Oral Administration of STC-15 in Subjects with Advanced Malignancies

March 23, 2025 updated by: STORM Therapeutics LTD

Phase 1 Study to Evaluate the Safety, PK, PD, and Clinical Activity of STC-15, a METTL-3 Inhibitor, 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • METTL-3 Inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Screening through end of treatment, approximately 6 months
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.
Screening through Cycle 2 (each cycle is 21 days)
Tmax (PK)
Time Frame: Screening through Cycle 2 (each cycle is 21 days)
To determine the time to Cmax (Tmax)
Screening through Cycle 2 (each cycle is 21 days)
Ctrough (PK)
Time Frame: Screening through end of treatment, approximately 6 months
To determine observed trough serum concentration (Ctrough)
Screening through end of treatment, approximately 6 months
Terminal elimination half life (PK)
Time Frame: Screening through Cycle 2 (each cycle is 21 days)
To determine the terminal elimination half-life (t½)
Screening through Cycle 2 (each cycle is 21 days)
AUC (PK)
Time Frame: Screening through Cycle 2 (each cycle is 21 days)
To determine AUC in 1 dosing interval
Screening through Cycle 2 (each cycle is 21 days)
Average concentration (PK)
Time Frame: Screening through Cycle 2 (each cycle is 21 days)
To determine the average concentration over a dosing interval
Screening through Cycle 2 (each cycle is 21 days)
Systemic Clearance (PK)
Time Frame: Screening through Cycle 2 (each cycle is 21 days)
To determine the systemic clearance
Screening through Cycle 2 (each cycle is 21 days)
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)
Screening through Cycle 2 (each cycle is 21 days)
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
Screening through end of treatment, approximately 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy as measured by RECIST 1.1 (DoR)
Time Frame: Screening through disease progression, approximately 6 months
Determine the duration of response (DoR)
Screening through disease progression, approximately 6 months
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).
Screening through disease progression, approximately 6 months
Efficacy as measured by RECIST 1.1 (DCR)
Time Frame: Screening through disease progression, approximately 6 months
Determine the disease control rate (DCR)
Screening through disease progression, approximately 6 months
Efficacy as measured by RECIST 1.1 (ORR)
Time Frame: Screening through disease progression, approximately 6 months
Determine the objective response rate (ORR)
Screening through disease progression, approximately 6 months
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
Screening through 90 days after the last dose of STC-15, approximately 9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Screening through Cycle 2 (each cycle is 21 days)
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
Screening through Cycle 2 (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
STORM Therapeutics LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Josefin Holz, Storm Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STC15-22101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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