A Study of OMX-0407 in Patients With Previously Treated Solid Tumours That Can't be Removed Surgically
- Registration Number
- NCT05826600
- Lead Sponsor
- iOmx Therapeutics AG
- Brief Summary
The main purpose of the dose escalation phase of the study is to determine the safety of different doses of OMX-0407.
The dose expansion (phase Ib) part of the study will evaluate efficacy, safety and tolerability at a dose determined in the dose escalation,
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 158
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description OMX-0407 - Escalation Phase OMX-0407 A starting daily dose of 20 mg OMX-0407 per participant split into twice daily 10 mg. Dose escalation will be determined by the safety monitoring committee. Dose for expansion will be determined by the safety monitoring committee. OMX-0407 - Expansion Phase (Phase Ib) OMX-0407 A dose of 100 mg OMX-0407 will be orally administered twice daily.
- Primary Outcome Measures
Name Time Method Identify Dose Limiting Toxicities 4 weeks (1 cycle) Incidence of dose limiting toxicities at each dose level
Identify objective response rate Every 12 weeks (3 cycles) Number of objective responses of OMX-0407 in patients with Renal Cell cancer, Non small cell lung cancer, urothelial cancer and angiosarcoma
- Secondary Outcome Measures
Name Time Method Maximum Tolerated Dose evaluated up to approximately 3 years Identify the maximum tolerated dose and recommended dose for Phase II based on toxicities at each dose level
Investigate the safety and tolerability of OMX-0407 through study completion, estimated up to approximately 3 years Incidence and severity of adverse events at each dose level
Pharmacokinetics (Cmax) of OMX-0407 evaluated up to approximately 3 years Maximum observed plasma concentration
Pharmacokinetics (Tmax) of OMX-0407 evaluated up to approximately 3 years Time of maximum observed plasma concentration
Pharmacokinetics (AUClast) of OMX-0407 evaluated up to approximately 3 years Area under the plasma concentration-time curve from time of dosing to the last quantifiable timepoint
Pharmacokinetics (AUCinf) of OMX-0407 evaluated up to approximately 3 years Area under the plasma concentration-time curve from time of dosing to infinity
Pharmacokinetics (% extrapolated-AUCinf) of OMX-0407 evaluated up to approximately 3 years The percentage of AUCinf derived via extrapolation from Tlast
Pharmacokinetics (t½) of OMX-0407 evaluated up to approximately 3 years Terminal elimination half-life
Measure Duration of Response every 12 weeks (3 cycles) Determine the median duration of response according to RECIST 1.1
Measure Progression Free Survivial every 12 weeks (3 cycles) Determine the median time for progression free survival
Measure Overall Response Rates every 12 weeks (3 cycles) Determine the overall number of responses
Measure Overall Survival every 12 weeks (3 cycles) Determine the survival times of patients
Assess Quality of Life Every 4 weeks (1 cycle) Determine changes in quality of life
Trial Locations
- Locations (15)
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
CHU de Liège
🇧🇪Liège, Belgium
ZAS Augustinus Afdeling Oncologische Research
🇧🇪Wilrijk, Belgium
ICO Hospitalet
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebrón
🇪🇸Barcelona, Spain
NEXT Oncology - Hospital Quironsalud Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Gregorio Marañon
🇪🇸Madrid, Spain
MD Anderson Cancer Center
🇪🇸Madrid, Spain
START Madrid - Hospital Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Centro Integral Oncológico Clara Campal
🇪🇸Madrid, Spain
NEXT Oncology - Hospital Universitario Quironsalud
🇪🇸Madrid, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital La Fe de Valencia
🇪🇸Valencia, Spain