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

Study Identifier:
95804306EDI1001
CT.gov Identifier:
NCT07572006
EudraCT Identifier:
202653000000
EU Trial (CTIS) Number:
2026-525234-39-00
Study Contact Information:
N/A
Will Be Recruiting

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Study 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).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
N/A
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Arm A: R/R Acute Myeloid Leukemia (AML)/ High-Risk Myelodysplastic Syndrome (HR MDS)
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Drug: 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). For US sites: Participants with R/R AML/HR-MDS will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). AML SoC will not be administered for US sites.
Drug: Drug: AML SoC
Drug: AML SoC will be administered subcutaneously/intravenously.
Drug: Drug: JNJ-95804306
Drug: JNJ-95804306 will be administered orally.
Drug: EXPERIMENTAL: Arm B: R/R Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)
Drug: 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). For US sites: Participants with R/R CLL/SLL will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). CLL/SLL SoC will not be administered for US sites.
Drug: Drug: CLL/SLL SoC
Drug: CLL/SLL SoC will be administered orally/ intravenously.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Andrew Sochacki
Status
Will Be Recruiting
Condition(s) Treated at Site