Oral STC-15 for Advanced Cancer

No longer recruiting at 2 trial locations

Overseen By Melinda Snyder

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: STORM Therapeutics LTD

Must not be taking: Antineoplastics, Immunotherapy

Disqualifiers: CNS disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, STC-15, for individuals with advanced cancer who have exhausted standard treatments or opted not to continue them. The study aims to determine the safest and most effective dose of STC-15 by exploring different dosing schedules. Participants will receive capsules in three-week cycles, and researchers will closely monitor how the body processes the drug and any effects it produces. This trial suits those with advanced cancer who have tried all available treatments and maintain good organ function. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial requires that you stop any local or systemic cancer treatments at least 3 weeks before starting the study medication. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that STC-15 is likely to be safe for humans?

Studies have shown that STC-15 is generally well tolerated by patients with advanced cancer. Research indicates that it does not cause severe side effects, even at varying dose levels. In previous studies, participants reported few serious adverse events, suggesting that the treatment is generally safe. Although the current trial is in its early stages and primarily focuses on safety, earlier research supports the idea that STC-15 is a promising and safe option. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments that often involve chemotherapy or radiation, STC-15 is unique because it is an oral medication, making it potentially easier and more convenient for patients to take. Researchers are excited about STC-15 because it targets cancer cells with a novel mechanism that might offer a different approach compared to existing therapies. Additionally, the varying dosing schedules being explored, such as daily or every other day, could provide options to tailor treatment to individual patient needs while potentially reducing side effects.

What evidence suggests that STC-15 might be an effective treatment for advanced cancer?

Research shows that STC-15 holds promise in treating advanced cancers. Studies have found that STC-15 is generally well tolerated, causing few side effects. It blocks an enzyme called METTL3, which aids cancer cell growth. Early results suggest this can slow or stop tumor growth in various cancers. In this trial, researchers will test STC-15 at different dose levels, with positive results seen across multiple cancer types. This makes STC-15 a hopeful option for people with advanced cancers. ^{1 2 4 5 6}

Who Is on the Research Team?

Josefin Holz

Principal Investigator

STORM Therapeutics

Are You a Good Fit for This Trial?

Adults over 18 with advanced cancers that haven't responded to standard treatments can join this trial. They should be relatively active and have good organ function. People who've had recent major surgery, radiation, or other cancer therapies, those with autoimmune diseases needing treatment in the last 2 years, or a history of severe brain-related side effects from drugs cannot participate.

Inclusion Criteria

I am fully active or can carry out light work.

My advanced cancer has not responded to standard treatments, and I have no other standard options or have chosen not to pursue them.

My organs and bone marrow are working well.

Exclusion Criteria

I have not had major surgery or radiation in the last 3 weeks.

I have had severe brain-related side effects from drugs or have brain involvement in my disease.

I have been treated for an autoimmune disease in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending daily oral doses of STC-15 in 3-week treatment cycles

6 months

Visits every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• STC-15

Trial Overview

The trial is testing STC-15, an oral medication for various advanced cancers. It's given in cycles every three weeks using a specific plan to increase doses safely. The study will look at how well it works and its effects on the body alongside potential use with approved cancer treatments.

How Is the Trial Designed?

Group I: Dose Level 5 Experimental Treatment 1 Intervention

30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles

Group II: Dose Level 4 Experimental Treatment 1 Intervention

30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles

Group III: Dose Level 3 Experimental Treatment 1 Intervention

100mg capsules, MWF administration for 3 week (21 day) cycles

Group IV: Dose Level 2 Experimental Treatment 1 Intervention

30mg capsules, MWF administration for 3 week (21 day) cycles

Group V: Dose Level 1 Experimental Treatment 1 Intervention

30mg capsules, daily administration for 3 week (21 day) cycles

Who Is Running the Clinical Trial?

STORM Therapeutics LTD

Lead Sponsor

Trials

1

Recruited

40+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06975293

NCT06975293 | STC-15 as a Part of Combination Therapy ...

This early phase oncology trial will be conducted at various study centers to investigate the safety, tolerability, and antitumor activity of STC-15 (a ...

2.

stormtherapeutics.com

stormtherapeutics.com/news/press-releases/storm-therapeutics-presents-new-clinical-data-on-its-first-in-class-mettl3-inhibitor-stc-15-at-sitc-2024/

Harnessing the power of RNA epigenetics | Cambridge, UK

STC-15 is well tolerated and demonstrates promising signs of clinical activity observed in multiple tumor types. Gene expression data shows ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2586

Phase 1 dose escalation and cohort expansion study ...

Treatment with STC-15 is well tolerated across pharmacologically active dose range with encouraging signs of clinical activity.

4.

cancerresearchhorizons.com

cancerresearchhorizons.com/news-and-events/our-news/storm-therapeutics-announces-first-patient-dosed-clinical-collaboration

STORM Therapeutics announces first patient dosed in ...

Final clinical results from a Phase 1 study of STC-15 in patients with advanced malignancies demonstrated that it is well tolerated and ...

5.

targetedonc.com

targetedonc.com/view/novel-mettl3-inhibitor-elicits-clinical-activity-across-tumor-types

Novel METTL3 Inhibitor Elicits Clinical Activity Across ...

STC-15, an investigational RNA methyltransferase inhibitor, has shown promising clinical activity and an encouraging safety profile across various tumor types.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05584111?term=NCT05584111&rank=1

Oral Administration of STC-15 in Subjects With Advanced ...

The study is designed to systematically assess safety and tolerability, pharmacokinetics, pharmacodynamics and clinical activity of STC-15 in adult subjects ...