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

Официальное название

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

Обзор

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.

Подробное описание

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) who have progressed on or after one prior line of systemic therapy. 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).

Вмешательства

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

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 3 years]

Вторичные конечные точки (12)

• Duration of Response (DoR) per RECIST v1.1 [Срок оценки: Up to approximately 3 years]
• Overall Survival (OS) [Срок оценки: Up to approximately 3 years]
• Disease Control Rate (DCR) per RECIST v1.1 [Срок оценки: Up to approximately 3 years]
• Clinical Benefit Rate (CBR) per RECIST v1.1 [Срок оценки: Up to approximately 3 years]
• Progression-Free Survival (PFS) per RECIST v1.1 [Срок оценки: Up to approximately 3 years]
• Time to Progression (TTP) per RECIST v1.1 [Срок оценки: Up to approximately 3 years]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to approximately 3 years]
• Incidence of treatment emergent serious adverse events (TESAEs) [Срок оценки: Up to approximately 3 years]
• Incidence of laboratory abnormalities [Срок оценки: Up to approximately 3 years]
• Incidence of ECG abnormalities [Срок оценки: Up to approximately 3 years]
• Incidence of abnormal vital signs [Срок оценки: Up to approximately 3 years]
• Incidence of treatment modification due to adverse events [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Siteman Cancer Center (Washington University School of Medicine) — St Louis
• Memorial Sloan Kettering Cancer Center - Main Campus — New York
• Thomas Jefferson University, Sidney Kimmel Comprensive Cancer Center, Clinical Trials Offi — Philadelphia

Идентификаторы

NCT: NCT07450859 · BT5528-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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