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NCT04561362 · ClinicalTrials.gov registry record · Phase 1

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

A Phase 1 study of Advanced Solid Tumor and Breast Neoplasms, sponsored by BicycleTx Limited.

Active
Registry status
Phase 1
Development phase
329
Enrollment target
20
Study locations

NCT04561362 is a Phase 1 study of Advanced Solid Tumor and Breast Neoplasms that is active but no longer recruiting, run by BicycleTx Limited. The registered enrollment target is 329 participants, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (72% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT04561362, a Phase 1 study of Advanced Solid Tumor and Breast Neoplasms, is active but no longer recruiting, sponsored by BicycleTx Limited.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
329 participants
Enrollment target
20
Study locations

Study Summary

This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are: Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Parts B1-B7), Safety and tolerability (Parts B-8, B-9 and C), and characterization of the pharmacokinetics (Part D).

Conditions Studied

Advanced Solid Tumor Breast Neoplasms Triple Negative Breast Neoplasms Ovarian Neoplasm Urinary Bladder Neoplasm Hormone Receptor Positive, HER2-negative Neoplasms Hormone Receptor Positive, HER2-low Neoplasms Non-Small-Cell Lung Neoplasms

Interventions

  • DRUG Pembrolizumab
  • DRUG BT8009

Study Locations (20)

Other

  • Institut Bergonie - Bordeaux
  • Centre Leon Berard - Lyon
  • Institut Paoli-Calmettes - Marseille
  • Centre Eugene Marquis - Rennes
  • Institut Gustave Roussy - Villejuif
  • Ospedale San Raffaele - Milan
  • Vall d'Hebron Institute of Oncology - Barcelona
  • Hospital Clinic de Barcelona - Barcelona
  • START Madrid Fundacion Jimenez Diaz - Madrid

Florida

  • Ocala Oncology Center - Ocala
  • Advent Health - Orlando

Texas

  • Mary Crowley Cancer Research Center - Dallas
  • The University of Texas MD Anderson Cancer Center - Houston

Colorado

  • Sarah Cannon Research Institute at HealthONE - Denver

New York

  • Icahn School of Medicine at Mount Sinai - New York

Ohio

  • University Hospitals Cleveland Medical Center - Cleveland

Pennsylvania

  • Thomas Jefferson University, Sidney Kimmel Cancer Center - Philadelphia

Tennessee

  • Tennessee Oncology, PLLC - Nashville

Trial Details

FieldValue
Enrollment Target 329 participants
Start Date 2020-07-17
Est. Completion 2026-12
Phase Phase 1

Sponsor

BicycleTx Limited

7 total trials

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What the Registry Record Tells You About NCT04561362

The ClinicalTrials.gov registry entry for NCT04561362 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 329 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (72% higher). The listed sponsor is BicycleTx Limited, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 8 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT04561362 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT04561362 about?

NCT04561362 is a clinical study titled "Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies". This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies h...

What is the current status of trial NCT04561362?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 329 participants. The study started on 2020-07-17. Estimated completion is 2026-12.

What conditions does trial NCT04561362 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Breast Neoplasms, Triple Negative Breast Neoplasms, Ovarian Neoplasm, Urinary Bladder Neoplasm.

What interventions are being tested in trial NCT04561362?

The interventions under investigation include: Pembrolizumab (DRUG), BT8009 (DRUG).

Who is sponsoring clinical trial NCT04561362?

This trial is sponsored by BicycleTx Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04561362 being conducted?

This trial has 20 study locations across Colorado, Florida, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.