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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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

Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours (NCT05752552) is a Phase 1 interventional studying Adult Solid Tumor and Advanced Solid Tumor, sponsored by DeuterOncology. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Adult Solid Tumor, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 55 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Adult Solid Tumor subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 18 years or older - diagnosed by tissue sample (biopsy-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 - 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 willing to sign a consent form, indicating study patients understand the purpose of and procedures required for the study and are willing to participate in the study. Who Should NOT Join This Trial: - 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: 1. CNS lesions are asymptomatic and previously treated 2. No ongoing requirement for corticosteroids as therapy for cancer that has spread to the brain 3. Imaging demonstrates stability of disease \> 28 days from last treatment for cancer that has spread to the brain - leptomeningeal involvement (leptomeningeal carcinomatosis) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion 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 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 * 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. Exclusion Criteria: * 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: 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 * inability or unwillingness to swallow capsules and malabsorption syndrome or other condition that would interfere with enteral absorption

Treatments Being Tested

DRUG

DO-2

Deuterated MET kinase inhibitor

Locations (13)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Institut Roi Albert II - UC Louvain
Brussels, Belgium
UZA
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Institut Bergonie
Bordeaux, France
Institut Cœur Poumon - CHU Lille
Lille, France
Centre Léon Bérard
Lyon, France
Hôpitaux Universitaires de Marseille Timone
Marseille, France
Centre Antoine Lacassagne
Nice, France
Centre Hospitalier Universitaire De Rennes
Rennes, France
Institut Gustave Roussy
Villejuif, France
Radboud UMC
Nijmegen, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05752552), the sponsor (DeuterOncology), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05752552 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05752552?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05752552?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05752552. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05752552. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.