A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer

Официальное название

A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer

Обзор

The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Pumitamig in participants with Relapsed/Refractory Small Cell Lung Cancer

Вмешательства

• Препарат BMS-986525
  Specified dose on specified days
• Препарат Pumitamig
  Specified dose on specified days

Первичные конечные точки

• Number of participants with adverse events (AEs) [Срок оценки: Up to approximately 2 years]
• Number of participants with serious adverse events (SAEs) [Срок оценки: Up to approximately 2 years]
• Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria [Срок оценки: Up to 21 days]
• Number of participants with AEs leading to discontinuation [Срок оценки: Up to approximately 2 years]
• Number of participants with AEs leading to death [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (4)

• Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment [Срок оценки: Up to approximately 3 years]
• Maximum observed concentration within a dosing interval (Cmax) [Срок оценки: Up to approximately 2 years]
• Time of maximum observed plasma concentration within a dosing interval (Tmax) [Срок оценки: Up to approximately 2 years]
• Area under the concentration-time curve within a dosing interval (AUC(TAU)) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Participants must have histologically or cytologically documented relapsed/refractory small cell lung cancer (R/R-SCLC).
• Participants must have received at least 1 platinum-based chemotherapy regimen as per locally approved drug labels and institutional guidelines.
• In countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with anti-PD-(L)1 therapy, it is required that participants have progressed on, are ineligible for or not have access to an anti-PD- (L)1 therapy.

Критерии исключения

• Participants must not have any untreated CNS metastases.
• Participants must not have an active, known or suspected autoimmune disease.
• Participants must not have had a prior organ or tissue allograft.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Karmanos Cancer Institute — Detroit
• Local Institution - 0026 — Buffalo
• Duke Cancer Institute — Durham
• University Hospitals Cleveland Medical Center — Cleveland
• SCRI Oncology Partners — Nashville

Япония · 2 центра

• Local Institution - 0020 — Hirakata
• Local Institution - 0018 — Chuo-ku

Румыния · 2 центра

• Oncohelp Medical Center — Timișoara
• Local Institution - 0003 — Craiova

Китай · 1 центр

• Local Institution - 0028 — Shanghai Shi

Италия · 1 центр

• Istituto Clinico Humanitas — Rozzano

Испания · 1 центр

• Local Institution - 0009 — Madrid

Идентификаторы

NCT: NCT07325136 · CA258-0001 · 2025-524090-16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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