Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BT8009, Zelenectide pevedotin (BT8009)
Zelenectide pevedotin · 5 trials · 12 indications
Incidence, severity, seriousness, relationship, and type of serious adverse events (SAEs), treatment-related adverse events (TRAEs), adverse events of clinical interest (AECIs), and treatment modifications as a result of any of these
Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
The time from randomization to date of first documentation of disease progression or death.
The time from randomization to date of first documentation of disease progression or death.
Safety reported as incidence of treatment-emergent adverse events using CTCAE v5.0 criteria.
Number of patients who experience dose limiting toxicities BT8009 when given as a monotherapy or in combination with pembrolizumab.
Proportion of participants with confirmed complete response or partial response to BT8009 as a monotherapy or in combination with pembrolizumab according to RECIST 1.1 criteria.
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.
Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.
Number of participants with advanced solid tumor malignancies associated with Nectin-4 expression receiving an alternative dose regimen of BT8009 as a monotherapy who experience treatment-emergent adverse events using CTCAE v5.0 criteria.
| Arm | Type | Description |
|---|---|---|
| Zelenectide pevedotin | EXPERIMENTAL | - |
| BT7480 | EXPERIMENTAL | - |
| Nuzefatide pevedotin | EXPERIMENTAL | - |
| Cohort A (non-squamous NSCLC) | EXPERIMENTAL | - |
| Cohort B (squamous NSCLC) | EXPERIMENTAL | - |
| Cohort A (HR+/HER2-negative breast cancer) | EXPERIMENTAL | - |
| Cohort B (TNBC) | EXPERIMENTAL | - |
| Cohort 1: Zelenectide pevedotin Arm 1 | EXPERIMENTAL | Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab. |
| Cohort 1: Zelenectide pevedotin Arm 2 | EXPERIMENTAL | Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab. |
| Cohort 1: Arm 3 | ACTIVE_COMPARATOR | Participants will receive Platinum-based combination chemotherapy +/- avelumab maintenance |
| Cohort 2: Zelenectide pevedotin Arm 1 | EXPERIMENTAL | Participants will receive zelenectide pevedotin. |
| Cohort 2: Zelenectide pevedotin Arm 2 | EXPERIMENTAL | Participants will receive zelenectide pevedotin. |
| Part A-1 -BT8009 Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive escalating doses of BT8009. |
| Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation | EXPERIMENTAL | Participants will receive BT8009 and a standard dose of pembrolizumab. |
| Cohort B-1 - BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Cohort B-2- BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Cohort B-3- BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. . |
| Cohort B-4- BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Cohort B-5- BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Cohort B-6- BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009 and standard dose of pembrolizumab. |
| Part C - Renal Insufficiency BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Part D - BT8009 Monotherapy Supplementary PK | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Part B-8 - BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Part B-9 - BT8009 Monotherapy Dose Expansion | EXPERIMENTAL | Participants will receive a selected dose of BT8009. |
| Name | Type | Description |
|---|---|---|
| Zelenectide pevedotin | DRUG | Participants will continue on the same treatment regimen they were receiving in their parent study. |
| BT7480 | DRUG | Participants will continue on the same treatment regimen they were receiving in their parent study. |
| Nuzefatide pevedotin | DRUG | Participants will continue on the same treatment regimen they were receiving in their parent study. |
| Zelenectide pevedotin (BT8009) | DRUG | Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle. |
| Pembrolizumab | DRUG | Participants will receive Pembrolizumab on Day 1 of every 21-day cycle. Pembrolizumab infusion will be started 30 minutes following the completion of the zelenectide pevedotin infusion. |
| Gemcitabine + cisplatin Or carboplatin | DRUG | Participants will receive Gemcitabine on Days 1 and 8 of every 21-day cycle plus cisplatin Or carboplatin on Day 1 of every 21-day cycle. |
| Avelumab | DRUG | After 4-6 cycles of Gemcitabine + Cisplatin or Carboplatin participants will receive maintenance Avelumab, if clinically indicated, on Days 1 and 15 each 28-day cycle. |
| BT8009 | DRUG | 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. |
Inclusion Criteria: * Participants must be receiving a Bicycle investigational product in another Bicycle-sponsored clinical study and will benefit from continued study treatment as assessed by the Investigator. The participant must be tolerating the treatment and the disease being treated has not ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Zelenectide pevedotin is an investigational therapy being studied in adults with advanced solid tumors, including metastatic urothelial cancer, breast cancer, and NECTIN4-amplified non-small cell lung cancer. It is also available through a continued access protocol for participants receiving a Bicycle investigational product. It is not approved for any indication.
Zelenectide pevedotin targets Nectin-4, a protein expressed on certain tumor cells. It is an antibody-drug conjugate (ADC) that uses a peptide-based targeting component, reflecting Bicycle Therapeutics' bicyclic peptide, or -tide, platform to deliver a cytotoxic payload to Nectin-4-expressing cancer cells.
Zelenectide pevedotin is being developed by Bicycle Therapeutics plc, which trades on the Nasdaq under the ticker BCYC. The company is advancing the asset across multiple solid tumor indications as part of its oncology pipeline.
Zelenectide pevedotin is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority for commercial use.
Zelenectide pevedotin is being evaluated in several Phase 2 trials, including NCT06225596 (Duravelo-2) in metastatic urothelial cancer, NCT06840483 in advanced breast cancer, NCT06933329 in NECTIN4-amplified non-small cell lung cancer, and NCT07681674, a continued access protocol for advanced solid tumors.
Yes, Zelenectide pevedotin is also known as BT8009. BT8009 was the earlier code name for the same investigational compound, and both names refer to the Nectin-4-targeting antibody-drug conjugate being developed by Bicycle Therapeutics.