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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2NCT07450859

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

A Phase 2 study testing nuzefatide pevedotin (BT5528) in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by BicycleTx Limited at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma (PDAC)
What is being tested?
nuzefatide pevedotin (BT5528)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
8 sitesin 2 countries
Study dates
5 Mar 2026to May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

BicycleTx Limited contact

6179458155

clinicalstudies@bicycletx.com

8 sites in 2 countries

United States6 sites, 6 recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Clinical Trials Referral Office, 855-776-0015

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, 10065

    Kenneth Yu, 646-888-4188

    Recruiting

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

    Philadelphia, Pennsylvania, 19107

    onctrialnow@jefferson.edu

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Clinical Trials Referral Office, 855-776-0015

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015

    Recruiting

  • Siteman Cancer Center (Washington University School of Medicine)

    St Louis, Missouri, 63108

    Kian-Huat Lim, kian-huat.lim@wustl.edu

    Recruiting

Other trials in United States

South Korea2 sites, 2 recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Hyun Jung Cho, hyunjungcho@snu.ac.kr

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Jieun Oh, jieun55.oh@sbri.co.kr

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the detailed 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).

Being tested
nuzefatide pevedotin (BT5528)
Keywords
Pancreatic Cancer, BT5528, EphA2, Bicycle Drug Conjugate, MMAE, Metastatic, Pancreatic Ductal Adenocarcinoma, PDAC, Nuzefatide Pevedotin
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nuzefatide pevedotin (BT5528)Drug

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

Study groups in NCT07450859
Study groupRoleWhat they receive
nuzefatide pevedotin (BT5528) MonotherapyExperimentalNot described
Receives: Drug: nuzefatide pevedotin (BT5528)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to approximately 3 years

Secondary outcomes (13)

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

    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

    Measured: Up to approximately 3 years

  2. Overall Survival (OS)

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

    Measured: Up to approximately 3 years

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

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

    Measured: Up to approximately 3 years

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

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

    Measured: Up to approximately 3 years

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

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

    Measured: Up to approximately 3 years

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

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

    Measured: Up to approximately 3 years

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

    Proportion of participants experiencing an adverse event on treatment

    Measured: Up to approximately 3 years

  8. Incidence of treatment-related adverse events (TRAEs)

    Proportion of participants experiencing an adverse event determined by the Investigator to be related to study treatment

    Measured: Up to approximately 3 years

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

    Proportion of participants experiencing serious adverse events on treatment

    Measured: Up to approximately 3 years

  10. Incidence of laboratory abnormalities

    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

    Measured: Up to approximately 3 years

  11. Incidence of ECG abnormalities

    Proportion of participants that experience abnormal ECG parameters on treatment

    Measured: Up to approximately 3 years

  12. Incidence of abnormal vital signs

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

    Measured: Up to approximately 3 years

  13. Incidence of treatment modification due to adverse events

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

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start5 Mar 2026
  3. Primary completionMar 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07450859
Sponsor's protocol ID
BT5528-201
Status last verified
Apr 2026
First submitted
26 Feb 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nuzefatide pevedotin (BT5528) in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by BicycleTx Limited at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BicycleTx Limited (6179458155, clinicalstudies@bicycletx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07450859.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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