Skip to main content
OpenTrials
Completed

NCT Number: NCT05584111

Oral Administration of STC-15 in Subjects With Advanced Malignancies

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Cancer Advanced Solid Tumor Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Honor Health, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STC-15

Drug

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

Other names: METTL-3 Inhibitor

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

STORM Therapeutics LTD

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.