A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cance
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) wil
| Condition(s) | Advanced Solid Tumor, Metastatic Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 |
| Who can participate | 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 the treating institution's guidelines and willing to undergo a new biopsy if not clinically contraindicated Note: Newly obtained tumor tissue (to be taken at baseline) is preferred to an archival sample. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | SOTIO Biotech AG |
| Locations | Houston, Texas, United States; Edegem, Antwerp, Belgium; Anderlecht, Brussels Capital, Belgium; Brno, Czechia; Olomouc, Czechia; Paris, France (+1 more sites) |
| Start date | 2024-05-01 |
| NCT ID | NCT06163391 |
| Official listing | https://clinicaltrials.gov/study/NCT06163391 |