Drugs / Zelenectide pevedotin
Zelenectide pevedotin
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04561362 | Jul 2020 → Mar 2026 overdue | hormone receptor-positive breast cancer, non-small cell lung carcinoma, ovarian neoplasm, triple-negative breast carcinoma +1 | BicycleTx Limited | Active not recruiting | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07681674 | Aug 2026 → May 2030 expected | cancer | BicycleTx Limited | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06933329 | Jul 2025 → Aug 2028 expected | non-small cell lung carcinoma | BicycleTx Limited | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06840483 | Mar 2025 → Jun 2028 expected | breast cancer | BicycleTx Limited | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06225596 | Jan 2024 → Mar 2028 expected | urothelial carcinoma | BicycleTx Limited | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | BicycleTx Limited | Results Bicycle Therapeutics to Present Initial Duravelo-2 Data at 2026 ASCO Annual Meeting bicycletherapeutics.com ↗
The optimal dose of zelenectide demonstrated a potentially differentiated safety profile with incidence rates approximately four-fold lower for skin reactions and half that for peripheral neuropathy as published for SOC |
| 2026-03-17 | BicycleTx Limited | Results Bicycle Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2025 Financial Results bicycletherapeutics.com ↗
We have successfully completed the dose selection portion of the Duravelo-2 trial and received regulatory alignment that the 6mg dose and schedule is optimal for zelenectide in mUC based on strong anti-tumor activity and its differentiated safety profile. |
| 2025-01-13 | BicycleTx Limited | Results Bicycle Therapeutics Announces Updated Topline Zelenectide Pevedotin Data and Highlights 2025 Strategic Priorities and Milestones bicycletherapeutics.com ↗
Updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab continue to show promising anti-tumor activity and a differentiated safety profile in first-line cisplatin-ineligible metastatic urothelial cancer |
| 2024-12-12 | BicycleTx Limited | Results Bicycle Therapeutics Announces Data Updates Across Zelenectide Pevedotin Program and Development Strategy Leveraging NECTIN4 Gene Amplification bicycletherapeutics.com ↗
Topline combination data for zelenectide pevedotin plus pembrolizumab in first-line metastatic urothelial cancer demonstrated a 60% overall response rate, in line with existing therapies |
| 2024-09-14 | BicycleTx Limited | Results Bicycle Therapeutics Presents Updated Clinical Results Across Oncology Pipeline at ESMO Congress 2024 bicycletherapeutics.com ↗
Updated monotherapy data for Nectin-4 targeting zelenectide pevedotin in metastatic urothelial cancer (mUC) showed a promising 45% overall response rate (ORR), 11.1 months median duration of response and a generally well-tolerated safety profile |
| 2023-12-14 | BicycleTx Limited | Results Bicycle Therapeutics Provides Data Updates for Three Clinical Programs and Strategy Overview at First R&D Day bicycletherapeutics.com ↗
Updated BT8009 clinical data continue to support promising response and differentiated safety profile in mUC as well as emerging clinical activity in additional tumor types beyond bladder |
| 2023-10-19 | BicycleTx Limited | Regulatory Bicycle Therapeutics Selected to Participate in FDA Program to Expedite Commercial Manufacturing Readiness of BT8009 for Metastatic Bladder Cancer bicycletherapeutics.com ↗
Bicycle Therapeutics (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that BT8009, the company’s lead investigational therapy in development to treat metastatic bladder (urothelial) cancer, has been selected to participate in the Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program recently launched by the U.S. Food and Drug Administration (FDA). |
| 2023-09-11 | BicycleTx Limited | Regulatory Bicycle Therapeutics Announces Expedited Development Plan for BT8009 in Metastatic Bladder Cancer bicycletherapeutics.com ↗
The company has aligned with the FDA on a Phase 2/3 registrational trial, called Duravelo-2, that has an innovative design allowing for potential accelerated approval in untreated (first-line) and previously treated (second-line plus) metastatic bladder cancer. |
| 2023-02-14 | BicycleTx Limited | Results Bicycle Therapeutics Announces Phase I Dose Escalation Results from Ongoing Phase I/II Study of BT8009 bicycletherapeutics.com ↗
50% overall response rate (ORR) and 75% clinical benefit rate, including one complete response in urothelial cancer at the 5 mg/m2 dose on an intent-to-treat (ITT) basis |
| 2023-01-04 | BicycleTx Limited | Regulatory Bicycle Therapeutics Announces FDA Fast Track Designation Granted to BT8009 for the Treatment of Adult Patients with Previously Treated Locally Advanced or Metastatic Urothelial Cancer bicycletherapeutics.com ↗ |
| 2022-11-08 | BicycleTx Limited | Results Bicycle Therapeutics Announces First Patient Dosed in BT8009 Phase II Expansion Cohorts and Provides Program Update bicycletherapeutics.com ↗ |
| 2022-09-19 | BicycleTx Limited | Results Bicycle Therapeutics Announces Publication of Article Highlighting Preclinical Data from BT8009 Program in Molecular Cancer Therapeutics bicycletherapeutics.com ↗
The data published in Molecular Cancer Therapeutics describe BT8009’s pre-clinical efficacy in a wide range of cell-derived xenograft and patient-derived xenograft tumor models, with full tumor regression frequently seen in large and small tumors. |
| 2022-04-11 | BicycleTx Limited | Results Bicycle Therapeutics Announces Interim BT8009 Phase I Clinical Trial Results at the 2022 AACR Annual Meeting bicycletherapeutics.com ↗
today announced interim Phase I results from the Phase I/II trial of BT8009, a second-generation BTC™ targeting Nectin-4. |
| 2022-01-05 | BicycleTx Limited | Results Bicycle Therapeutics Announces Continued Clinical Progress and Updates to Management Team bicycletherapeutics.com ↗
In our trial of BT8009, we are pleased to confirm the preliminary activity and see that these patients remain on trial. |
| 2021-10-07 | BicycleTx Limited | Results Bicycle Therapeutics Announces Interim BT5528 Phase I Clinical Trial Results and Preliminary Results from Ongoing BT8009 Phase I Clinical Trial bicycletherapeutics.com ↗
In the ongoing BT8009 Phase I trial in monotherapy cohorts, 4 out of 11 urothelial patients had partial responses; Phase I dose escalation remains ongoing, with no dose limiting toxicities (DLTs) yet observed |
| 2021-01-14 | BicycleTx Limited | Results Bicycle Therapeutics Announces Pipeline Progress Update bicycletherapeutics.com ↗
BT8009 pharmacokinetic profile consistent with preclinical predictions based on early clinical data; first clinical site outside the United States expected to open for recruitment this quarter |
| 2019-03-29 | BicycleTx Limited | Results Bicycle Therapeutics to Present Preclinical Data on EphA2 and Nectin-4 Bicycle Toxin Conjugate Programs, as well as a CD137 Immune Oncology Program, at the American Association for Cancer Research Annual Meeting bicycletherapeutics.com ↗
Preclinical data from both our BT5528 and BT8009 programs show target-dependent anti-tumor activity across a range of EphA2-expressing and Nectin-4-expressing cancer models, respectively, and we’re proud that AACR has chosen to highlight our work. |
All press releases naming this drug 24 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zelenectide pevedotin | “Zelenectide pevedotin (BT8009) is a Bicycle Drug Conjugate” PMID 41197088 ↗ Nov 2025 |
| Known as | BT8009 | “Zelenectide pevedotin (BT8009)” NCT06840483 ↗ |
| Known as | Zelenectida pevedotina | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314903 ↗ |
| Known as | Zelenectide pavedotin | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314903 ↗ |
| Known as | Zelenectide pevedotine | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314903 ↗ |
| Modality | Peptide | “highly selective Nectin-4-targeting Bicycle peptide” PMID 41197088 ↗ Nov 2025 |
| Modality | Protein / enzyme biologic | — CHEMBL5314903 ↗ |
| Route | Intravenous | “received zelenectide pevedotin intravenously at 2.5, 5.0, or 7.5 mg/m2” PMID 41197088 ↗ Nov 2025 |