A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

Официальное название

A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors

Обзор

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.

Вмешательства

• Препарат BMS-986507
  Specified dose on specified days
• Препарат Osimertinib
  Specified dose on specified days
• Препарат Pembrolizumab
  Specified dose on specified days
• Препарат Nivolumab
  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 3 years]
• Number of participants with serious adverse events (SAEs) [Срок оценки: Up to 3 years]
• Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera [Срок оценки: Up to 3 years]
• Number of participants with AEs leading to discontinuation [Срок оценки: Up to 3 years]
• Number of participants with AEs leading to death [Срок оценки: Up to 3 years]
• Number of DLTs that occur during the DLT evaluation period [Срок оценки: Up to 3 weeks]

Вторичные конечные точки (5)

• Maximum observed serum concentration (Cmax) [Срок оценки: Up to 3 years]
• Time of maximum observed concentration (Tmax) [Срок оценки: Up to 3 years]
• Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Срок оценки: Up to 3 years]
• Area under the serum concentration-time curve within a dosing interval (AUC(TAU)) [Срок оценки: Up to 3 years]
• Objective response rate (ORR) [Срок оценки: Up to 2 year]

Критерии участия

Критерии включения

• Participants must have at least one measurable lesion per response evaluation criteria in solid tumors.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Participants must have a life expectancy of at least 3 months at the time of the first dose.
• Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed
• Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC.
• Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC.
• Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO/CAP criteria, based on the most recently analyzed biopsy or another pathology specimen.
• Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent.

Критерии исключения

• Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.
• Participants with known mutations in EGFR will be excluded (Group A,B and E).
• Participants must not have a history of serious recurrent infections.
• Participants must not have a history of severe heart disease.
• 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

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 13 центров

• University of Alabama at Birmingham — Birmingham
• University of Miami Hospital and Clinics, Sylvester Cancer Center — Miami
• Local Institution - 0065 — Iowa City
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack
• Cleveland Clinic — Cleveland
• Local Institution - 0102 — Columbus
• Providence Portland Medical Center — Portland
• Providence St. Vincent Medical Center — Portland
• … и ещё 5 центров

Испания · 13 центров

• CHUS - Hospital Clinico Universitario — Santiago de Compostela
• Hospital Universitari Vall d'Hebron — Barcelona
• Institut Català d'Oncologia - L'Hospitalet — Hospitalet
• Local Institution - 0059 — Barcelona
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda
• Local Institution - 0118 — Valencia
• Hospital Universitario Fundación Jiménez Díaz — Madrid
• … и ещё 5 центров

Франция · 9 центров

• Local Institution - 0077 — Nice
• Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux
• Centre Leon Berard — Lyon
• Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone — Marseille
• Local Institution - 0076 — Caen
• Hôpital Arnaud de Villeneuve - CHU Montpellier — Montpellier
• Gustave Roussy — Villejuif
• Institut Curie — Paris
• … и ещё 1 центр

Канада · 6 центров

• Cross Cancer Institute — Edmonton
• Local Institution - 0064 — Newmarket
• Local Institution - 0023 — Ottawa
• The Ottawa Hospital - General Campus — Ottawa
• Centre Hospitalier de l'Université de Montréal — Montreal
• Jewish General Hospital — Montreal

Чили · 5 центров

• Local Institution - 0105 — Valdivia
• Local Institution - 0048 — Santiago
• Local Institution - 0049 — Santiago
• Local Institution - 0047 — Santiago
• Local Institution - 0107 — Viña del Mar

Италия · 5 центров

• Cro-Irccs — Aviano
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
• Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia — Candiolo
• Azienda Ospedaliera Universitaria Careggi — Florence
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma

Австралия · 4 центра

• Liverpool Hospital — Liverpool
• Princess Alexandra Hospital — Woolloongabba
• Peter MacCallum Cancer Centre — Melbourne
• Local Institution - 0101 — Subiaco

Великобритания · 4 центра

• Royal Free Hospital — London
• Local Institution - 0021 — Glasgow
• University Hospitals Birmingham NHS Foundation Trust — Birmingham
• Local Institution - 0001 — Newcastle upon Tyne

Нидерланды · 2 центра

• Leids Universitair Medisch Centrum — Leiden
• Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) — Amsterdam

Идентификаторы

NCT: NCT06618287 · CA244-0001 · 2024-514947-27 · U1111-1308-2752

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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