) or Stable Disease (SD) at Week 6 and Week 14
Measured: Baseline through study completion, an average of 12 months
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).
Measured: Baseline through study completion, an average of 12 months
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Measured: Baseline through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start20 Dec 2022
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation followed by a study single expansion arm
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DeuterOncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaap Verweij, MD, Study chair, CMO DeuterOncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752552
- Sponsor's protocol ID
- DO2.22.01
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Determine the Safety, and Pharmacokinetics of the Selective MET Kinase Inhibitor, DO-2 in Patients With Advanced or Refractory Solid Tumours
- ClinicalTrials.gov ID
- NCT05752552
- Acronym / sponsor ID
- DO2.22.01
- Conditions
- Adult Solid Tumor, Advanced Solid Tumor, Refractory Tumor, Non-small Cell Lung Cancer, Non-small Cell Carcinoma, Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- DeuterOncologyIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
In part 2, up to 30 evaluable patients with locally advanced, unresectable or metastatic non-small-cell cancer (NSCLC), no longer eligible for approved, available standard therapies and having tumour harbouring MET exon14 skipping mutation from an assessment not older than 3 months, will received DO-2 at the selected dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation followed by a study single expansion arm
| Arm | Type | Receives |
|---|---|---|
| Expansion Cohort | Experimental | Drug: DO-2Oral administration, once a day for 28 days, in a 4-week cycle of DO-2 at the selected dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 mutation, determined by local next generation sequencing (NGS), whole exome sequencing (WES), whole transcriptome sequencing (WTS) or other genomic analysis methods, from an assessment not older than 3 months
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DO-2Deuterated MET kinase inhibitor | Drug | Expansion Cohort |
Primary outcome
Number of subjects who experience specific treatment-related adverse events (TRAEs)
Time frame: Baseline through study completion, an average of 12 months
Number of subjects with specific treatment-related adverse events for each dose group. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment. TRAEs are any event that occurs after the subject has received study treatment. AE grading will be performed in accordance with NCI-CTC Version 5.0.
5 secondary outcomes
Objective responses rate (ORR)
Time frame: Baseline through study completion, an average of 12 months
Duration of response (DoR)
Time frame: Baseline through study completion, an average of 12 months
Disease Control Rate (DCR)
Time frame: Baseline through study completion, an average of 12 months
Progression-free survival (PFS)
Time frame: Baseline through study completion, an average of 12 months
Overall survival (OS)
Time frame: Baseline through study completion, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- DeuterOncology Internet siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Desirée Kanters contact
Jaap Verweij, MD study chair
CMO DeuterOncology
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DO-2 in people with Adult Solid Tumor and Advanced Solid Tumor, run by DeuterOncology at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Perera, PhD (+32473558353, tperera@deuteroncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who experience specific treatment-related adverse events (TRAEs) (time frame: Baseline through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.