Oral Administration of STC-15 in Subjects With Advanced Malignancies

ClinicalTrials.gov ID: NCT05584111

Public ClinicalTrials.gov record NCT05584111. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 9:17 PM EDT

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT05584111
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: STORM Therapeutics LTD; Industry
Enrollment: 42 participants

Conditions and interventions

Conditions

Interventions

STC-15 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 14, 2022
Primary completion: Aug 29, 2024
Completion: Dec 21, 2024
Last update posted: Mar 25, 2025

2022 – 2024

United States locations

U.S. sites: 3
U.S. states: 2
U.S. cities: 3

Facility	City	State	ZIP	Site status
Honor Health	Scottsdale	Arizona	85258	—
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	—
South Texas Accelerated Research Therapeutics	San Antonio	Texas	78229	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05584111, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 25, 2025 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05584111 live on ClinicalTrials.gov.

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