A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

Официальное название

A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

Обзор

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Вмешательства

• Препарат BMS-986340
  Specified dose on specified days
• Препарат BMS-936558-01
  Specified dose on specified days
• Препарат Docetaxel
  Specified dose on specified days
• Препарат Pumitamig
  Specified dose on specified days

Первичные конечные точки

• Incidence of adverse events (AEs) [Срок оценки: Up to 120 weeks]
• Incidence of serious adverse events (SAEs) [Срок оценки: Up to 120 weeks]
• Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [Срок оценки: Up to either 21 or 28 days]
• Incidence of AEs leading to discontinuation [Срок оценки: Up to 120 weeks]
• Number of deaths [Срок оценки: Up to 120 weeks]

Вторичные конечные точки (12)

• Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU)) [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered in combination with docetaxel: Cmax [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered in combination with docetaxel: Tmax [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU) [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau) [Срок оценки: Up to 120 weeks]
• PK parameters of BMS-986340 administered in combination with docetaxel: Ctau [Срок оценки: Up to 120 weeks]

Критерии участия

Критерии включения

• Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
• Eastern Cooperative Oncology Group Performance Status of 0 or 1.
• Radiographically documented progressive disease on or after the most recent therapy.
• Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
• Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.

Критерии исключения

• Women who are pregnant or breastfeeding.
• Primary central nervous system (CNS) malignancy.
• Untreated CNS metastases.
• Leptomeningeal metastases.
• Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
• Active, known, or suspected autoimmune disease.
• Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
• Prior organ or tissue allograft.
• Uncontrolled or significant cardiovascular disease.
• Major surgery within 4 weeks of study drug administration.
• History of or with active interstitial lung disease or pulmonary fibrosis.
• 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

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 11 центров

• Community Cancer Institute — Clovis
• USC/Norris Comprehensive Cancer Center — Los Angeles
• Hoag Memorial Hospital Presbyterian — Newport Beach
• University of Iowa — Iowa City
• John Theurer Cancer Center — Hackensack
• Local Institution - 0006 — New York
• Local Institution - 0002 — New York
• Providence Cancer Center Oncology and Hematology Care- Eastside — Portland
• … и ещё 3 центра

Испания · 7 центров

• Hospital Universitario Virgen de la Victoria — Málaga
• Institut Catalan d Oncologia (ICO) - Badalona — Badalona
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD — Madrid
• Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid — Madrid
• Clinica Universidad de Navarra-oNCOLOGY — Pamplona

Австралия · 6 центров

• Blacktown Hospital — Blacktown
• Liverpool Hospital — Liverpool
• Princess Alexandra Hospital — Brisbane
• Cabrini Hospital - Malvern — Malvern
• St Vincent's Hospital — Melbourne
• One Clinical Research — Nedlands

Канада · 6 центров

• Cross Cancer Institute — Edmonton
• Local Institution - 0030 — Vancouver
• Hamilton Health Sciences-Juravinski Cancer Centre — Hamilton
• Local Institution - 0009 — Toronto
• Centre Hospitalier de luniversite de Montreal — Montreal
• Local Institution - 0016 — Ottawa

Италия · 6 центров

• Humanitas — Rozzano
• Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia — Candiolo
• Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 — Milan
• Istituto Nazionale Tumori IRCCS Fondazione Pascale — Naples
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma
• ospedale le scotte-U.O.C. Immunoterapia Oncologica — Siena

Германия · 5 центров

• Local Institution - 0044 — Ulm
• Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Tr — Dresden
• Universitaetsklinikum Essen — Essen
• Universitatsklinikum Frankfurt — Frankfurt
• Universitaetsklinikum Wuerzburg — Würzburg

Израиль · 5 центров

• Rabin Medical Center — Petah Tikva
• Local Institution - 0035 — Ramat Gan
• Sheba Medical Center — Ramat Gan
• Rambam Health Care Campus — Haifa
• Sourasky Medical Center — Tel Aviv

Япония · 1 центр

• National Cancer Center Hospital East — Kashiwa

Идентификаторы

NCT: NCT04895709 · CA052-002 · 2023-503651-10 · U1111-1265-4508

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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