Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BT5528, nuzefatide pevedotin (BT5528)
Nuzefatide pevedotin · 2 trials · 8 indications
Percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator
Safety reported as incidence of treatment-emergent adverse events
Maximum Tolerated Dose (MTD)
Objective Response Rate (ORR)
Duration of Response (DOR)
Clinical benefit rate
Time to Progression (TTP)
Progression free survival (PFS)
Progression free survival (PFS)
Overall survival (OS)
| Arm | Type | Description |
|---|---|---|
| nuzefatide pevedotin (BT5528) Monotherapy | EXPERIMENTAL | - |
| Phase I - Dose escalation (BT5528) | EXPERIMENTAL | Cohorts of participants will receive increasing doses of BT5528. It is expected that up to 72 participants will participate in this dose escalation arm. |
| Phase I - Dose escalation combination (BT5528 & nivolumab) | EXPERIMENTAL | Cohorts of participants will receive increasing doses of BT5528 and a standard dose of nivolumab. It is expected that up to 24 participants will participate in this dose-escalation combination arm. |
| Phase II - Dose expansion 1 (BT5528) | EXPERIMENTAL | A cohort of participants will receive the selected dose of BT5528 as a monotherapy. It is expected that up to 164 patients have solid tumors (Cohort 1: urothelial cancers, Cohort 2: ovarian cancer, Cohort 3: non-small cell lung cancer, Cohort 4: head and neck cancer, Cohort 5: triple-negative breast cancer, and Cohort 6: gastric/upper gastrointestinal cancer) historically known for high expression of EphA2 will participate in this dose-expansion arm, Cohort 7: urothelial MMAE exposed, Cohort 8: head and neck squamous cell carcinoma |
| Name | Type | Description |
|---|---|---|
| nuzefatide pevedotin (BT5528) | DRUG | Participants will receive nuzefatide pevedotin (BT5528) via intravenous (IV) infusion every 2 weeks (Q2W) |
| BT5528 | DRUG | Participants will receive a 60-minute intravenous infusion of BT5528 once a week (Days 1, 8, 15, and 22) or every other week (Days 1 and 15) on a 4-week cycle at the selected dose. |
| Nivolumab | DRUG | Participants will receive nivolumab at 480mg intravenous infusion every 4 weeks. |
Inclusion Criteria * At least 18 years of age at the time of signature of the informed consent form (or at least 19 years where locally defined as minimum age of consent). * Measurable disease as defined by RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Lif...
Nuzefatide pevedotin is an investigational small molecule being studied for the treatment of metastatic Pancreatic Ductal Adenocarcinoma (PDAC). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Nuzefatide pevedotin targets EphA2, a receptor tyrosine kinase. It is a peptide-based small molecule designed to bind to EphA2, which is overexpressed in certain tumors, including pancreatic ductal adenocarcinoma.
Nuzefatide pevedotin is being developed by Bicycle Therapeutics plc, a biopharmaceutical company. The company's stock is traded under the ticker symbol BCYC on the NASDAQ.
Nuzefatide pevedotin is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is recruiting patients with metastatic pancreatic ductal adenocarcinoma.
Nuzefatide pevedotin is being evaluated in a Phase 2 clinical trial with the identifier NCT07450859. This trial is recruiting patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) in the United States, with an estimated enrollment of 39 participants.
Yes, nuzefatide pevedotin is also known as BT5528. Both names refer to the same investigational drug being developed by Bicycle Therapeutics for the treatment of pancreatic ductal adenocarcinoma.