A phase 1, first-in-human, dose escalation study of JNJ-95804306 for relapsed or refractory hematological malignancies
Hematologic neoplasms, blood cancer
Arm A: R/R Acute Myeloid Leukaemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS) Participants with relapsed/refractory (R/R) AML/HR-MDS will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to standard of care (SoC) therapy in AML (Arm A2) to determine the putative recommended phase 2 dose (RP2D) in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to SoC therapy in AML (Arm A2) at the determined RP2D regimen(s). JNJ-95804306 will be administered orally. AML SoC will be administered subcutaneously/intravenously Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) Participants with R/R CLL/SLL will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in CLL/SLL (Arm B2 or B3) to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in CLL/SLL (Arm B2 or B3) at the determined RP2D regimen(s). JNJ-95804306 will be administered orally. CLL/SLL SoC will be administered orally/intravenously.
For Arm A: 1. 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 2. Body weight greater than or equal to (>=) 40 kilograms (kg) 3. Eastern cooperative oncology group (ECOG) performance status of 0 to 2 For Arm B: 1. Have a diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) that meets international workshop on chronic lymphocytic leukemia (iwCLL), National cancer institute (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 judgment. 1.1. Participants must have received at least 2 prior lines of therapy 1.2. Participants who have received at least one prior line of therapy but are not eligible or do not have access to standard second line therapies, will be allowed to enroll 2. Body weight >= 40 kg 3. ECOG performance status of 0 to 2 4. Have clinically measurable disease
For Arm A: 1. Has acute promyelocytic leukemia according to world health organization (WHO) 2016 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team (SET) decision 2. Need for supplemental oxygen use to maintain adequate oxygenation 3. Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted For Arm B: 1. Need for supplemental oxygen use to maintain adequate oxygenation 2. Have evidence of uncontrolled systemic viral, bacterial, or fungal infection requiring initiation of parenteral treatment as medical intervention 3. Developed Richter's transformation or prolymphocytic leukemia 4. Known active CNS or leptomeningeal involvement of CLL/SLL