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NCT04478279 · ClinicalTrials.gov registry record · Phase 1

A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors

A Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by Sapience Therapeutics.

Active
Registry status
Phase 1
Development phase
125
Enrollment target
11
Study locations

NCT04478279 is a Phase 1 study of Breast Cancer and Prostate Cancer that is active but no longer recruiting, run by Sapience Therapeutics. The registered enrollment target is 125 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 11 study locations across 8 states.

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The verdict

NCT04478279, a Phase 1 study of Breast Cancer and Prostate Cancer, is active but no longer recruiting, sponsored by Sapience Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
125 participants
Enrollment target
11
Study locations

Study Summary

This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

Conditions Studied

Breast Cancer Prostate Cancer Glioblastoma Metastatic Breast Cancer Metastatic Melanoma Glioblastoma Multiforme Brain Cancer Metastatic Prostate Cancer GBM Melanoma Stage IV

Interventions

  • DRUG Temozolomide
  • RADIATION Radiation
  • DRUG ST101

Study Locations (11)

Other

  • Edinburgh Cancer Centre - Edinburgh
  • The Beaston West of Scotland Cancer Centre - Glasgow
  • University of Leeds - Leeds
  • Sarah Cannon Research Institute UK - London

California

  • University of California, San Francisco - San Francisco

Colorado

  • Sarah Cannon Research Institute - Denver

Illinois

  • Northwestern Medicine Cancer Centers - Warrenville

Michigan

  • START Midwest - Grand Rapids

New York

  • Columbia University - New York

North Carolina

  • Duke University School of Medicine - Durham

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2020-07-01
Est. Completion 2026-12
Phase Phase 1

Sponsor

Sapience Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04478279

The ClinicalTrials.gov registry entry for NCT04478279 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Sapience Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.

NCT04478279 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Other, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT04478279 about?

NCT04478279 is a clinical study titled "A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors". This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase a...

What is the current status of trial NCT04478279?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2020-07-01. Estimated completion is 2026-12.

What conditions does trial NCT04478279 study?

This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Glioblastoma, Metastatic Breast Cancer, Metastatic Melanoma.

What interventions are being tested in trial NCT04478279?

The interventions under investigation include: Temozolomide (DRUG), Radiation (RADIATION), ST101 (DRUG).

Who is sponsoring clinical trial NCT04478279?

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

Where is trial NCT04478279 being conducted?

This trial has 11 study locations across California, Colorado, Illinois, Michigan, New York. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.