A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Официальное название

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Обзор

The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248. The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.

Вмешательства

• Препарат Tarlatamab
  Administered as an IV infusion.
• Препарат AB248
  Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.

Первичные конечные точки

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to 2.5 years]
• Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs) [Срок оценки: Up to 35 days]

Вторичные конечные точки (12)

• Maximum Serum Concentration (Cmax) of Tarlatamab [Срок оценки: Up to approximately 21 weeks]
• Minimum Serum Concentration (Cmin) of Tarlatamab [Срок оценки: Up to approximately 21 weeks]
• Area Under the Concentration-time Curve (AUC) of Tarlatamab [Срок оценки: Up to approximately 21 weeks]
• Half-life (t1/2) of Tarlatamab [Срок оценки: Up to approximately 21 weeks]
• Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Срок оценки: Up to 2.5 years]
• Duration of Response (DOR) per RECIST 1.1 [Срок оценки: Up to 2.5 years]
• Time to Response (TTR) per RECIST 1.1 [Срок оценки: Up to 2.5 years]
• Disease Control (DC) per RECIST 1.1 [Срок оценки: Up to 2.5 years]
• Progression-free Survival (PFS) per RECIST 1.1 [Срок оценки: Up to 2.5 years]
• Time to Progression (TTP) per RECIST 1.1 [Срок оценки: Up to 2.5 years]
• Time to Subsequent Therapy [Срок оценки: Up to 2.5 years]
• Overall Survival (OS) [Срок оценки: Up to 2.5 years]

Критерии участия

Критерии включения

• Participant has provided informed consent before initiation of any study-specific activities/procedures.
• Participants ≥ 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 ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.
• Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
• Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
• Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy.

Критерии исключения

• Symptomatic central nervous system (CNS) metastases.
• Participants with brain metastases may be eligible if criteria defined in the protocol are met.
• Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
• Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
• Baseline (at rest) requirement of supplemental oxygen.

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 · 13 центров

• Banner MD Anderson Cancer Center — Gilbert
• University of Southern California, Norris Comprehensive Cancer Center — Los Angeles
• Moffitt Cancer Center — Tampa
• Emory University — Atlanta
• Norton Cancer Institute - Downtown — Louisville
• Dana-Farber Cancer Institute — Boston
• Siteman Cancer Center — St Louis
• Memorial Sloan Kettering Cancer Center — New York
• … и ещё 5 центров

South Korea · 3 центра

• Chungbuk National University Hospital — Cheongju Chungbuk
• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do
• Severance Hospital Yonsei University Health System — Seoul

Turkey (Türkiye) · 3 центра

• Adana Sehir Egitim ve Arastirma Hastanesi — Adana
• Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara
• Ankara Bilkent Sehir Hastanesi — Ankara

Идентификаторы

NCT: NCT07037758 · 20240200

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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