Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:09 PM
Study NCT ID:
NCT07450859
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Sponsor:
BicycleTx Limited
Organization:
Study Overview
Official Title:
A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: