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RecruitingInterventionalPhase 1

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

NCT ID: NCT07572006Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

Summary

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).

Arms & interventions

  • DrugJNJ-95804306

    JNJ-95804306 will be administered orally.

  • DrugAML SoC

    AML SoC will be administered subcutaneously/intravenously.

  • DrugCLL/SLL SoC

    CLL/SLL SoC will be administered orally/ intravenously.

Outcome measures

Primary

  • Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

    A DLT is defined as any toxicity that requires discontinuation of treatment; any Grade 5 toxicity; Non-hematologic Toxicity (Grade 3 or 4); and unacceptable hematologic toxicity.

    Time frame: Up to 21 days after first full dose of study drug

  • 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 months

Secondary

  • For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: Up to first 28 days after first dose of study drug

  • Serum Concentrations of JNJ-95804306

    Time frame: 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

    Time frame: Up to approximately 6 years 5 months

  • Maximum Plasma Concentration (Cmax) of JNJ-95804306

    Time frame: Up to approximately 6 years 5 months

  • Minimum Plasma Concentration (Cmin) of JNJ-95804306

    Time frame: Up to approximately 6 years 5 months

  • Complete Response (CR) in Participants with Acute Myeloid Leukemia (AML)

    Time frame: Up to 6 years 5 months

  • Overall Response (OR) in Participants with Myelodysplastic Syndrome (MDS)

    Time frame: Up to 6 years 5 months

  • Complete Response (CR) in Participants with MDS

    Time frame: Up to 6 years 5 months

  • Overall Response (OR) in Participants with Chronic Lymphocytic Leukemia (CLL)

    Time frame: Up to 6 years 5 months

  • Complete Response in Participants with CLL

    Time frame: Up to 6 years 5 months

  • Overall Response in Participants with Small Lymphocytic Lymphoma (SLL)

    Time frame: Up to 6 years 5 months

  • Complete Response in Participants with SLL

    Time frame: Up to 6 years 5 months

  • Duration of Response (DoR)

    Time frame: Up to 6 years 5 months

  • Time to Response (TTR)

    Time frame: Up to 6 years 5 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion criteria: 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: * 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. a. Participants must have received at least 2 prior lines of therapy; b. 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 * Body weight \>= 40 kg * ECOG performance status of 0 to 2 * Have clinically measurable disease * 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 judgment. a. Participants must have received at least 2 prior lines of therapy Exclusion criteria: For Arm A: * 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 * 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 2016 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

Study locations (3)

Indiana Blood & Marrow Transplantation

Indianapolis, Indiana, 46237

Recruiting

Start Midwest

Grand Rapids, Michigan, 49546

Recruiting

Rutgers Cancer Institute of New Jersey

Piscataway, New Jersey, 08854

Recruiting