Clinical trial · Interventional
ODM-207 in Patients With Advance Solid Tumours
Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion
NCT03035591CI-TRIAL-00041147BETIDEScompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ODM-207 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ODM-207
- description
- Escalating doses of ODM-207
- interventionNames
- Drug: ODM-207
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- 28 days
- description
- Highest dose level at which \<33% of patients in a cohort experience Dose Limiting Toxicity (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy * Life expectancy \>12 weeks * Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression * ECOG performance status of 0 to 1 Exclusion Criteria: * History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment * Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment) * History of or current leptomeningeal or brain metastasis or spinal cord compression.
References
Publications (1)
- DERIVEDAmeratunga M, Brana I, Bono P, Postel-Vinay S, Plummer R, Aspegren J, Korjamo T, Snapir A, de Bono JS. First-in-human Phase 1 open label study of the BET inhibitor ODM-207 in patients with selected solid tumours. Br J Cancer. 2020 Dec;123(12):1730-1736. doi: 10.1038/s41416-020-01077-z. Epub 2020 Sep 29. PMID 32989226