Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Официальное название

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Обзор

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Вмешательства

• Препарат Tarlatamab
  Administered by SC injection.

Первичные конечные точки

• Number of Participants with Dose-limiting toxicities (DLTs) [Срок оценки: Up to day 21]
• Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 24 months]
• Number of Participants with Changes in Vital Signs [Срок оценки: Up to approximately 24 months]
• Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (12)

• Maximum Serum Concentration (Cmax) of Tarlatamab [Срок оценки: Up to approximately 12 months]
• Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab [Срок оценки: Up to approximately 12 months]
• Time to Cmax (Tmax) of Tarlatamab [Срок оценки: Up to approximately 12 months]
• Area Under the Concentration-time Curve (AUC) of Tarlatamab [Срок оценки: Up to approximately 12 months]
• Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Срок оценки: Up to approximately 24 months]
• Duration of Response (DOR) per RECIST 1.1 [Срок оценки: Up to approximately 24 months]
• Time to Response (TTR) per RECIST 1.1 [Срок оценки: Up to approximately 24 months]
• Progression-free Survival (PFS) per RECIST 1.1 [Срок оценки: Up to approximately 24 months]
• Time to Progression per RECIST 1.1 [Срок оценки: Up to approximately 24 months]
• Time to Subsequent Therapy [Срок оценки: Up to approximately 24 months]
• Overall Survival (OS) [Срок оценки: Up to approximately 24 months]
• Number of Participants with Anti-tarlatamab Antibody Formation [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
• Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.

Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
• Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
• Participants must be able to have SC injections administered in the abdomen.
• Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.

Критерии исключения

• Participants that have received prior DLL3 targeted therapy.
• Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
• Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
• Participants with leptomeningeal disease.
• Participants with baseline oxygen requirement.

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

Фундаментальное исследование

Центры проведения

США · 6 центров

• University of Southern California, Norris Comprehensive Cancer Center — Los Angeles
• University of Illinois Chicago — Chicago
• Trinity Health Saint Joseph Mercy Ann Arbor — Ann Arbor
• Avera Cancer Institute — Sioux Falls
• University of Texas MD Anderson Cancer Center — Houston
• Swedish Cancer Institute — Seattle

Испания · 4 центра

• Hospital Regional Universitario de Malaga — Málaga
• Hospital Universitari Vall d Hebron — Barcelona
• Hospital Universitari i Politecnic La Fe — Valencia
• Hospital Universitario 12 de Octubre — Madrid

Австралия · 3 центра

• Chris OBrien Lifehouse — Camperdown
• Calvary Mater Newcastle Hospital — Waratah
• The Alfred Hospital — Melbourne

Бельгия · 3 центра

• Universitair Ziekenhuis Gent — Ghent
• Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven
• Centre Hospitalier Universitaire de Liege - Sart Tilman — Liège

Польша · 3 центра

• Uniwersyteckie Centrum Kliniczne — Gdansk
• Instytut Centrum Zdrowia Matki Polki — Lodz
• Wojewodzki Szpital im Sw Ojca Pio w Przemyslu — Przemyśl

Швейцария · 3 центра

• Kantonsspital Graubuenden — Chur
• Freiburg Spital — Fribourg
• Kantonsspital Winterthur — Winterthur

Turkey (Türkiye) · 3 центра

• Adana Sehir Egitim ve Arastirma Hastanesi — Adana
• Ankara Bilkent Sehir Hastanesi — Ankara
• Koc Universitesi Hastanesi — Istanbul

Китай · 2 центра

• Jilin Cancer Hospital — Changchun
• Shanghai Pulmonary Hospital — Шанхай

Германия · 2 центра

• Universitaetsklinikum Regensburg — Regensburg
• Universitaetsklinikum Wuerzburg — Würzburg

Япония · 2 центра

• Okayama University Hospital — Okayama
• Wakayama Medical University Hospital — Wakayama

Идентификаторы

NCT: NCT06598306 · 20230298

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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