A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

Официальное название

A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.

Обзор

The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them. The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.

Вмешательства

• Препарат PF-08046876
  Intravenous administration

Первичные конечные точки

• Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation [Срок оценки: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)]
• Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy [Срок оценки: Baseline to end of DLT evaluation period]
• Part 1: Recommended Monotherapy Dose for Expansion [Срок оценки: Baseline to 30 days post last study drug administration]
• Part 2: Recommended Phase 2 Dose [Срок оценки: Baseline to 30 days post last study drug administration]

Вторичные конечные точки (10)

• Objective Response Rate (ORR) [Срок оценки: Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)]
• Duration of Response (DOR) [Срок оценки: From the date of the first objective response to the date of disease progression or death (approximately 2 years)]
• Progression Free Survival (PFS) [Срок оценки: From Baseline to date of first disease progression or death (approximately 2 Years)]
• Overall Survival (OS) [Срок оценки: From baseline to up to 3 years]
• Pharmacokinetics (PK): Maximum Observed Serum Concentration (Cmax) [Срок оценки: Baseline to approximately 30 days after last dose of study drug]
• PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) [Срок оценки: Baseline to approximately 30 days after last dose of study drug]
• PK: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast) [Срок оценки: Baseline to approximately 30 days after last dose of study drug]
• Incidence of Anti-Drug Antibody (ADA) [Срок оценки: Baseline to approximately 30 days after last dose of study drug]
• Incidence of Neutralizing Antibodies (NAb) [Срок оценки: Baseline to approximately 30 days after last dose of study drug]
• Percent change of immune cells within tumors based on multiplex immunofluorescence [Срок оценки: Baseline through 4-7 weeks after first dose of study drug]

Критерии участия

Критерии включения

• 18 years of age or older
• Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas
• Measurable disease
• ECOG Performance status 0-1
• Part 1: progression or relapse following standard treatments
• Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting
• Resolution of acute effects of prior anticancer therapy to baseline or Grade 1
• Consent to submit required pre-treatment tumor tissue as medically feasible

Критерии исключения

• Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )
• Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocol exclusion
• Pulmonary disease meeting protocol exclusion
• Other unacceptable abnormalities as defined by protocol

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 21 центр

• City of Hope National Medical Center — Duarte
• City of Hope at Irvine Lennar — Irvine
• Ronald Reagan UCLA Medical Center — Los Angeles
• UCLA Department of Medicine-Hematology/Oncology — Los Angeles
• Santa Monica UCLA Medical Center & Orthopaedic Hospital — Santa Monica
• UCLA Hematology/Oncology - Santa Monica — Santa Monica
• Smilow Cancer Hospital - Yale New Haven Health — New Haven
• Yale - New Haven Hospital - Yale Cancer Center — New Haven
• … и ещё 13 центров

Канада · 3 центра

• Princess Margaret Cancer Centre — Toronto
• Princess Margaret Cancer Centre — Toronto
• McGill University Health Centre — Montreal

Испания · 3 центра

• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario Fundación Jiménez Díaz — Madrid

Великобритания · 2 центра

• Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of London — London
• The Christie NHS Foundation Trust — Manchester

Пуэрто-Рико · 1 центр

• Pan American Center for Oncology Trials, LLC — Rio Piedras

Идентификаторы

NCT: NCT07090499 · C5951001 · 2025-521729-33-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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