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

BicycleTx

Status and phase

Enrolling

Phase 2

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Treatments

Drug: nuzefatide pevedotin (BT5528)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07450859

BT5528-201

Details and patient eligibility

About

This is a Phase 2 study for nuzefatide pevedotin (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 or two prior lines of treatment if treated with KRAS inhibitor.

The drug, nuzefatide pevedotin (nuzefatide), 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 nuzefatide, 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.

Full description

This is a Phase 2, open-label, multicenter, single-arm study to evaluate the efficacy, safety, and pharmacokinetics (PK) of nuzefatide in adult participants with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on or after one prior line of systemic therapy in the metastatic setting or on or after second line therapy with a KRAS inhibitor in the metastatic setting. Nuzefatide 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).

Enrollment

39 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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