Advanced CancerPhase 1NCT05584111
Oral Administration of STC-15 in Subjects With Advanced Malignancies
A Phase 1 study testing STC-15 in people with Advanced Cancer and Advanced Solid Tumor, run by STORM Therapeutics LTD at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Advanced Solid Tumor, Cancer
- What is being tested?
- STC-15
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Nov 2022to 22 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Honor Health
Scottsdale, Arizona, 85258
About this study
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
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.
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Cancer
- Being tested
- STC-15
- Keywords
- Oncology, METTL-3 Inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STC-15Drug
Also called METTL-3 Inhibitor
STC-15 oral capsules various dosing regimen in 3-week cycles
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | 30mg capsules, daily administration for 3 week (21 day) cycles Receives: Drug: STC-15 |
| Dose Level 2 | Experimental | 30mg capsules, MWF administration for 3 week (21 day) cycles Receives: Drug: STC-15 |
| Dose Level 3 | Experimental | 100mg capsules, MWF administration for 3 week (21 day) cycles Receives: Drug: STC-15 |
| Dose Level 4 | Experimental | 30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles Receives: Drug: STC-15 |
| Dose Level 5 | Experimental | 30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles Receives: Drug: STC-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
To evaluate the incidence, severity, and duration of adverse events
Measured: Screening through end of treatment, approximately 6 months
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.
Measured: Screening through Cycle 2 (each cycle is 21 days)
Tmax (PK)
To determine the time to Cmax (Tmax)
Measured: Screening through Cycle 2 (each cycle is 21 days)
Ctrough (PK)
To determine observed trough serum concentration (Ctrough)
Measured: Screening through end of treatment, approximately 6 months
Terminal elimination half life (PK)
To determine the terminal elimination half-life (t½)
Measured: Screening through Cycle 2 (each cycle is 21 days)
AUC (PK)
To determine AUC in 1 dosing interval
Measured: Screening through Cycle 2 (each cycle is 21 days)
Average concentration (PK)
To determine the average concentration over a dosing interval
Measured: Screening through Cycle 2 (each cycle is 21 days)
Systemic Clearance (PK)
To determine the systemic clearance
Measured: Screening through Cycle 2 (each cycle is 21 days)
Volume of distribution at steady-state (PK)
To determine the volume of distribution at steady-state (Vss)
Measured: Screening through Cycle 2 (each cycle is 21 days)
Accumulation ratio from first dose to steady-state (PK)
To determine the accumulation ratio from first dose to steady-state
Measured: Screening through end of treatment, approximately 6 months
Secondary outcomes (5)
Efficacy as measured by RECIST 1.1 (DoR)
Determine the duration of response (DoR)
Measured: Screening through disease progression, approximately 6 months
Efficacy as measured by RECIST 1.1 (PFS)
Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS).
Measured: Screening through disease progression, approximately 6 months
Efficacy as measured by RECIST 1.1 (DCR)
Determine the disease control rate (DCR)
Measured: Screening through disease progression, approximately 6 months
Efficacy as measured by RECIST 1.1 (ORR)
Determine the objective response rate (ORR)
Measured: Screening through disease progression, approximately 6 months
Recommended Phase 2 Dose (RP2D)
determine the RP2D for STC-15
Measured: Screening through 90 days after the last dose of STC-15, approximately 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start15 Nov 2022
- Primary completion30 Aug 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- STORM Therapeutics LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josefin Holz, Study director, STORM Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584111
- Sponsor's protocol ID
- STC15-22101
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05584111
- Acronym / sponsor ID
- STC15-22101
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Cancer
- Keywords
- Oncology, METTL-3 Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- STORM Therapeutics LTDIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: STC-1530mg capsules, daily administration for 3 week (21 day) cycles |
| Dose Level 2 | Experimental | Drug: STC-1530mg capsules, MWF administration for 3 week (21 day) cycles |
| Dose Level 3 | Experimental | Drug: STC-15100mg capsules, MWF administration for 3 week (21 day) cycles |
| Dose Level 4 | Experimental | Drug: STC-1530mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles |
| Dose Level 5 | Experimental | Drug: STC-1530mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STC-15Also: METTL-3 InhibitorSTC-15 oral capsules various dosing regimen in 3-week cycles | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5 |
Primary outcome
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
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.
Tmax (PK)
Time frame: Screening through Cycle 2 (each cycle is 21 days)
To determine the time to Cmax (Tmax)
Ctrough (PK)
Time frame: Screening through end of treatment, approximately 6 months
To determine observed trough serum concentration (Ctrough)
Terminal elimination half life (PK)
Time frame: Screening through Cycle 2 (each cycle is 21 days)
To determine the terminal elimination half-life (t½)
AUC (PK)
Time frame: Screening through Cycle 2 (each cycle is 21 days)
To determine AUC in 1 dosing interval
Average concentration (PK)
Time frame: Screening through Cycle 2 (each cycle is 21 days)
To determine the average concentration over a dosing interval
Systemic Clearance (PK)
Time frame: Screening through Cycle 2 (each cycle is 21 days)
To determine the systemic clearance
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)
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
5 secondary outcomes
Efficacy as measured by RECIST 1.1 (DoR)
Time frame: Screening through disease progression, approximately 6 months
Efficacy as measured by RECIST 1.1 (PFS)
Time frame: Screening through disease progression, approximately 6 months
Efficacy as measured by RECIST 1.1 (DCR)
Time frame: Screening through disease progression, approximately 6 months
Efficacy as measured by RECIST 1.1 (ORR)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josefin Holz study director
STORM Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STC-15 in people with Advanced Cancer and Advanced Solid Tumor, run by STORM Therapeutics LTD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Screening through end of treatment, approximately 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.