A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

Официальное название

A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

Обзор

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Вмешательства

• Препарат PF-08046054
  Given into the vein (IV; intravenously)
• Препарат pembrolizumab
  200 mg once every 3 weeks given into the vein (IV; intravenously)

Первичные конечные точки

• Number of participants with adverse events (AEs) [Срок оценки: Through approximately 90 days after last study treatment; up to 3 years]
• Number of participants with laboratory abnormalities [Срок оценки: Through approximately 90 days after last study treatment; up to 3 years]
• Number of participants with dose-limiting toxicities (DLTs) [Срок оценки: Through the first cycle of study treatment; approximately 1 month]
• Number of participants with DLTs by dose level [Срок оценки: Through the first cycle of study treatment; approximately 1 month]

Вторичные конечные точки (8)

• Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment [Срок оценки: Up to approximately 3 years]
• Duration of objective response (DOR) per RECIST v1.1 by investigator assessment [Срок оценки: Up to approximately 3 years]
• Progression-free survival (PFS) per RECIST v1.1 by investigator assessment [Срок оценки: Up to approximately 3 years]
• Overall survival (OS) [Срок оценки: Up to approximately 3 years]
• Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC) [Срок оценки: Through 30-37 days after last study treatment; up to approximately 3 years]
• PK parameter - Maximum concentration (Cmax) [Срок оценки: Through 30-37 days after last study treatment; up to approximately 3 years]
• PK parameter - Trough concentration (Ctrough) [Срок оценки: Through 30-37 days after last study treatment; up to approximately 3 years]
• Incidence of anti-drug antibodies (ADAs) [Срок оценки: Through 30-37 days after last study treatment; up to approximately 3 years]

Критерии участия

Критерии включения

• Parts A and B:

• Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types

• Non-small cell lung cancer (NSCLC)
• Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)
• Esophageal squamous cell carcinoma (SCC)
• Triple negative breast cancer (TNBC)
• Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
• Participants must have PD-L1 expression based on historical testing
• Part C:

• Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types

• HNSCC

• Participants with HNSCC must have histologically or cytologically-confirmed HNSCC
• NSCLC

• Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.
• Esophageal SCC
• Pancreatic cancer
• Hepatocellular carcinoma
• TNBC
• Gastric cancer
• Endometrial cancer
• Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or <1 by CPS or TPS based on historical testing
• Part D and Part E:

• Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
• Participants must have PD-L1 expression based on historical testing
• Participants with NSCLC; PD-L1 expression ≥ 1% by TPS
• Participants with HNSCC; PD--L1 expression ≥1 by CPS
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Measurable disease per RECIST v1.1 at baseline

Критерии исключения

• History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
• Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:

• Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
• Have no new or enlarging brain metastases
• And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment
• Lepto-meningeal disease
• Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
• Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
• Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

There are additional inclusion criteria. The study center will determine if criteria for participations are met.

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 · 25 центров

• University of Alabama at Birmingham — Birmingham
• University of Alabama at Birmingham, IDS Pharmacy — Birmingham
• University of Alabama at Birmingham — Birmingham
• University of Alabama at Birmingham — Birmingham
• Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine
• UC Irvine Health - Chao Family Comprehensive Cancer Center — Orange
• University of California Davis Comprehensive Cancer Center — Sacramento
• University of California, Davis Medical Center — Sacramento
• … и ещё 17 центров

Великобритания · 7 центров

• Diagnostic Centre — London
• The Harley Street Clinic (THSC) — London
• Pharmacy: Royal Marsden Hospital — Sutton
• Royal Marsden Hospital — Sutton
• The Royal Marsden NHS Foundation Trust — London
• Sarah Cannon Research Institute — London
• Radiology — London

Франция · 6 центров

• Hôpital Saint André - CHU Bordeaux — Bordeaux
• Clinique Ambroise Pare — Neuilly-sur-Seine
• Institut Curie — Paris
• lnstitut Curie Pharmacy — Paris
• Gustave Roussy Institute - Service pharmacie — Villejuif
• Gustave Roussy Institute — Villejuif

Испания · 6 центров

• CETIR Viladomat — Barcelona
• Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet) — Barcelona
• Hospital Quiron Salud Barcelona — Barcelona
• NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona — Barcelona
• Hospital Universitari Vall d'Hebron — Barcelona
• START Madrid - CIOCC - Hospital Universitario HM Sanchinarro — Madrid

Китай · 4 центра

• Beijing Friendship Hospital, Capital Medical University — Пекин
• Beijing Cancer Hospital — Пекин
• Shanghai East Hospital — Шанхай
• Beijing Friendship hospital, Capital Medical University — Пекин

Италия · 4 центра

• Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologi — Milan
• Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi — Verona
• Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi — Verona
• UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna — Bologna

Канада · 3 центра

• University Health Network — Toronto
• University Health Network, Princess Margaret Hospital — Toronto
• McGill University Health Centre — Montreal

Германия · 3 центра

• Charite Comprehensive Cancer Center — Berlin
• Charite Universitatsmedizin Berlin — Berlin
• Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum — Berlin

Япония · 2 центра

• National Cancer Center Hospital East — Kashiwa
• Shizuoka Cancer Center — Nagaizumi-cho

Бельгия · 1 центр

• Institut Jules Bordet — Anderlecht

Нидерланды · 1 центр

• The Netherlands Cancer Institute — Amsterdam

Идентификаторы

NCT: NCT05208762 · SGNPDL1V-001 · C5851001 · 2023-506604-18-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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