Oral Administration of STC-15 in Subjects With Advanced Malignancies

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

42 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Other measures

Research locations (3)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

3 locations

Study team and timeline

Lead sponsor

STORM Therapeutics LTD

Study start

Nov 15, 2022 Actual

Primary completion

Aug 30, 2024 Actual

Study completion

Dec 22, 2024 Actual

First posted

Oct 18, 2022 Actual

Last updated

Nov 9, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.