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

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

Safety reported as incidence of treatment-emergent adverse events using CTCAE v5.0 criteria.

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
BicycleTx Limited

7 total trials

What the registry record for NCT04561362 still lists

NCT04561362 is an interventional study that assigns participants to a tested intervention. The registered 329 participants enrollment target is mid-sized for trials with a published cap, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (72% higher).

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 names 20 study sites across 10 states, led by 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.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04561362's enrollment target sits among peer trials

329 29th of 189 higher than 161 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04561362, the US trial registry maintained by the National Library of Medicine. NCT04561362 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.