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 antibody-drug conjugate being studied in oncology for advanced solid tumors historically known for high EphA2 expression and for pancreatic ductal adenocarcinoma (PDAC). It is not approved for any indication and remains in clinical development.
Nuzefatide pevedotin targets EphA2, a receptor tyrosine kinase that is overexpressed in several solid tumor types. The agent is an antibody-drug conjugate built on Bicycle Therapeutics' bicyclic peptide, or -tide, platform, which delivers a cytotoxic payload to EphA2-expressing tumor cells.
Nuzefatide pevedotin is being developed by Bicycle Therapeutics plc, which trades on Nasdaq under the ticker BCYC. The company is the sponsor of the clinical program evaluating the agent in EphA2-associated solid tumors and in pancreatic ductal adenocarcinoma.
Nuzefatide pevedotin is in Phase 1 development, with a Phase 2 study also recruiting in metastatic pancreatic ductal adenocarcinoma. It is an investigational agent and has not been approved by the FDA or any other regulatory authority for commercial use.
Nuzefatide pevedotin is being evaluated in NCT04180371, a Phase 1 study in advanced solid tumors associated with EphA2 expression that is active but no longer recruiting, and in NCT07450859, a recruiting Phase 2 study in metastatic pancreatic ductal adenocarcinoma conducted in the United States and South Korea.
Yes. Nuzefatide pevedotin is also known as BT5528, and the two names refer to the same investigational antibody-drug conjugate from Bicycle Therapeutics. Publications, trial records, and company materials use both designations interchangeably for this EphA2-targeted agent.