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Be Part of Research - Trial Details - Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
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Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

London Manchester

Medical Conditions

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

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2020 Mar 2026

Publications

"Baldini C, Verlingue L, Goldschmidt V, Doger de Speville B, Lostes J, Italiano A, Cousin S, Falchook GS, Necchi A, Reig Torras O, Fontana E, Carter L, Rodon Ahnert J, Brown JR, DeMars LR, Josephs K, Dickson A, Xu C, Bader J, Campbell C, Sharma R, McKean M. First-in-Human, Phase I/II Dose Escalation and Expansion Study of Zelenectide Pevedotin in Patients With Advanced Solid Tumors: Results From Monotherapy Dose Escalation. J Clin Oncol. 2025 Nov 6:JCO2500559. doi: 10.1200/JCO-25-00559. Online ahead of print."; "41197088"; "Klumper N, Eckstein M, Holzel M, Herrmann K, Hadaschik B, Grunwald V. Re: First-in-Human Study of the Radioligand 68Ga-N188 Targeting Nectin-4 for PET/CT Imaging of Advanced Urothelial Carcinoma: Navigating Metastatic Urothelial Cancer with Nectin-4 PET/CT. Eur Urol. 2023 Nov;84(5):514-515. doi: 10.1016/j.eururo.2023.05.029. Epub 2023 Jun 5. No abstract available."; "37286457"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Bicyclic Toxin Conjugate (BTC) administered either weekly (i.e., on Days 1, 8, 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle for participants in A-1. Participants in Cohorts A-2 and B-7 will receive BT8009 weekly on 21-day cycle. Participants in Parts B-1-B-6 will receive BT8009 weekly either on a 21-day or 28-day cycle. Participants in Parts B-8 and B-9 will receive BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive BT8009 once weekly (i.e., on Days 1, 8, 15, and 22) on a 28-day cycle. Participants in Part D will receive BT8009 once weekly on a 28-day cycle.

Intervention Arm Group : Cohort B-1 - BT8009 Monotherapy Dose Expansion;Cohort B-2- BT8009 Monotherapy Dose Expansion;Cohort B-3- BT8009 Monotherapy Dose Expansion;Cohort B-4- BT8009 Monotherapy Dose Expansion;Cohort B-5- BT8009 Monotherapy Dose Expansion;Cohort B-6- BT8009 Monotherapy Dose Expansion;Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion;Part A-1 -BT8009 Monotherapy Dose Escalation;Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation;Part B-8 - BT8009 Monotherapy Dose Expansion;Part B-9 - BT8009 Monotherapy Dose Expansion;Part C - Renal Insufficiency BT8009 Monotherapy Dose Expansion;Part D - BT8009 Monotherapy Supplementary PK;

Intervention Type : DRUG
Intervention Description : Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each Q3W.

Intervention Arm Group : Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion;Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Sarah Cannon Research Institute UK
    London
    W1G 6AD
  • The Christie NHS Foundation Trust
    Manchester
    M20 4BX


The study is sponsored by BicycleTx Limited



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Read full details for Trial ID: NCT04561362
Last updated 13 November 2025

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