BT8009

DRUG6 trials

Sponsors

Bicycletx Limited, BicycleTx Limited

Conditions

Advanced Solid TumorAdvanced or Metastatic Non-small Cell Lung CancerBreast NeoplasmsHormone Receptor Positive, HER2-low NeoplasmsHormone Receptor Positive, HER2-negative NeoplasmsLocally advanced or metastatic urothelial cancerNECTIN4 Amplified Advanced Breast CancerNectin-4 Expressing Advanced Malignancies.

Phase 1

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

Active, not recruitingNCT04561362

BicycleTx LimitedAdvanced Solid Tumor, Breast Neoplasms, Hormone Receptor Positive, HER2-low Neoplasms +5

Start: 2020-07-17End: 2026-12-31Target: 329Updated: 2025-11-14

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies.

Active, not recruitingCTIS2023-509781-37-00

Bicycletx LimitedNectin-4 Expressing Advanced Malignancies.

Start: 2021-04-12Target: 254Updated: 2026-01-19

Phase 2

A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

WithdrawnCTIS2023-504231-41-00

Bicycletx LimitedLocally advanced or metastatic urothelial cancer

Target: 48Updated: 2024-04-16

A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

RecruitingCTIS2023-504231-41-01

Bicycletx LimitedLocally advanced or metastatic urothelial cancer

Start: 2024-10-02Target: 624Updated: 2026-01-27

Phase 2 Study of Zelenectide Pevedotin in Participants with NECTIN4 Amplified Advanced Breast Cancer

RecruitingCTIS2024-517868-33-00

Bicycletx LimitedNECTIN4 Amplified Advanced Breast Cancer

Start: 2025-06-12Target: 30Updated: 2025-11-17

Phase 2 Study of Zelenectide Pevedotin in Participants with Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

RecruitingCTIS2025-521115-40-00

Bicycletx LimitedAdvanced or Metastatic Non-small Cell Lung Cancer

Start: 2025-09-30Target: 28Updated: 2026-01-27

Related Papers

Identifying optimized dosage for zelenectide pevedotin in locally advanced/metastatic urothelial carcinoma (la/mUC) using quantitative analyses.

Journal of Clinical Oncology2026-05-27

Zelenectide pevedotin (BT8009) monotherapy in previously treated metastatic urothelial carcinoma (mUC): Update on Duravelo-1.

Journal of Clinical Oncology2026-05-27

Zelenectide pevedotin (BT8009) plus pembrolizumab in 1L cisplatin-ineligible locally advanced/metastatic urothelial carcinoma: Update on Duravelo-1 B7.

Journal of Clinical Oncology2026-05-27

Abstract 7227: <i>NECTIN4-a</i> mplified breast cancer targeted by Zelenectide Pevedotin: Amplification and expression are frequent, concordant, and stable

Cancer Research2026-04-03

PS5-09-23: A Phase 2 study of zelenectide pevedotin, a Bicycle Drug Conjugate, in patients with NECTIN4 amplified advanced breast cancer (Duravelo-3)

Clinical Cancer Research2026-02-17

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.

2025-11-06

Abstract P4-10-21: Enhanced anti-tumor activity of zelenectide pevedotin in triple negative breast cancer (TNBC) patients (pts) with NECTIN4 gene amplification (amp)

Clinical Cancer Research2025-06-133 citations

Phase 1/2 Duravelo-1 study: Preliminary results of nectin-4–targeting zelenectide pevedotin (BT8009) plus pembrolizumab in previously untreated, cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer.

Journal of Clinical Oncology2025-05-283 citations

A phase 2/3 study of bicycle toxin conjugate zelenectide pevedotin (BT8009) targeting nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC; Duravelo-2).

Journal of Clinical Oncology2025-05-281 citations

A phase 2/3 study of bicycle toxin conjugate zelenectide pevedotin (BT8009) targeting Nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC) (Duravelo-2).

Journal of Clinical Oncology2025-02-102 citations

The validation and clinical bioanalysis of the Bicycle® Toxin Conjugate zelenectide pevedotin in human plasma.

2025-01-19

A phase 2/3 study of Bicycle toxin conjugate BT8009 targeting nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2.

Journal of Clinical Oncology2024-06-018 citations

Breaking from the paradigm of antibody-drug conjugates: Evaluation of clinical pharmacokinetics and safety of bicycle toxin conjugates (BTCs).

Journal of Clinical Oncology2024-06-013 citations

Abstract B014: Characterization of Nectin-4 protein expression in non-small cell lung cancer patients

Molecular Cancer Therapeutics2023-12-01

BT8009-100: A phase I/II study of novel bicyclic peptide and MMAE conjugate BT8009 in patients (pts) with advanced malignancies associated with nectin-4 expression, including urothelial cancer (UC).

Journal of Clinical Oncology2023-02-2020 citations

Abstract CT025: BT8009-100 phase I/II study of novel bi-cyclic peptide and MMAE conjugate BT8009 in patients with advanced malignancies associated with nectin-4 expression

Cancer Research2022-06-153 citations

Abstract 1197: A multi tumor survey of Nectin-4 expression to guide BT8009 indication selection

Cancer Research2021-07-014 citations

Abstract 391: Molecular-based enrichment strategy for Nectin-4 targeted Bicycle toxin conjugate BT8009

Cancer Research2021-07-011 citations

Association of combined phase I/II study of a novel bicyclic peptide and MMAE conjugate BT8009 in patients with advanced malignancies with Nectin-4 expression.

Journal of Clinical Oncology2021-05-206 citations