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Trial Title:
Oral Administration of STC-15 in Subjects With Advanced Malignancies
NCT ID:
NCT05584111
Condition:
Advanced Cancer
Advanced Solid Tumor
Cancer
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Oncology
METTL-3 Inhibitor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
STC-15
Description:
STC-15 oral capsules various dosing regimen in 3-week cycles
Arm group label:
Dose Level 1
Arm group label:
Dose Level 2
Arm group label:
Dose Level 3
Arm group label:
Dose Level 4
Arm group label:
Dose Level 5
Other name:
METTL-3 Inhibitor
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- > 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 Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Honor Health
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
South Texas Accelerated Research Therapeutics
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Start date:
November 15, 2022
Completion date:
March 30, 2025
Lead sponsor:
Agency:
STORM Therapeutics LTD
Agency class:
Industry
Source:
STORM Therapeutics LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05584111
