A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer
- Registration Number
- NCT06163391
- Lead Sponsor
- SOTIO Biotech AG
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SOT201 SOT201 SOT201 will be administered intravenously once every 21 days
- Primary Outcome Measures
Name Time Method Number and percentages of participants with treatment-emergent adverse events (TEAEs) from patient signing the ICF up to 90 (+7) days after the last dose of SOT201, assessed approximately up to 3 years A TEAE is defined as an AE that started or worsened at or after the start of trial treatment Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Number of participants with dose-limiting toxicities (DLTs) 21 days of Cycle 1 plus 7 days of cycle 2 per cycle DLTs will be defined using NCI CTCAE version 5.0
- Secondary Outcome Measures
Name Time Method Characterization of maximum concentration (Cmax) of SOT201 Time Frame: From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17.) until cycle 20] Maximum plasma concentration observed
Characterization of pre-dose concentration (Ctrough) of SOT201 From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17..) until cycle 20 Pre-dose trough SOT201 concentrations
Objective response rate (ORR) From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years Proportion of patients who have a confirmed complete response (CR) or a partial response (PR), as the best overall response (BOR) determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Incidence of anti-drug antibodies (ADAs) against SOT201 Day 1 until 30 (±2) days after the last dose of SOT201 Incidence of patients with anti-drug antibodies
Characterization of area under the curve (AUClast, AUCinf, AUCtau) of SOT201 From Day 1 Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17.) until cycle 20 Area under the concentration versus time curve calculated using the trapezoidal method during a dosing interval (tau)
Characterization of time to maximum concentration (Tmax) of SOT201 From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17..) until cycle 20 Time to maximum concentration of SOT201
Duration of response (iDoR) From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years DoR is defined as the time from first documented evidence of confirmed CR or PR until progressive disease (PD) determined by Investigator per RECIST 1.1 or death from any cause, whichever occurs first
Clinical benefit rate (iCBR) From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST 1.1
Progression-free survival (iPFS) From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years PFS is defined as the time from the date of first administration of IMP to the date of the first documented disease progression determined by Investigator as per RECIST 1.1 or death from any cause, whichever occurs first
Trial Locations
- Locations (7)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Universitair Ziekenhuis Antwerpen (UZA)
🇧🇪Edegem, Antwerp, Belgium
Institut Jules Bordet
🇧🇪Anderlecht, Brussels, Belgium
Masarykův Onkologický Ústav
🇨🇿Brno, Czechia
Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika
🇨🇿Olomouc, Czechia
Institut Gustave Roussy
🇫🇷Paris, France
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
🇪🇸Barcelona, Spain