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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
BicycleTx Limited
Study ID
NCT07450859
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nuzefatide pevedotin (BT5528) — DRUG
    Participants will receive nuzefatide pevedotin (BT5528) via intravenous (IV) infusion every 2 weeks (Q2W)

Study Details

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. 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.

Key Dates

Start date
Mar 5, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: nuzefatide pevedotin (BT5528) Monotherapy

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials OfficePhiladelphiaPennsylvania19107-

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

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