Oral Administration of STC-15 in Subjects With Advanced Malignancies

Cancer Clinical Trial

Official title:

Phase 1 Study to Evaluate the Safety, PK, PD, and Clinical Activity of STC-15, a METTL-3 Inhibitor, in Subjects With Advanced Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05584111
• Other study ID #: STC15-22101
• Status: Recruiting
• Phase: Phase 1
• Start date: November 15, 2022
• Est. completion date: May 30, 2025

Study information

• Verified date: September 2023
• Source: STORM Therapeutics LTD
• Contact: Melinda Snyder
• Phone: 617-233-4057
• Email: melinda.snyder[@]stormtherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Advanced Solid Tumor
• Cancer
• Neoplasms

Intervention

Drug:
• STC-15
STC-15 oral capsules various dosing regimen in 3-week cycles

Locations

Country	Name	City	State
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas
United States	Honor Health	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
STORM Therapeutics LTD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of m6A modification of mRNA from peripheral blood	To evaluate the effect of STC-15 on METTL3 enzymatic activity	Screening through Cycle 2 (each cycle is 21 days)
Other	Assessment of serum cytokines levels	To evaluate immunologic biomarkers in blood and tumor tissue	Screening through Cycle 2 (each cycle is 21 days)
Primary	Number of participants with adverse events	To evaluate the incidence, severity, and duration of adverse events	Screening through end of treatment, approximately 6 months
Primary	Cmax (PK)	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.	Screening through Cycle 2 (each cycle is 21 days)
Primary	Tmax (PK)	To determine the time to Cmax (Tmax)	Screening through Cycle 2 (each cycle is 21 days)
Primary	Ctrough (PK)	To determine observed trough serum concentration (Ctrough)	Screening through end of treatment, approximately 6 months
Primary	Terminal elimination half life (PK)	To determine the terminal elimination half-life (t½)	Screening through Cycle 2 (each cycle is 21 days)
Primary	AUC (PK)	To determine AUC in 1 dosing interval	Screening through Cycle 2 (each cycle is 21 days)
Primary	Average concentration (PK)	To determine the average concentration over a dosing interval	Screening through Cycle 2 (each cycle is 21 days)
Primary	Systemic Clearance (PK)	To determine the systemic clearance	Screening through Cycle 2 (each cycle is 21 days)
Primary	Volume of distribution at steady-state (PK)	To determine the volume of distribution at steady-state (Vss)	Screening through Cycle 2 (each cycle is 21 days)
Primary	Accumulation ratio from first dose to steady-state (PK)	To determine the accumulation ratio from first dose to steady-state	Screening through end of treatment, approximately 6 months
Secondary	Efficacy as measured by RECIST 1.1 (DoR)	Determine the duration of response (DoR)	Screening through disease progression, approximately 6 months
Secondary	Efficacy as measured by RECIST 1.1 (PFS)	Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS).	Screening through disease progression, approximately 6 months
Secondary	Efficacy as measured by RECIST 1.1 (DCR)	Determine the disease control rate (DCR)	Screening through disease progression, approximately 6 months
Secondary	Efficacy as measured by RECIST 1.1 (ORR)	Determine the objective response rate (ORR)	Screening through disease progression, approximately 6 months
Secondary	Recommended Phase 2 Dose (RP2D)	determine the RP2D for STC-15	Screening through 90 days after the last dose of STC-15, approximately 9 months