Recruiting
Phase 2

BT5528

Sponsor:

BicycleTx Limited

Code:

NCT07450859

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

nuzefatide pevedotin (BT5528)

Study Details

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 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.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Study ID

NCT07450859

Start date

Mar 5, 2026

Status verified date

Apr, 2026

Completion date

May, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

39 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: nuzefatide pevedotin (BT5528) Monotherapy

Interventions

nuzefatide pevedotin (BT5528)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

BicycleTx Limited

6179458155clinicalstudies@bicycletx.com

Locations

Mayo Clinic Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Clinical Trials Referral Office

855-776-0015

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015

Siteman Cancer Center (Washington University School of Medicine)

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Kian-Huat Lim

kian-huat.lim@wustl.edu

Memorial Sloan Kettering Cancer Center - Main Campus

Recruiting

New York, New York, United States, 10065

Contacts

Kenneth Yu

646-888-4188

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

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

onctrialnow@jefferson.edu

More Information

Sponsor

BicycleTx Limited

Last update posted

Aug 13, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BicycleTx Limited on 2026-08-13.