Phase 1a1b Study to Test Safety and Effects of UBX-303061 in Adults with Relapsed or Refractory B-Cell Cancers

What this Trial Is About

Researchers are evaluating UBX-303061, an investigational oral drug, in patients with relapsed or refractory B-cell malignancies. This first-in-human Phase 1a1b open-label study aims to assess the safety and anti-cancer activity of UBX-303061 in individuals who have already received at least two prior therapies or have no available treatment options. The study is sponsored by Ubix Therapeutics, Inc. and focuses on determining the drugs maximum tolerated dose and pharmacokinetics. Participants will receive UBX-303061 in a dose-escalation phase Phase 1a followed by a dose-expansion phase Phase 1b to further evaluate safety and effectiveness. Treatment duration can last up to 9 months, with monitoring for dose-limiting toxicities, dose interruptions, and reductions. The study also examines genetic markers related to B-cell malignancies and collects pharmacodynamic data during the treatment period. During the trial, participants will undergo regular safety assessments, laboratory tests, and evaluations of tumor response based on the appropriate criteria for their disease type. Researchers will track adverse events and pharmacokinetic parameters such as drug concentration over time. The study will last up to 9 months per participant, with ongoing monitoring to understand UBX-303061s effects and tolerability in this patient population.

UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies