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NCT Number: NCT07450859

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

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.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC) Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Siteman Cancer Center (Washington University School of Medicine), St Louis, Missouri, United States

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About this study

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) who have progressed on or after one prior line of systemic therapy. 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

nuzefatide pevedotin (BT5528)

Drug

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

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to approximately 3 years

    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

Secondary outcomes

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

    Time frame: Up to approximately 3 years

    The time from the first documentation of a tumor response (that is subsequently confirmed) to the first documentation of disease progression or death per RECIST v1.1

  2. Overall Survival (OS)

    Time frame: Up to approximately 3 years

    The length of time from the first day of study treatment (Day 1) to day of death

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

    Time frame: Up to approximately 3 years

    Percentage of participants who achieve a confirmed CR, PR, or stable disease (SD) per RECIST v1.1

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

    Time frame: Up to approximately 3 years

    Defined as the proportion of participants with CR, PR, or SD ≥12 weeks per RECIST v1.1

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

    Time frame: Up to approximately 3 years

    The time from the first day of study treatment to the first documentation of disease progression or death per RECIST v1.1

  6. Time to Progression (TTP) per RECIST v1.1

    Time frame: Up to approximately 3 years

    TTP defined as the time from first dose of nuzefatide until date of first documentation of disease progression per RECIST v1.1

  7. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to approximately 3 years

    Proportion of participants experiencing an adverse event on treatment

  8. Incidence of treatment emergent serious adverse events (TESAEs)

    Time frame: Up to approximately 3 years

    Proportion of participants experiencing serious adverse events on treatment

  9. Incidence of laboratory abnormalities

    Time frame: Up to approximately 3 years

    Proportion of participants that experience abnormal laboratory values (blood chemistry (including liver function tests and creatinine clearance), hematology (including hemoglobin, neutrophil and platelet absolute counts)) on treatment

  10. Incidence of ECG abnormalities

    Time frame: Up to approximately 3 years

    Proportion of participants that experience abnormal ECG parameters on treatment

  11. Incidence of abnormal vital signs

    Time frame: Up to approximately 3 years

    Proportion of participants that have changes in vital signs such as blood pressure, heart rate, oxygen saturation, respiratory rate, and body temperature on treatment

  12. Incidence of treatment modification due to adverse events

    Time frame: Up to approximately 3 years

    Proportion of participants that require any treatment modification due to adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

BicycleTx Limited

CONTACT

[email protected]

6179458155

Sponsors and collaborators

Lead sponsor

BicycleTx Limited

Industry

Registry information

Official study title

A Phase 2 Study of BT5528 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 5, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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