RVU120 (SEL120) in Patients with Relapse/Refractory Metastatic or Advanced Solid Tumors
- Registration Number
- NCT05052255
- Lead Sponsor
- Ryvu Therapeutics SA
- Brief Summary
This is a phase 1/2, dose-escalation and expansion study investigating the safety, pharmacokinetics, and efficacy of RVU120 (SEL120) in patients with metastatic or advanced solid tumors progressing from previous lines of therapy.
- Detailed Description
The dose-escalation phase (Part 1) will be followed by an expansion phase (Part 2). Part 1 will evaluate the safety/tolerability and pharmacokinetics of increasing doses of RVU120 (SEL120) administered as a single dose every other day (7 doses in a 3 week cycle). Part 2 will collect additional data on safety, pharmacokinetics and efficacy at the recommended dose in patients with tumor types selected in Part 1.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1: Dose Escalation / Part 2: Cohort Expansion RVU120 Part 1-Dose Escalation: Escalating doses of RVU120, in patients who have progressed from previous therapy. Part 2-Cohort Expansion and Alternative Schedule Investigation: Recommended dose in patients with tumor types selected from part 1 and escalation for alternative schedule.
- Primary Outcome Measures
Name Time Method Progression Free Survival in part II Up to 2 years Progression Free Survival as Assessed by RECIST v1.1
Dose Finding in part I Up to 2 years Determination of Recommended phase 2 dose assessing all available data
Objective Overall Response in part II Up to 2 years Objective Overall Response as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)
Duration of Response in part II Up to 2 years Duration of Response, as Assessed by RECIST v1.1
Adverse events in part I Up to 2 years Evaluation of frequency and nature of adverse events, serious adverse events and dose limiting toxicities
Overall Survival in part II Up to 2 years Assessment of Overall Survival from the date of first dose until the date of death from any cause
- Secondary Outcome Measures
Name Time Method Progression Free Survival Up to 2 years Progression Free Survival as Assessed by RECIST v1.1
Maximum Plasma Concentration (Cmax) Up to 2 years Assessed of the maximum plasma concentration (Cmax)
Time to Cmax Up to 2 years Assessed of the Time to Cmax (Tmax)
Objective Overall Response Up to 2 years Objective Overall Response as Assessed by RECIST v1.1
Duration of Response Up to 2 years Duration of Response, as Assessed by RECIST v1.1
Minimum Plasma Concentration (Cmin) Up to 2 years Assessed of the minimum plasma concentration (Cmin)
Overall Survival Up to 2 years Assessment of Overall Survival from the date of first dose until the date of death from any cause
Area Under the Curve Up to 2 years Assessed of the Area Under the Concentration Time-Curve (AUC) from Time Zero to Dosing Interval (AUC0-tau)
Trial Locations
- Locations (7)
Beskidzkie Centrum Onkologii, Szpital Miejski im.
🇵🇱Bielsko-Biała, Poland
Medical University Early Phase 1 Research Center / Uniwersyteckie Centrum Kliniczne Ośrodek Badań Klinicznych Wczesnych Faz
🇵🇱Gdańsk, Poland
UCK im. prof. K. Gibińskiego
🇵🇱Katowice, Poland
Maria Sklodowska-Curie National Research Institute of Oncology / Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
🇵🇱Warsaw, Poland
Next Oncology Hospital Quironsalud Barcelona
🇪🇸Barcelona, Spain
Next Oncology Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcón, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain