Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Официальное название

A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Обзор

This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.

Вмешательства

• Препарат INCA036978
  INCA036978 will be administered at protocol defined dose.
• Препарат Standard disease-directed therapy
  A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

Первичные конечные точки

• Number of participants with Dose Limiting Toxicities (DLT)s in Part 1 [Срок оценки: Up to 28 days]
• Number of participants with Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 2 years]
• Number of participants with TEAEs leading to dose modification or discontinuation [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (12)

• Pharmacokinetics Parameter: Cmax of INCA036978 [Срок оценки: Up to approximately 2 years]
• Pharmacokinetics Parameter: Tmax of INCA036978 [Срок оценки: Up to approximately 2 years]
• Pharmacokinetics Parameter: Cmax,ss of INCA036978 [Срок оценки: Up to approximately 2 years]
• Pharmacokinetics Parameter: Cmin,ss of INCA036978 [Срок оценки: Up to approximately 2 years]
• Pharmacokinetics Parameter: AUC(0-t) of INCA036978 [Срок оценки: Up to approximately 2 years]
• Pharmacokinetics Parameter: AUC 0-∞ of INCA036978 [Срок оценки: Up to approximately 2 years]
• Pharmacokinetics Parameter: CL/F of INCA036978 [Срок оценки: Up to approximately 2 years]
• Pharmacokinetics Parameter: Vz/F of INCA036978 [Срок оценки: Up to approximately 2 years]
• Pharmacokinetics Parameter: t1/2 of INCA036978 [Срок оценки: Up to approximately 2 years]
• For participants with myelofibrosis (MF): Percentage of participants achieving spleen volume reduction as defined in the protocol [Срок оценки: Week 12 and Week 24]
• For participants with MF and anemia: Anemia Response as defined in the protocol [Срок оценки: Up to approximately 2 years]
• For participants with polycythemia vera (PV): Peripheral blood count remission as defined by the protocol. [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Life expectancy > 6 months.
• Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).
• Participants with MF, PV and ET as defined in the protocol.

Критерии исключения

• Presence of any hematological malignancy other than MF, PV, or ET.
• Malignancy within the last 3 years prior to enrollment.
• Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.
• Clinically significant or uncontrolled cardiac disease.
• Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.
• Laboratory values outside the Protocol-defined ranges.
• Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.
• Presence of chronic or current active infectious disease requiring systemic treatment.
• Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.
• Prior radiation therapy within 28 days before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may 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 · 23 центра

• University of Alabama At Birmingham — Birmingham
• City of Hope-Lennar Foundation Cancer Center — Irvine
• Usc Norris Comprehensive Cancer Center — Los Angeles
• UCLA Medical Hematology & Oncology — Los Angeles
• Yale Cancer Center — New Haven
• University of Miami — Miami
• Moffitt Cancer Center — Tampa
• Winship Cancer Institute of Emory University — Atlanta
• … и ещё 15 центров

Австралия · 5 центров

• Concord General Repatriation Hospital — Concord
• Royal North Shore Hospital — St Leonards
• Icon Cancer Centre — Auchenflower
• Epworth Health Care — East Melbourne
• Linear Clinical Research — Nedlands

Германия · 5 центров

• University Medical Center Rwth Aachen — Aachen
• Charite Universitaetsmedizin Berlin - Campus Charite Mitte — Berlin
• Universitatklinikum Freiburg — Freiburg im Breisgau
• Universitatsklinikum Halle (Saale) — Halle
• Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii — Mainz

Италия · 4 центра

• Aou Policlinico S. Orsola-Malpighi — Bologna
• Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico — Milan
• A. Gemelli University Hospital, Catholic University of the Sacred Heart — Roma
• Azienda Sanitaria Universitaria Friuli Centrale Asu Fc — Udine

Франция · 3 центра

• Institut Bergonie — Bordeaux
• Hospital Saint Louis — Paris
• Institut Gustave Roussy — Villejuif

Испания · 3 центра

• Hospital Universitari Germans Trias I Pujol — Badalona
• Hospital Universitario de Gran Canaria Dr. Negrin — Las Palmas de Gran Canaria
• Hospital Universitario 12 de Octubre — Madrid

Великобритания · 3 центра

• Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust — London
• Nottingham University Hospitals — Nottingham
• University of Oxford — Oxford

Бельгия · 2 центра

• Centre Hospitalier Universitaire (Chu) de Liege — Liège
• AZ DELTA — Roeselare

Канада · 2 центра

• Princess Margaret Cancer Center — Toronto
• McGill University Jewish General Hospital — Montreal

Япония · 2 центра

• National Cancer Center Hospital East — Kashiwa Chiba
• Ehime University Hospital — Toon, Ehime

South Korea · 2 центра

• Seoul National University Hospital — Jongno-gu, Seoul
• The Catholic University of Korea Seoul St. Mary'S Hospital — Seocho-gu, Seoul

Идентификаторы

NCT: NCT07441694 · INCA036978-101 · 2026-525217-31-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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