Pancreatic Ductal Adenocarcinoma study: Nuzefatide pevedotin
Official title A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
ClinicalTrials.gov ID: NCT07450859
What this study is testing
What is nuzefatide pevedotin (BT5528)?
nuzefatide pevedotin (BT5528) is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for pancreatic ductal adenocarcinoma (pdac).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new drug called nuzefatide pevedotin works against the tumor. It also looks at how safe the drug is and how the body handles it.
- Who it's for
- You may be able to join if you are an adult with advanced pancreatic cancer that has spread.
- What's involved
- You would receive the drug nuzefatide pevedotin. You and your doctor will know you are getting this specific treatment.
- Time commitment
- The study involves visits to a medical center to receive the drug and check on your health.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
You likely can't join 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 Note: Additional protocol defined Inclusion/Exclusion criteria apply
See the full eligibility 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.
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States; St Louis, Missouri, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.