Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

Официальное название

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer

Обзор

The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.

Вмешательства

• Препарат ZL-1310
  ZL-1310 will be administered as an IV infusion.
• Препарат Tarlatamab
  Tarlatamab will be administered as an IV infusion.
• Препарат Durvalumab
  Durvalumab will be administered as an IV infusion.

Первичные конечные точки

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to 3.5 years]
• Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) [Срок оценки: Up to Day 21]

Вторичные конечные точки (9)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [Срок оценки: Up to 3.5 years]
• Duration of Response (DOR) per RECIST v1.1 [Срок оценки: Up to 3.5 years]
• Time to Response (TTR) per RECIST v1.1 [Срок оценки: Up to 3.5 years]
• Disease Control Rate (DCR) per RECIST v1.1 [Срок оценки: Up to 3.5 years]
• Progression-free Survival (PFS) per RECIST v1.1 [Срок оценки: Up to 3.5 years]
• Time to Progression (TTP) per RECIST v1.1 [Срок оценки: Up to 3.5 years]
• Time to Subsequent Therapy [Срок оценки: Up to 3.5 years]
• Overall survival (OS) [Срок оценки: Up to 3.5 years]
• Serum Tarlatamab Concentrations [Срок оценки: Up to Week 36]

Критерии участия

Критерии включения

• Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
• Participants with Histologically or cytologically confirmed SCLC:
• For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
• For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.
• For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy.

Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated.
• Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).

Критерии исключения

• Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.
• History of interstitial lung disease (ILD)/pneumonitis.
• Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.
• Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.
• Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
• Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment.
• Enrollment in any tarlatamab clinical trial.

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 · 7 центров

• City of Hope Cancer Center Phoenix — Goodyear
• Moffitt Cancer Center — Tampa
• City of Hope Chicago — Zion
• Health Partners Cancer Center at Regions Hospital — Saint Paul
• New York University Cancer Institute — New York
• Baptist Cancer Center — Memphis
• Next Virginia — Fairfax

Испания · 5 центров

• Hospital Clinico Universitario Virgen de la Victoria — Málaga
• Hospital Universitari Vall d Hebron — Barcelona
• Hospital Clinico Universitario de Valencia — Valencia
• Hospital Universitario Ramon y Cajal — Madrid
• Hospital Universitario 12 de Octubre — Madrid

Turkey (Türkiye) · 3 центра

• Adana Sehir Egitim ve Arastirma Hastanesi — Adana
• Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara
• Izmir Ekonomi Universitesi Medical Point Hastanesi — Izmir

Бельгия · 2 центра

• Universitair Ziekenhuis Gent — Ghent
• Ziekenhuis aan de Stroom Augustinus — Wilrijk

Франция · 2 центра

• Hopital de la Timone — Marseille
• Gustave Roussy — Villejuif

Германия · 2 центра

• Universitaetsklinikum Dresden — Dresden
• Universitaetsklinikum Wuerzburg — Würzburg

Польша · 2 центра

• Uniwersyteckie Centrum Kliniczne — Gdansk
• Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy — Gliwice

Швейцария · 1 центр

• Kantonsspital Sankt Gallen — Sankt Gallen

Идентификаторы

NCT: NCT07531095 · 20250114 · 2025-522888-15-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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