Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07450859
Eligibility Criteria:
Inclusion Criteria
* At least 18 years of age at the time of signature of the informed consent form
* Measurable disease as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 12 weeks
* Histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC)
* Participants must have failed only 1 prior line of therapy with evidence of radiographic progression. Neoadjuvant or adjuvant systemic therapy may count as the first line if the participant progressed less than 6 months from the end of systemic therapy. Prior treatment with KRAS inhibitors is permitted
* Participants must have sufficient tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers
* Adequate organ function (hematologic, renal, and hepatic)
* Negative pregnancy test for participants of childbearing potential (POCBP)
* Must be willing and able to comply with the protocol and study procedures
Exclusion Criteria
* Chemotherapy or radiotherapy within 14 days prior to the first dose of study treatment
* Experimental treatments within 28 days or 5 half-lives, whichever is longer, of first dose of BT5528 study treatment
* Prior treatment with taxane therapy (e.g., paclitaxel) for pancreatic cancer or prior treatment with any MMAE-containing agent
* Known microsatellite instability-high (MSI-H) status and are eligible for immune checkpoint inhibitor therapy
* Prior toxicities must have resolved to Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0
* Untreated central nervous system (CNS) metastases
Note: Additional protocol defined Inclusion/Exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07450859
Study Brief:
Protocol Section:
NCT07450859