A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

Официальное название

A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

Обзор

This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC.

Вмешательства

• Препарат BMS-986506
  Specified dose on specified days

Первичные конечные точки

• Number of Participants With Adverse Events (AEs) [Срок оценки: Up to approximately 2 years from first dose of BMS-986506]
• Number of Participants With Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 2 years from first dose of BMS-986506]
• Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria [Срок оценки: Up to approximately Day 28]
• Number of Participants With AEs Leading to Discontinuation [Срок оценки: Up to approximately 2 years from first dose of BMS-986506]
• Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0 [Срок оценки: Up to approximately 2 years from first dose of BMS-986506]

Вторичные конечные точки (7)

• Maximum Observed Plasma Concentration (Cmax) of BMS-986506 [Срок оценки: Up to approximately Day 85]
• Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506 [Срок оценки: Up to approximately Day 112]
• Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506 [Срок оценки: Up to approximately Day 112]
• Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [Срок оценки: Up to approximately 3 years from first dose of BMS-986506]
• Disease Control Rate (DCR) as Assessed by RECIST v1.1 [Срок оценки: Up to approximately 3 years from first dose of BMS-986506]
• Duration of Response (DOR) as Assessed by RECIST v1.1 [Срок оценки: Up to approximately 3 years from first dose of BMS-986506]
• Time to Response (TTR) as Assessed by RECIST v1.1 [Срок оценки: Up to approximately 3 years from first dose of BMS-986506]

Критерии участия

Критерии включения

• Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.
• For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.
• For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other).
• Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Критерии исключения

• Participants with Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.
• For Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.
• Participants who have hypoxia as defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen.
• Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.
• 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

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Dana-Farber Cancer Institute — Boston
• Memorial Sloan Kettering Cancer Center — New York
• Fox Chase Cancer Center — Philadelphia
• SCRI Oncology Partners — Nashville
• START San Antonio — San Antonio

Испания · 2 центра

• Hospital Universitario Reina Sofia — Córdoba
• Hospital Universitari Vall d'Hebron — Barcelona

Канада · 1 центр

• Arthur J.E. Child Comprehensive Cancer Centre — Calgary

Франция · 1 центр

• Gustave Roussy — Villejuif

Идентификаторы

NCT: NCT07195682 · CA242-0001 · 2025-522543-18 · U1111-1323-5879

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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