Phase 1 Study of PF-08046033 in Advanced Solid Tumors

Официальное название

A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors

Обзор

This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer. The study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma. The study has two parts: In the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing. Once a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer. Participants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.

Вмешательства

• Препарат PF-08046033
  Powder for solution for infusion.

Первичные конечные точки

• Type, incidence and severity of participants with adverse events (AEs) [Срок оценки: From the first day through 30-37 days after the last study treatment, up to approximately 1 year]
• Type, incidence, and severity of participants with laboratory abnormalities [Срок оценки: From the first day through 30-37 days after the last study treatment, up to approximately 1 year]
• Number of participants with dose modifications [Срок оценки: From the first day through 30-37 days after the last study treatment, up to approximately 1 year]
• Incidence of dose-limiting toxicities (DLTs) [Срок оценки: From the first day through 30-37 days after the last study treatment, up to approximately 1 year]
• Recommended dose and schedule of PF-08046033 for expansion (RDE) [Срок оценки: Up to 1 year]

Вторичные конечные точки (11)

• Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator [Срок оценки: Up to 3 years]
• Duration of response (DOR) using RECIST v1.1 as assessed by investigator [Срок оценки: Up to 3 years]
• Progression-free survival (PFS) using RECIST v1.1 as assessed by investigator [Срок оценки: Up to 3 years]
• Overall survival (OS) using RECIST v1.1 as assessed by investigator [Срок оценки: Up to 3 years]
• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of PF-08046033 [Срок оценки: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, , Up to approximately 1 year]
• PK: Area under the concentration-time curve (AUC) of PF-08046033 [Срок оценки: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year]
• PK: Time to Maximum concentration (Tmax) of PF-08046033 [Срок оценки: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year]
• PK: Trough concentration (Ctrough) of PF-08046033 [Срок оценки: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year]
• PK: Terminal Elimination half-life (t1/2) of PF-08046033 [Срок оценки: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year]
• Incidence of antidrug antibodies (ADAs) [Срок оценки: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year]
• Percent change of immune cells and PD-L1 expression based on immunohistochemistry [Срок оценки: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year]

Критерии участия

Критерии включения

• Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma.
• Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2).
• Participants must have measurable disease.
• Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.

Критерии исключения

• Participants with known clinically active central nervous system (CNS) metastases.
• Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.
• Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.
• Untreated clinically significant thromboembolic disease.
• Previous exposure to GPNMB-targeted therapy.
• Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Presbyterian/St Lukes Medical Center — Denver
• Sarah Cannon Research Institute at HealthONE — Denver
• Sarah Cannon Research Institute- Pharmacy — Nashville
• SCRI Oncology Partners — Nashville

Пуэрто-Рико · 2 центра

• Hospital Oncologico Dr. Isaac Gonzalez-Martinez — Rio Piedras
• Pan American Center for Oncology Trials, LLC — Rio Piedras

Идентификаторы

NCT: NCT07519655 · C5921001 · GPS [GPNMB-AurS]

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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