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ACTIVE NOT RECRUITING Phase 1

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

NCT04561362 · View on ClinicalTrials.gov ↗

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).

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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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04561362

The ClinicalTrials.gov registry entry for NCT04561362 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 329 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BicycleTx Limited, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04561362 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04561362?

The interventions under investigation include: Pembrolizumab (DRUG), BT8009 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04561362?

This trial is sponsored by BicycleTx Limited, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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