Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Zelenectide pevedotin (BT8009)
Zelenectide pevedotin · 4 trials · 4 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.
| 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. |
| 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. |
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 ...
Zelenectide pevedotin is an investigational small molecule being studied for the treatment of metastatic urothelial cancer, non-small cell lung cancer, advanced solid tumors, and breast cancer. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Zelenectide pevedotin is a peptide-based small molecule, classified under the -tide (peptide) target class. It is designed to target NECTIN4, as indicated by its clinical trial in NECTIN4 amplified non-small cell lung cancer. The drug is being developed by Bicycle Therapeutics.
Zelenectide pevedotin is developed by Bicycle Therapeutics plc, a biopharmaceutical company listed on the stock exchange under the ticker BCYC. The company is conducting multiple Phase 2 clinical trials to evaluate the drug's safety and efficacy in various oncology indications.
Zelenectide pevedotin is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing trials are evaluating its use in metastatic urothelial cancer, breast cancer, non-small cell lung cancer, and advanced solid tumors.
Zelenectide pevedotin is being studied in several Phase 2 trials, including NCT06225596 for metastatic urothelial cancer, NCT06840483 for advanced breast cancer, NCT06933329 for NECTIN4 amplified non-small cell lung cancer, and NCT07681674 for advanced solid tumors. These trials are actively recruiting or ongoing.
Yes, Zelenectide pevedotin is also known as BT8009. The drug is referred to by both names in clinical trial documentation and research literature. It is being developed by Bicycle Therapeutics for multiple oncology indications.