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Trial record 1 of 1 for:    stc-15
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Oral Administration of STC-15 in Subjects With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT05584111
Recruitment Status : Recruiting
First Posted : October 18, 2022
Last Update Posted : January 23, 2024
Sponsor:
Information provided by (Responsible Party):
STORM Therapeutics LTD

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Advanced Solid Tumor Cancer Drug: STC-15 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2022
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : May 30, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Level 1
30mg capsules, daily administration for 3 week (21 day) cycles
 Drug: STC-15
STC-15 oral capsules various dosing regimen in 3-week cycles
Other Name: METTL-3 Inhibitor
Experimental: Dose Level 2
30mg capsules, MWF administration for 3 week (21 day) cycles
 Drug: STC-15
STC-15 oral capsules various dosing regimen in 3-week cycles
Other Name: METTL-3 Inhibitor
Experimental: Dose Level 3
100mg capsules, MWF administration for 3 week (21 day) cycles
 Drug: STC-15
STC-15 oral capsules various dosing regimen in 3-week cycles
Other Name: METTL-3 Inhibitor
Experimental: Dose Level 4
30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles
 Drug: STC-15
STC-15 oral capsules various dosing regimen in 3-week cycles
Other Name: METTL-3 Inhibitor
Experimental: Dose Level 5
30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles
 Drug: STC-15
STC-15 oral capsules various dosing regimen in 3-week cycles
Other Name: METTL-3 Inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Screening through end of treatment, approximately 6 months ]
    To evaluate the incidence, severity, and duration of adverse events

  2. Cmax (PK) [ Time Frame: 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.

  3. Tmax (PK) [ Time Frame: Screening through Cycle 2 (each cycle is 21 days) ]
    To determine the time to Cmax (Tmax)

  4. Ctrough (PK) [ Time Frame: Screening through end of treatment, approximately 6 months ]
    To determine observed trough serum concentration (Ctrough)

  5. Terminal elimination half life (PK) [ Time Frame: Screening through Cycle 2 (each cycle is 21 days) ]
    To determine the terminal elimination half-life (t½)

  6. AUC (PK) [ Time Frame: Screening through Cycle 2 (each cycle is 21 days) ]
    To determine AUC in 1 dosing interval

  7. Average concentration (PK) [ Time Frame: Screening through Cycle 2 (each cycle is 21 days) ]
    To determine the average concentration over a dosing interval

  8. Systemic Clearance (PK) [ Time Frame: Screening through Cycle 2 (each cycle is 21 days) ]
    To determine the systemic clearance

  9. Volume of distribution at steady-state (PK) [ Time Frame: Screening through Cycle 2 (each cycle is 21 days) ]
    To determine the volume of distribution at steady-state (Vss)

  10. Accumulation ratio from first dose to steady-state (PK) [ Time Frame: Screening through end of treatment, approximately 6 months ]
    To determine the accumulation ratio from first dose to steady-state


Secondary Outcome Measures :
  1. Efficacy as measured by RECIST 1.1 (DoR) [ Time Frame: Screening through disease progression, approximately 6 months ]
    Determine the duration of response (DoR)

  2. Efficacy as measured by RECIST 1.1 (PFS) [ Time Frame: Screening through disease progression, approximately 6 months ]
    Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS).

  3. Efficacy as measured by RECIST 1.1 (DCR) [ Time Frame: Screening through disease progression, approximately 6 months ]
    Determine the disease control rate (DCR)

  4. Efficacy as measured by RECIST 1.1 (ORR) [ Time Frame: Screening through disease progression, approximately 6 months ]
    Determine the objective response rate (ORR)

  5. Recommended Phase 2 Dose (RP2D) [ Time Frame: Screening through 90 days after the last dose of STC-15, approximately 9 months ]
    determine the RP2D for STC-15


Other Outcome Measures:
  1. Assessment of m6A modification of mRNA from peripheral blood [ Time Frame: Screening through Cycle 2 (each cycle is 21 days) ]
    To evaluate the effect of STC-15 on METTL3 enzymatic activity

  2. Assessment of serum cytokines levels [ Time Frame: Screening through Cycle 2 (each cycle is 21 days) ]
    To evaluate immunologic biomarkers in blood and tumor tissue


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05584111


Contacts
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Contact: Melinda Snyder 617-233-4057 melinda.snyder@stormtherapeutics.com

Locations
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United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Mei Yu       myu@honorhealth.com   
Principal Investigator: Justin Moser, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jordi Rodon Ahnert, M.D., PhD    713-792-5603      
Principal Investigator: Jordi Rodon Ahnert, M.D., PhD         
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez    210-593-5265    Jimenez@startda.com   
Principal Investigator: Kyriakos Papadopoulos, MD         
Sponsors and Collaborators
STORM Therapeutics LTD
Investigators
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Study Director: Josefin Holz STORM Therapeutics
More Information
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Responsible Party: STORM Therapeutics LTD
ClinicalTrials.gov Identifier: NCT05584111    
Other Study ID Numbers: STC15-22101
First Posted: October 18, 2022    Key Record Dates
Last Update Posted: January 23, 2024
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by STORM Therapeutics LTD:
Oncology
METTL-3 Inhibitor
Additional relevant MeSH terms:
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Neoplasms