Phase 1 Study Evaluating Oral JNJ-95804306 in Relapsed or Refractory Blood Cancers Including AML, MDS, CLL, SLL, and NHL

What this Trial Is About

Researchers are evaluating JNJ-95804306 for people with relapsed or refractory hematological malignancies, which are cancers starting in blood-forming tissues or immune system cells. The study includes two parts Part 1 focuses on finding a safe and tolerable dose of JNJ-95804306, while Part 2 further assesses its safety and anti-tumor activity alone or combined with standard care treatments. This phase 1 trial aims to identify suitable dose regimens and understand how the drug works in different blood cancers like AML, MDS, CLL, SLL, and NHL. Participants receive JNJ-95804306 orally. In Part 1, dose escalation is used to determine the recommended phase 2 dose RP2D. Part 2 involves dose expansion, where participants receive JNJ-95804306 alone or with standard of care SoC therapies at the identified doses, depending on their specific cancer type. For U.S. sites, only JNJ-95804306 monotherapy is given without SoC. The study includes different arms based on cancer type and treatment combination, monitoring various regimens and their effects. During the trial, participants undergo assessments for safety, including monitoring for dose-limiting toxicities up to 28 days after the first full dose and tracking adverse events for over six years. Researchers evaluate anti-tumor responses using specific criteria for each cancer type, including complete and overall responses. Blood samples are taken to measure drug concentrations and pharmacokinetics. Participants health status is regularly checked, and safety is closely monitored throughout the study, which may last several years.

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