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

NCT07450859 | Recruiting Phase 2 FDA Drug

• 1 other identifier: BT5528-201
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

Pancreatic Cancer; BT5528; EphA2; Bicycle Drug Conjugate; MMAE; Metastatic; Pancreatic Ductal Adenocarcinoma; PDAC; Nuzefatide Pevedotin

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator

  Up to approximately 3 years

Secondary Outcomes (12)

• Duration of Response (DoR) per RECIST v1.1

  Up to approximately 3 years

• Overall Survival (OS)

  Up to approximately 3 years

• Disease Control Rate (DCR) per RECIST v1.1

  Up to approximately 3 years

• Clinical Benefit Rate (CBR) per RECIST v1.1

  Up to approximately 3 years

• Progression-Free Survival (PFS) per RECIST v1.1

  Up to approximately 3 years

Study Arms (1)

nuzefatide pevedotin (BT5528) Monotherapy

EXPERIMENTAL

Drug: nuzefatide pevedotin (BT5528)

Interventions

nuzefatide pevedotin (BT5528) DRUG

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

nuzefatide pevedotin (BT5528) Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BicycleTx Limited: lead

Study Sites (1)

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

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

BicycleTx Limited

CONTACT

617-945-8155; clinicalstudies@bicycletx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 5, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)