Study on Nuzefatide Pevedotin for Patients with Advanced Pancreatic Cancer

Sponsor: BicycleTx Limited

Sponsor score: 0

ClinicalTrials ID:NCT07450859

Provider View

This clinical trial is testing a new drug, nuzefatide pevedotin, in adults with advanced pancreatic cancer that has spread and worsened after one previous treatment. The study aims to see how well the drug works, its side effects, and how the body processes it.

Patient Parameters

Program Overview

This Phase 2 study is for adults with a type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (PDAC) that has spread and gotten worse after one previous treatment. The drug being tested, nuzefatide pevedotin, is designed to target a specific protein called EphA2, which is often found on cancer cells. The main goals of the study are to see how effective the drug is against the cancer, what side effects it might cause, and how the body handles the drug. All participants will receive nuzefatide, and both they and their doctors will know what treatment is being given. The trial will be conducted at multiple medical centers.

Description

This study is a Phase 2 trial, meaning it is focused on evaluating how well the drug works and its safety in a larger group of people. It is open-label, so both the participants and the doctors know what treatment is being given. The study involves a single group of participants, all of whom will receive the drug nuzefatide pevedotin. This drug is a new type of treatment that targets a protein called EphA2, which is often present on cancer cells, and delivers a powerful anti-cancer agent directly to them. The study will take place at several different medical centers, allowing for a diverse group of participants.

Eligibility Criteria

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

Locations

FACILITYZIPCITYSTATE
Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Office19107PhiladelphiaPennsylvania

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