Oral LOXO-305 for Chronic Lymphocytic Leukemia
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking any investigational agents or anticancer therapies at least 14 days before starting the study, and certain monoclonal antibody treatments must be stopped 4 weeks prior. You cannot take any concurrent systemic anticancer therapy during the trial.
What makes the drug LOXO-305 unique for treating chronic lymphocytic leukemia?
LOXO-305 is a novel treatment for chronic lymphocytic leukemia that may offer a different mechanism of action compared to existing therapies like Bruton tyrosine kinase inhibitors and Bcl-2 inhibitors, which are often used in combination. While specific details about LOXO-305's mechanism are not provided, its development suggests it could provide an alternative option for patients who may not respond to or tolerate current treatments.12345
What is the purpose of this trial?
This trial is testing pirtobrutinib, a tablet taken by mouth, in patients with certain types of blood cancers who haven't responded to or can't tolerate usual treatments. The medication works by blocking a protein that cancer cells need to grow. The study aims to find the best dose and see how well it works.
Research Team
Donald Tsai, MD, PhD
Principal Investigator
Loxo Oncology
Eligibility Criteria
This trial is for patients with certain blood cancers like CLL/SLL or NHL who have not responded well to standard treatments or are intolerant to them. They should be in a stable condition (ECOG 0-2), able to take oral medication, and willing to use effective birth control. People can't join if they've had major surgery recently, are pregnant, on warfarin therapy, have uncontrolled infections or other serious health issues, or have been treated with pirtobrutinib before.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Dose Escalation
Dose escalation and determination of maximum tolerated dose (MTD) with pirtobrutinib monotherapy
Phase 1 Dose Expansion
Participants receive the recommended Phase 2 dose of pirtobrutinib
Phase 1b Dose Expansion
Participants receive pirtobrutinib in combination with venetoclax and/or rituximab
Phase 2 Dose Expansion
Participants are enrolled into one of seven cohorts based on tumor histology and prior treatment history
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- LOXO-305
Find a Clinic Near You
Who Is Running the Clinical Trial?
Loxo Oncology, Inc.
Lead Sponsor
Jacob Van Naarden
Loxo Oncology, Inc.
Chief Executive Officer since 2019
A.B. in Molecular Biology from Princeton University
Dr. Jennifer Low
Loxo Oncology, Inc.
Chief Medical Officer since 2014
MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University