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

What this Trial Is About

Researchers are evaluating JNJ-95804306 in people with relapsed or refractory hematological malignancies, including acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). The study aims to find the safest and most suitable dose of JNJ-95804306 and to assess its anti-tumor activity alone or combined with standard of care therapies. This is a Phase 1, first-in-human, dose escalation and expansion study conducted by Janssen Research & Development, LLC. Participants receive JNJ-95804306 orally either alone or with standard treatments depending on their specific cancer type and study arm. Part 1 involves dose escalation to identify the recommended phase 2 dose (RP2D), while Part 2 expands the study to further evaluate safety and anti-tumor effects at the identified dose(s). For US sites, only JNJ-95804306 monotherapy is given, without standard of care drugs. Treatment groups include those with AML/MDS and those with CLL/SLL, with variations in combination therapy. During the study, participants are closely monitored for dose-limiting toxicities and adverse events for up to six years and five months. Researchers will assess blood samples to measure drug levels and evaluate responses such as complete response and overall response rates in different blood cancers. The study involves regular clinical assessments, safety monitoring, and long-term follow-up to understand treatment impact and tolerability.

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