Oral Administration of STC-15 in Subjects with Advanced Malignancies
- Registration Number
- NCT05584111
- Lead Sponsor
- STORM Therapeutics LTD
- Brief Summary
This Phase 1, multi-center, open-label, first-in-human study evaluates multiple ascending daily oral doses of STC-15 in Q3W treatment cycles in a 3+3 cohort design with dose levels determined by a modified Fibonacci algorithm. The study is designed to systematically assess safety and tolerability, pharmacokinetics, pharmacodynamics and clinical activity of STC-15 in adult subjects with advanced malignancies. Dose levels for further evaluation in expansion cohorts will be selected based on all available PK, pharmacodynamic, target engagement, efficacy, safety, and tolerability data including long-term safety data beyond dose limiting toxicities (DLTs). The study may be amended to evaluate STC-15 in combination with a Food and Drug Administration-approved standard of care treatment regimen, which could encompass targeted/chemotherapy, radiation therapy and/or immunotherapy with immune checkpoint blockers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- > 18 years of age
- Histologic or cytologic confirmation of advanced malignancy that has failed standard of care (SOC) therapy and no further SOC therapy is available or the subject has declined additional SOC therapy
- Adequate organ and marrow function
- ECOG PS of 0 or 1
Key
- Treatment with any local or systemic antineoplastic therapy within 3 weeks prior to first dose of STC-15
- Major surgery or radiation within the 3 weeks
- Immune-related AEs from immunotherapy that required permanent discontinuation
- Central nervous system (CNS) disease involvement, or prior history of Grade ≥3 drug-related CNS toxicity.
- Active autoimmune disease that has required systemic treatment in the 2 years prior to Screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Level 1 STC-15 30mg capsules, daily administration for 3 week (21 day) cycles Dose Level 2 STC-15 30mg capsules, MWF administration for 3 week (21 day) cycles Dose Level 4 STC-15 30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles Dose Level 5 STC-15 30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles Dose Level 3 STC-15 100mg capsules, MWF administration for 3 week (21 day) cycles
- Primary Outcome Measures
Name Time Method Number of participants with adverse events Screening through end of treatment, approximately 6 months To evaluate the incidence, severity, and duration of adverse events
Cmax (PK) Screening through Cycle 2 (each cycle is 21 days) To determine the Cmax concentration over a dosing interval, systemic clearance, volume of distribution at steady-state (Vss), and accumulation ratio from first dose to steady-state.
Tmax (PK) Screening through Cycle 2 (each cycle is 21 days) To determine the time to Cmax (Tmax)
Ctrough (PK) Screening through end of treatment, approximately 6 months To determine observed trough serum concentration (Ctrough)
Terminal elimination half life (PK) Screening through Cycle 2 (each cycle is 21 days) To determine the terminal elimination half-life (t½)
AUC (PK) Screening through Cycle 2 (each cycle is 21 days) To determine AUC in 1 dosing interval
Average concentration (PK) Screening through Cycle 2 (each cycle is 21 days) To determine the average concentration over a dosing interval
Systemic Clearance (PK) Screening through Cycle 2 (each cycle is 21 days) To determine the systemic clearance
Volume of distribution at steady-state (PK) Screening through Cycle 2 (each cycle is 21 days) To determine the volume of distribution at steady-state (Vss)
Accumulation ratio from first dose to steady-state (PK) Screening through end of treatment, approximately 6 months To determine the accumulation ratio from first dose to steady-state
- Secondary Outcome Measures
Name Time Method Efficacy as measured by RECIST 1.1 (DoR) Screening through disease progression, approximately 6 months Determine the duration of response (DoR)
Efficacy as measured by RECIST 1.1 (PFS) Screening through disease progression, approximately 6 months Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS).
Efficacy as measured by RECIST 1.1 (DCR) Screening through disease progression, approximately 6 months Determine the disease control rate (DCR)
Efficacy as measured by RECIST 1.1 (ORR) Screening through disease progression, approximately 6 months Determine the objective response rate (ORR)
Recommended Phase 2 Dose (RP2D) Screening through 90 days after the last dose of STC-15, approximately 9 months determine the RP2D for STC-15
Trial Locations
- Locations (3)
Honor Health
🇺🇸Scottsdale, Arizona, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States