A Multicenter, Open-label, Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of SOT201 in Patients With Advanced/Metastatic Solid Tumors
SOTIO Biotech AG
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
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 fi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Criteria: Inclusion criteria: Type of patients * Patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with available therapies for their disease that are known to confer clinical benefit * Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology; lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions * Accessible tumor tissue available for fresh biopsy or being considered for tumor biopsy according to t…
Interventions
- DrugSOT201
intravenous infusion
Locations (7)
- MD Anderson Cancer CenterHouston, Texas
- Universitair Ziekenhuis Antwerpen (UZA)Edegem, Antwerp
- Institut Jules BordetAnderlecht, Brussels Capital
- Masarykův Onkologický ÚstavBrno
- Fakultni Nemocnice Olomouc (FNOL) - Onkologicka KlinikaOlomouc
- Institut Gustave RoussyParis