LOXO-338 for Blood Cancers

Recruiting at 22 trial locations

Overseen By Patient Advocacy

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

316 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, LOXO-338, to treat advanced blood cancer in patients who haven't responded to standard treatments. If effective alone, it will also be tested with another drug, pirtobrutinib, to see if the combination works better.

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

Eligibility Criteria

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

You must have a type of cancer that starts in your B-cells.

You have received treatment before.

You are able to perform daily activities without any major issues.

Exclusion Criteria

You have had AL amyloidosis in the past.

Living outside the US

You have had diffuse large B-cell lymphoma in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Treatment with LOXO-338 Monotherapy

Evaluation of LOXO-338 as monotherapy to determine maximum tolerated dose and preliminary antitumor activity

Estimated up to 2 years

Part 2: Combination Treatment with LOXO-338 and Pirtobrutinib

Evaluation of LOXO-338 in combination with pirtobrutinib for safety, tolerability, and antitumor activity

Estimated up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LOXO-338
• Pirtobrutinib

Trial Overview The trial is testing LOXO-338's safety and effectiveness in treating various types of advanced blood cancers over approximately three years. Some patients may also receive Pirtobrutinib as part of their treatment regimen. The goal is to determine how well these drugs work after standard treatments have been tried.

Participant Groups

Group I: LOXO-338 + Pirtobrutinib (Combination) Experimental Treatment 2 Interventions

LOXO-338 administered orally in combination with pirtobrutinib

Group II: LOXO-338 (Monotherapy) Experimental Treatment 1 Intervention

LOXO-338 administered orally.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

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

Trials

72

Recruited

11,600+

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