Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07450859
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.
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:
NCT07450859
Study Brief:
Protocol Section:
NCT07450859