NCT06163391

A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer

A Multicenter, Open-label, Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of SOT201 in Patients With Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: SOTIO Biotech AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W) will be determined

Detailed description

Duration of the study for a participant will include: Screening period: Up to 21 days before day 1 of cycle 1 (can be prolonged up to 42 days, if required due to fresh biopsy) Treatment Period: enrolled and exposed participants will receive continuous treatment until progressive disease (PD), or an occurrence of an unacceptable AE, a withdrawal of consent, or until other permanent discontinuation criteria described in the protocol are met. End of treatment will occur within 7 (+7) days after the SOT201 discontinuation, and Follow-up period. Every 30 (±2) days until 90 (+7) days after the final dose of SOT201, until disease progression, the start of new anticancer therapy, death, or withdrawal of participant's consent, whichever comes first.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	SOT201	intravenous infusion

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-12-08
• Last updated: 2025-06-29

Locations

7 sites across 5 countries: United States, Belgium, Czechia, France, Spain

Regulatory

• FDA-regulated drug study