NCT07450859

A Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: BicycleTx Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study for BT5528 in adults with a specific type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (PDAC) that has spread and worsened after one previous treatment. The drug, BT5528, is designed to find a specific protein called EphA2. The main aims of the study are to see how well the drug works against the tumor (efficacy), what side effects it may have (safety), and how the body processes it (pharmacokinetics). All participants in this study will receive BT5528, and both they and their doctors will know what is being administered (single-arm, open-label). The trial will take place at several different medical centers.

Detailed description

This is a Phase 2, open-label, multicenter, single-arm study to evaluate the efficacy, safety, and pharmacokinetics (PK) of BT5528 in adult participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on or after one prior line of systemic therapy. BT5528 is a novel Bicycle® drug conjugate (BDC®) that targets EphA2, a protein often found on cancer cells, and delivers a potent anti-cancer agent (MMAE).

Conditions

• Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

Type	Name	Description
DRUG	BT5528	Participants will receive BT5528 via intravenous (IV) infusion every 2 weeks (Q2W)

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-03-01
• Completion: 2029-05-01
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study