A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

Официальное название

A Phase 1, First-in-human, Dose Escalation Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

Обзор

The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose \[RP2D\]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone and/or when administered in addition to standard of care (SoC) therapy at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system). For US sites: The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose \[RP2D\]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system).

Вмешательства

• Препарат JNJ-95804306
  JNJ-95804306 will be administered orally.
• Препарат AML SoC
  AML SoC will be administered subcutaneously/intravenously.
• Препарат CLL/SLL SoC
  CLL/SLL SoC will be administered orally/ intravenously.

Первичные конечные точки

• Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) [Срок оценки: Up to 28 days after first full dose of study drug]
• Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: Up to 6 years 5 months]

Вторичные конечные точки (12)

• For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) [Срок оценки: Up to first 28 days after first dose of study drug]
• Serum Concentrations of JNJ-95804306 [Срок оценки: Up to approximately 6 years 5 months]
• Area Under the Curve From Time of Administration until End of Dosing Interval (AUC[t]) of JNJ-95804306 [Срок оценки: Up to approximately 6 years 5 months]
• Maximum Plasma Concentration (Cmax) of JNJ-95804306 [Срок оценки: Up to approximately 6 years 5 months]
• Minimum Plasma Concentration (Cmin) of JNJ-95804306 [Срок оценки: Up to approximately 6 years 5 months]
• Complete Response (CR) in Participants with Acute Myeloid Leukemia (AML) [Срок оценки: Up to 6 years 5 months]
• Overall Response (OR) in Participants with Myelodysplastic Syndrome (MDS) [Срок оценки: Up to 6 years 5 months]
• Complete Response (CR) in Participants with MDS [Срок оценки: Up to 6 years 5 months]
• Overall Response (OR) in Participants with Chronic Lymphocytic Leukemia (CLL) [Срок оценки: Up to 6 years 5 months]
• Complete Response in Participants with CLL [Срок оценки: Up to 6 years 5 months]
• Overall Response in Participants with Non-Hodgkin Lymphoma (NHL) Subtypes Including Small Lymphocytic Lymphoma (SLL) [Срок оценки: Up to 6 years 5 months]
• Complete Response in Participants With NHL Subtypes Including SLL [Срок оценки: Up to 6 years 5 months]

Критерии участия

Критерии включения

For Arm A:

• Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or very high-risk per the molecular international prognostic scoring system (IPSSM). All participants must have relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options
• Body weight greater than or equal to (>=) 40 kilograms (kg)
• Eastern cooperative oncology group (ECOG) performance status of 0 to 2

For Arm B:

• All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgement. Have a diagnosis of either: Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) meeting 2018 International workshop on chronic lymphocytic leukemia (iwCLL) National cancer institute (NCI) working group guidelines (Hallek 2018) that meet the following criteria:

a. Participants must have received at least 2 prior lines of therapy; b. Have clinically measurable disease

• Body weight >= 40 kg
• ECOG performance status of 0 to 2
• Must sign an Informed consent form (ICF)
• For US sites: Have a diagnosis of CLL/SLL that meets iwCLL, NCI Working Group Guidelines which is relapsed or refractory and requires treatment with no other approved therapies available that would be more appropriate in the investigator's judgement. a. Participants must have received at least 2 prior lines of therapy

Критерии исключения

For Arm A:

• Has acute promyelocytic leukemia according to world health organization (WHO) 2022 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team (SET) decision
• Need for supplemental oxygen use to maintain adequate oxygenation
• Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
• For US sites: Has acute promyelocytic leukemia according to WHO 2022 criteria or known active CNS involvement of AML/MDS

For Arm B:

• Need for supplemental oxygen use to maintain adequate oxygenation
• Have evidence of uncontrolled systemic viral, bacterial, or fungal infection requiring initiation of parenteral treatment as medical intervention
• Developed Richter's transformation or prolymphocytic leukemia
• Known active CNS or leptomeningeal involvement of CLL/SLL/Non-Hodgkin lymphoma (NHL)

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

• Indiana Blood & Marrow Transplantation — Indianapolis
• Start Midwest — Grand Rapids
• Rutgers Cancer Institute of New Jersey — Piscataway
• NYU Langone Health — New York
• Sarah Cannon Cancer Institute — Nashville

Австралия · 1 центр

• Peter MacCallum Cancer Centre — Melbourne

Бельгия · 1 центр

• UZ Antwerpen — Edegem

Великобритания · 1 центр

• The Christie Nhs Foundation Trust — Manchester

Идентификаторы

NCT: NCT07572006 · 95804306EDI1001 · 95804306EDI1001 · 2026-525234-39 · 2026-525234-39-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗