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

Official record

Identifier

NCT07450859

Recruiting locations

countries

United StatesSouth Korea

Interventions studied

nuzefatide pevedotin (BT5528)

Lead sponsor

BicycleTx Limited

Target enrolment

39 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Mar 5, 2026

Last updated on the registry

Sep 18, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria

* At least 18 years of age at the time of signature of the informed consent form (or at least 19 years where locally defined as minimum age of consent).
* 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 whose disease has progressed on or after only 1 prior line of therapy or on or after second line therapy with a KRAS inhibitor, 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 in the first-line setting is permitted if there was no intervening treatment prior to enrollment.
* 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 and agree to participate in the study by providing written informed consent.

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 nuzefatide 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

Indexed under

Pancreatic Cancer