NCT05052255

RVU120 (SEL120) in Patients with Relapse/Refractory Metastatic or Advanced Solid Tumors

An Open-label, Single Agent, Phase I/II Trial Investigating the Safety and Efficacy of RVU120 (SEL120) in Patients with Relapse / Refractory Metastatic or Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ryvu Therapeutics SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	RVU120	RVU120 will be administered as a single oral dose every other day over a 3 week treatment cycle until disease progression or unacceptable toxicity and an alternative daily dosing schedule will also be tested.

Timeline

• Start date: 2021-08-13
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2021-09-22
• Last updated: 2024-12-17

Locations

7 sites across 2 countries: Poland, Spain