Oral STC-15 for Advanced Cancer

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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Josefin Holz

Principal Investigator

STORM Therapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+