A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
ConditionHematologic Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Body weight >= 40 kg
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
JNJ-95804306
DrugJNJ-95804306 will be administered orally.
AML SoC
DrugAML SoC will be administered subcutaneously/intravenously.
CLL/SLL SoC
DrugCLL/SLL SoC will be administered orally/ intravenously.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS)Experimental treatment 2 interventions
Group B: Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) or NHL monotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
DLT is defined as any toxicity that requires discontinuation of treatment; any toxicity resulting in dose reduction of study treatment, any toxicity resulting in a participant receiving less than (\<) 2/3 of their intended dose; any grade 5 toxicity; non-hematologic toxicity (grade 3 or 4); and unacceptable hematologic toxicity.
Time frame
Up to 28 days after first full dose of study drug2
Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 6.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
Time frame
Up to 6 years 5 monthsSecondary outcomes
1
For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
DLT is defined as any toxicity that requires discontinuation of treatment; any toxicity resulting in dose reduction of study treatment, any toxicity resulting in a participant receiving less than (\<) 2/3 of their intended dose; any grade 5 toxicity; non-hematologic toxicity (grade 3 or 4); and unacceptable hematologic toxicity.
Time frame
Up to first 28 days after first dose of study drug2
Serum Concentrations of JNJ-95804306
Serum samples will be analyzed to determine concentrations of JNJ-95804306.
Time frame
Up to approximately 6 years 5 months3
Area Under the Curve From Time of Administration until End of Dosing Interval (AUC[t]) of JNJ-95804306
AUC\[t\] is defined as the area under the plasma concentration time curve during a dosing interval at steady-state.
Time frame
Up to approximately 6 years 5 months4
Maximum Plasma Concentration (Cmax) of JNJ-95804306
Cmax is defined as the maximum serum concentration of JNJ-95804306.
Time frame
Up to approximately 6 years 5 monthsSponsors and contacts
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Source ClinicalTrials.gov