Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

Официальное название

AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Обзор

This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments. To join in the study, participants must: * Be 18 years or older * Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread The study will look at: * Whether PF-08634404 is safe to use with other cancer medicines. * What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease. * Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors. The study has different parts, each testing PF-08634404 with a different cancer medicine: * Part A will test PF-08634404 with a medicine called sigvotatug vedotin. * Part B of the study will look at how well the new medicine PF-08634404 works when used together with another medicine. Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.

Вмешательства

• Биопрепарат PF-08634404
  -Concentrate for solution for infusion
• Биопрепарат Sigvotatug Vedotin
  -Powder for concentrate for solution for infusion. Single use vial
• Биопрепарат Combination Agent 1
  -Powder for concentrate for solution for infusion. Single use vial.

Первичные конечные точки

• Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Through 90 days after the last study intervention; Up to approximately 5 years]
• Phase I: Number of participants with dose limiting toxicity (DLT) [Срок оценки: Through 90 days after the last study intervention; Up to approximately 5 years]
• Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator [Срок оценки: Up to approximately 5 Years]

Вторичные конечные точки (7)

• Phase I: Confirmed ORR per RECIST v1.1 by investigator [Срок оценки: Up to approximately 5 Years]
• Disease Control Rate (DCR) per RECIST v1.1 by investigator [Срок оценки: Up to approximately 5 years]
• Duration of Response (DOR) per RECIST v1.1 by investigator [Срок оценки: Up to approximately 5 years]
• Progression Free Survival (PFS) per RECIST v1.1 by investigator [Срок оценки: Up to approximately 5 years]
• Number of Participants With Clinical Laboratory Abnormalities [Срок оценки: Through 90 days after the last study intervention; Up to approximately 5 years]
• Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents [Срок оценки: Up to 37 days after the last dose of treatment]
• Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents [Срок оценки: Up to 37 days after the last dose of treatment]

Критерии участия

Критерии включения

• Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
• PD-L1 status available
• Part B only: PD-L1 ≥ TPS 1%
• Measurable disease based on RECIST v1.1 per investigator.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Adequate organ function

Критерии исключения

• Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET
• History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
• Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
• Leptomeningeal disease
• Active autoimmune diseases requiring systemic treatment within the past 2 years
• Previous systemic anti-tumor therapy for locally advanced, unresectable, or metastatic NSCLC
• Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose 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 · 36 центров

• Highlands Oncology Group, PA — Fayetteville
• Highlands Oncology Group, PA — Rogers
• Highlands Oncology Group, PA — Springdale
• Providence Medical Foundation — Fullerton
• Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center — Fullerton
• Providence St. Jude Medical Center — Fullerton
• Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite) — Los Angeles
• Valkyrie Clinical Trials — Los Angeles
• … и ещё 28 центров

Испания · 16 центров

• HT Médica Jaen LAs Nieves — Jaén
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Jerez de la Frontera — Jerez de la Frontera
• Hospital Nuestra Señora del Rosario — Madrid
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario Virgen de la Victoria — Málaga
• Clínica Radiólogica Mario Gallegos — Málaga
• … и ещё 8 центров

Тайвань · 6 центров

• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
• Chang Gung Memorial Hospital at Kaohsiung — Kaohsiung City
• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei
• Mackay Memorial Hospital — Taipei
• Taipei Veterans General Hospital — Taipei

Китай · 4 центра

• Beijing Cancer hospital — Пекин
• Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology — Ухань
• Shanghai Chest Hospital — Шанхай
• Taizhou Hospital of Zhejiang Province — Taizhou

Франция · 3 центра

• Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux
• Centre Georges François Leclerc — Dijon
• Institut Paoli-Calmettes — Marseille

Италия · 3 центра

• Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) — Fano
• IRCCS Istituto Nazionale dei Tumori Regina Elena — Roma
• Ospedale Isola Tiberina - Gemelli Isola — Roma

Япония · 2 центра

• Kansai Medical University Hospital — Hirakata
• Shizuoka Cancer Center — Nagaizumi-cho

Пуэрто-Рико · 2 центра

• Pan American Center for Oncology Trials, LLC — Rio Piedras
• BRCR Global Puerto Rico - Hato Rey — San Juan

Германия · 1 центр

• Marien Hospital Düsseldorf — Düsseldorf

Идентификаторы

NCT: NCT07227298 · C6461020 · 2025-523526-40-00 · Symbiotic-Lung-20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗