LOXO-338 for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, LOXO-338, to determine its safety and effectiveness for individuals with advanced blood cancers. The study consists of two parts: one where participants take LOXO-338 alone, and another where they take it with pirtobrutinib (also known as Jaypirca). It targets individuals who have already tried standard cancer treatments but require additional help. Eligible participants should have a B-cell blood cancer, have undergone previous treatments, and need ongoing therapy. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the LOXO-338 trial?
The trial requires that you stop any current anticancer therapy and certain medications like strong CYP3A4 inhibitors or inducers. If you're taking prednisone, you must not exceed 20 mg per day within 7 days of starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LOXO-338, when used alone, is generally safe for patients with advanced blood cancers, with few serious side effects. However, detailed safety information on the combination of LOXO-338 with pirtobrutinib is not yet available, as the current trial remains in an early stage. Researchers continue to monitor this combination closely for any safety issues. In summary, early research indicates that LOXO-338 alone is usually safe, while the safety of its combination with pirtobrutinib is still under careful study.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about LOXO-338 because it offers a new approach for treating blood cancers. Unlike standard treatments that rely on chemotherapy, LOXO-338 is a targeted therapy, designed to specifically attack cancer cells with potentially fewer side effects. LOXO-338 uses a novel mechanism of action, targeting specific proteins within cancer cells, disrupting their growth and survival. Additionally, the combination of LOXO-338 with pirtobrutinib is particularly promising, as it could enhance effectiveness by attacking cancer cells from multiple angles, possibly improving outcomes for patients who haven't responded well to traditional therapies.
What evidence suggests that this trial's treatments could be effective for advanced blood cancer?
Research has shown that LOXO-338, which participants in this trial may receive as monotherapy, may help treat advanced blood cancers. In studies where LOXO-338 was used alone, 19% of patients experienced tumor shrinkage, and 67% maintained stable disease. This indicates that some patients' cancer reduced in size, while many others did not experience progression. Lab studies demonstrated that LOXO-338 can block BCL2, a protein that aids cancer cell survival. Another treatment arm in this trial involves using LOXO-338 with pirtobrutinib. Early research suggests that this combination could effectively manage advanced blood cancers, as the two drugs target cancer cells in different ways.13678
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for US residents with advanced B-cell blood cancers who've had prior therapy, are in good physical condition (ECOG PS 0-1), and have a life expectancy of at least 12 weeks. They must be able to swallow pills, follow the study's outpatient requirements, and use effective birth control if necessary. Exclusions include certain lymphomas, CNS involvement, HIV positivity, recent major surgery or live vaccines, high-dose steroid use within a week of starting treatment, pregnancy or lactation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1: Treatment with LOXO-338 Monotherapy
Evaluation of LOXO-338 as monotherapy to determine maximum tolerated dose and preliminary antitumor activity
Part 2: Combination Treatment with LOXO-338 and Pirtobrutinib
Evaluation of LOXO-338 in combination with pirtobrutinib for safety, tolerability, and antitumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LOXO-338
- Pirtobrutinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead 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
Loxo Oncology, Inc.
Industry 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