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OncoMatch/Clinical Trials/NCT07450859

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

Is NCT07450859 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies BT5528 for pancreatic ductal adenocarcinoma (pdac).

Phase 2RecruitingBicycleTx LimitedNCT07450859Data as of May 2026

Treatment: BT5528This 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.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Biomarker criteria

Required: EPHA2 expression (testing required)

sufficient tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers

Excluded: MSI1 microsatellite instability-high (MSI-H)

Known microsatellite instability-high (MSI-H) status and are eligible for immune checkpoint inhibitor therapy

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: systemic therapy

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.

Cannot have received: taxane (paclitaxel)

Prior treatment with taxane therapy (e.g., paclitaxel) for pancreatic cancer

Cannot have received: antibody-drug conjugate

prior treatment with any MMAE-containing agent

Lab requirements

Blood counts

adequate organ function (hematologic, renal, and hepatic)

Kidney function

adequate organ function (hematologic, renal, and hepatic)

Liver function

adequate organ function (hematologic, renal, and hepatic)

Adequate organ function (hematologic, renal, and hepatic)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Office · Philadelphia, Pennsylvania

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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