A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBicycleTx Limited
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
nuzefatide pevedotin (BT5528)
DrugParticipants will receive nuzefatide pevedotin (BT5528) via intravenous (IV) infusion every 2 weeks (Q2W)
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: nuzefatide pevedotin (BT5528) MonotherapyExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Up to approximately 3 yearsSecondary outcomes
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
Time frame
Up to approximately 3 years2
Overall Survival (OS)
The length of time from the first day of study treatment (Day 1) to day of death
Time frame
Up to approximately 3 years3
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
Time frame
Up to approximately 3 years4
Clinical Benefit Rate (CBR) per RECIST v1.1
Defined as the proportion of participants with CR, PR, or SD ≥12 weeks per RECIST v1.1
Time frame
Up to approximately 3 yearsSponsors and contacts
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Source ClinicalTrials.gov