Zelenectide Pevedotin

DRUG7 trials

Sponsors

Bicycletx Limited, BicycleTx Limited

Conditions

Advanced Solid TumorsAdvanced or Metastatic Non-small Cell Lung CancerLocally advanced or metastatic urothelial cancerMetastatic Urothelial CancerNECTIN4 Amplified Advanced Breast CancerNectin-4 Expressing Advanced Malignancies.Non-Small Cell Lung Cancer

Phase 1

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

Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Active, not recruitingNCT06225596

BicycleTx LimitedMetastatic Urothelial Cancer

Start: 2024-01-24End: 2028-03-01Target: 375Updated: 2026-05-27

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

Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

Active, not recruitingNCT06933329

BicycleTx LimitedNon-Small Cell Lung Cancer

Start: 2025-07-18End: 2029-02-28Target: 73Updated: 2026-04-15

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

Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product

Not yet recruitingNCT07681674

BicycleTx LimitedAdvanced Solid Tumors

Start: 2026-08-01End: 2030-05-30Target: 16Updated: 2026-07-02

Related Papers

Interim analysis results from Duravelo-2: Zelenectide pevedotin (zele; BT8009) in patients (pts) with previously treated locally advanced/metastatic urothelial carcinoma (la/mUC).

Journal of Clinical Oncology2026-05-27

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

Interim analysis results from Duravelo-2: Zelenectide pevedotin (zele; BT8009) + pembrolizumab in patients (pts) with previously untreated locally advanced/metastatic urothelial carcinoma (la/mUC).

Journal of Clinical Oncology2026-05-27

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

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