Nuzefatide Pevedotin for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, nuzefatide pevedotin (BT5528), to evaluate its effectiveness for individuals with a type of pancreatic cancer that has progressed after one treatment. The drug targets a specific protein in the cancer cells. The study examines the drug's efficacy, potential side effects, and how the body processes it. Suitable participants have pancreatic ductal adenocarcinoma that has worsened after one treatment and can provide a tumor sample for testing. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in cancer therapy.
Will I have to stop taking my current medications?
The trial requires that you stop chemotherapy or radiotherapy at least 14 days before starting the study treatment. If you are on experimental treatments, you need to stop them 28 days or 5 half-lives before the first dose of the study drug, whichever is longer.
Is there any evidence suggesting that nuzefatide pevedotin is likely to be safe for humans?
Studies have shown that nuzefatide pevedotin, the drug tested in this trial, has generally been well-tolerated by patients. Research involving over 150 people suggests that the treatment is likely safe. Most patients experienced only minor side effects, and researchers deemed the treatment safe enough to continue testing.
Additionally, clinical data indicate that nuzefatide pevedotin has shown promising results in fighting tumors by targeting specific proteins in cancer cells. While researchers continue to study the drug, the safety results so far are encouraging for those considering joining this trial.12345Why do researchers think this study treatment might be promising for pancreatic cancer?
Nuzefatide Pevedotin (BT5528) is unique because it offers a novel approach to treating pancreatic cancer by targeting specific proteins on cancer cells. Unlike standard treatments like chemotherapy, which affects both healthy and cancerous cells, BT5528 is designed to precisely attack cancer cells with minimal impact on normal tissue. Researchers are excited about this treatment because it has the potential to reduce side effects and improve patient outcomes by delivering a more targeted and effective therapy.
What evidence suggests that nuzefatide pevedotin might be an effective treatment for pancreatic cancer?
Research has shown that nuzefatide pevedotin targets a protein called EphA2, often found in pancreatic cancer cells. In early studies, nuzefatide slowed tumor growth in models of pancreatic cancer made from patient samples. The data also indicate that nuzefatide was well-tolerated, causing no severe side effects. Encouragingly, it showed early signs of effectiveness against cancer when combined with another drug, nivolumab. These findings suggest that nuzefatide could be an effective treatment for pancreatic cancer. Participants in this trial will receive nuzefatide pevedotin as a monotherapy to further evaluate its effectiveness and safety.14567
Are You a Good Fit for This Trial?
This trial is for adults (18+) with metastatic pancreatic ductal adenocarcinoma that has gotten worse after one previous treatment. Participants need to have good organ function, a life expectancy of at least 12 weeks, and be able to follow study procedures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nuzefatide pevedotin (BT5528) to evaluate efficacy, safety, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nuzefatide Pevedotin (BT5528)
Trial Overview
The study tests nuzefatide pevedotin (BT5528), a drug targeting the EphA2 protein in cancer cells. All participants receive this drug, and both patients and doctors know what is given. The main goals are to see how well it works and its side effects.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
BicycleTx Limited
Lead Sponsor
Citations
1.
investors.bicycletherapeutics.com
investors.bicycletherapeutics.com/news-releases/news-release-details/bicycle-therapeutics-provides-update-nuzefatide-pevedotin-andBicycle Therapeutics Provides Update on Nuzefatide ...
Phase 1 combination data of 6.5mg/m2 Q2W nuzefatide pevedotin plus nivolumab demonstrate an encouraging preliminary efficacy profile with a ...
A Study of Nuzefatide Pevedotin (BT5528) in Patients With ...
This is a Phase 2 study for nuzefatide pevedotin (BT5528) in adults with a specific type of pancreatic cancer called metastatic pancreatic ductal adenocarcinoma ...
Bicycle Therapeutics Provides Update on Nuzefatide ...
Our strategy is to initially develop nuzefatide in pancreatic cancer where patients have limited available treatment options, and in parallel, ...
Nuzefatide Pevedotin for Pancreatic Cancer
This is a Phase 2 study for nuzefatide pevedotin (BT5528) in adults with a specific type of pancreatic cancer called metastatic pancreatic ...
Bicycle Therapeutics Reports Recent Business Progress ...
Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 demonstrates significant opportunities for nuzefatide ...
6.
aacrjournals.org
aacrjournals.org/cancerres/article/86/7_Supplement/4518/777762/Abstract-4518-Preclinical-assessment-of-BT5528Abstract 4518: Preclinical assessment of BT5528 anti-tumor ...
There is high unmet need for patients with EphA2-expressing tumors, including pancreatic cancer, which has one of the highest EphA2 expression ...
7.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-bt5528-in-patients-with-metastatic-pancreatic-ductal-adenocarcinoma-pdacA Study of Nuzefatide Pevedotin (BT5528) in Patients With ...
This is a Phase 2 study for nuzefatide pevedotin (BT5528) in adults with a specific type of pancreatic cancer called metastatic pancreatic
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