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NCT05584111 · ClinicalTrials.gov registry record · Phase 1

Oral Administration of STC-15 in Subjects With Advanced Malignancies

A Phase 1 study of Cancer and Advanced Solid Tumor, sponsored by STORM Therapeutics.

Completed
Registry status
Phase 1
Development phase
42
Enrollment target
3
Study locations

NCT05584111 is a Phase 1 study of Cancer and Advanced Solid Tumor that has completed, run by STORM Therapeutics. The registered enrollment target is 42 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT05584111, a Phase 1 study of Cancer and Advanced Solid Tumor, has completed, sponsored by STORM Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
42 participants
Enrollment target
3
Study locations

Study 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. 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.

Interventions

  • DRUG STC-15

Study Locations (3)

Texas

  • The University of Texas MD Anderson Cancer Center - Houston
  • South Texas Accelerated Research Therapeutics - San Antonio

Arizona

  • Honor Health - Scottsdale

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2022-11-15
Est. Completion 2024-12-22
Phase Phase 1

Sponsor

STORM Therapeutics

2 total trials

What the Registry Record Tells You About NCT05584111

The ClinicalTrials.gov registry entry for NCT05584111 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The listed sponsor is STORM Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which STC-15 is the first listed.

NCT05584111 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Texas, Arizona.

Frequently Asked Questions

What is clinical trial NCT05584111 about?

NCT05584111 is a clinical study titled "Oral Administration of STC-15 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, p...

What is the current status of trial NCT05584111?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2022-11-15. Estimated completion is 2024-12-22.

What conditions does trial NCT05584111 study?

This clinical trial studies the following conditions: Cancer, Advanced Solid Tumor, Advanced Cancer.

What interventions are being tested in trial NCT05584111?

The interventions under investigation include: STC-15 (DRUG).

Who is sponsoring clinical trial NCT05584111?

This trial is sponsored by STORM Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05584111 being conducted?

This trial has 3 study locations across Arizona, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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