LY4584180 + Rituximab for Non-Hodgkin's Lymphoma

Not yet recruiting at 12 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Active second cancer, CNS involvement, Cytomegalovirus, Hepatitis B/C, HIV, Heart disease

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months or possibly longer

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and effectiveness of a new treatment, LY4584180, for individuals with certain types of non-Hodgkin's lymphoma. Researchers seek to determine how much of the drug enters the bloodstream and how quickly the body eliminates it. The trial involves administering LY4584180 alone or with another drug, rituximab. Suitable candidates have previously received treatment for blood cancers like diffuse large B-cell lymphoma and have tried at least two other therapies. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial requires that you stop all previous cancer treatments and recover from their immediate effects before participating. It doesn't specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that LY4584180 remains in the early stages of testing to determine its safety and efficacy in people. As this is a Phase 1 trial, researchers closely monitor any side effects and assess how well participants tolerate the treatment.

For the combination of LY4584180 and rituximab, previous studies on rituximab have identified some common side effects. These include mild to moderate reactions such as fever, chills, and nausea, often occurring during the first treatment. More serious reactions can occur but are less common.

Overall, the main goal of this Phase 1 trial is to find the right dose and monitor for any side effects. Participants will be closely observed to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LY4584180 for Non-Hodgkin's Lymphoma because it offers a novel approach distinct from the current standard of care, which often involves chemotherapy and immunotherapy with drugs like rituximab. LY4584180 is unique as it is administered orally, providing a potentially more convenient treatment option compared to the intravenous options typically used. Additionally, this treatment is being explored both as a monotherapy and in combination with rituximab, which could enhance its effectiveness by leveraging multiple mechanisms of action. This dual approach might offer better outcomes for patients who do not respond adequately to existing therapies.

What evidence suggests that this trial's treatments could be effective for Non-Hodgkin's Lymphoma?

Studies have shown that rituximab, when combined with other treatments, effectively treats non-Hodgkin's lymphoma. One study found that 92% of patients responded well to this combination, demonstrating its high effectiveness. Rituximab targets a protein on the surface of lymphoma cells, aiding in their destruction. In this trial, some participants will receive LY4584180 as monotherapy, while others will receive it in combination with rituximab. Although no published data exists yet on LY4584180 specifically, its combination with rituximab appears promising based on rituximab's proven success. ^{6 7 8 9 10}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 adults who have had previous treatments for certain blood cancers, including mixed-cell lymphoma, diffuse large B-cell lymphoma, and various types of non-Hodgkin's lymphoma. Participants should be past initial therapies but still need treatment.

Inclusion Criteria

My cancer can be measured by tests.

I have had at least 2 treatments for my type of lymphoma or am not eligible for current treatments.

I have stopped all cancer treatments and recovered from their immediate side effects.

Exclusion Criteria

Has known Cytomegalovirus infection. Participants with negative status are eligible

I have a serious heart condition.

I have another type of cancer that is currently active.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4584180 monotherapy or combination therapy with rituximab

9 months or possibly longer

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• LY4584180
• Rituximab

Trial Overview The study tests LY4584180's safety and effectiveness in treating blood cancers. It also measures the drug levels in the bloodstream and how quickly it's cleared from the body. Patients will receive LY4584180 with Rituximab over approximately 9 months or more.

How Is the Trial Designed?

Group I: Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B4) Experimental Treatment 1 Intervention

LY4584180 monotherapy administered orally

Group II: Phase 1b-Dose Expansion-Combination (Cohort B5) Experimental Treatment 2 Interventions

LY4584180 administered orally in combination with rituximab administered through IV infusion

Group III: Phase 1a-Optional Monotherapy Dose Optimization (Cohort A2) Experimental Treatment 1 Intervention

LY4584180 monotherapy administered orally

Group IV: Phase 1a-Monotherapy Dose Escalation (Cohort A1) Experimental Treatment 1 Intervention

LY4584180 monotherapy 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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226843?aggFilters=funderType%3Aindustry%2Cstatus%3Anot%2CstudyType%3Aint&start=2025-01-01_

A Study of LY4584180 in Adult Participants With Previously ... Other non-Hodgkin lymphoma. Has measurable disease; Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5710919/

Comparative efficacy of different chemotherapies for non- ... Overall survival (OS) and complete remission (CR) were considered as main outcome indicators to evaluate the efficacy of NHL chemotherapies.

3. ichgcp.net ichgcp.net/clinical-trials-registry/554047-a-pharmacokinetic-study-of-yn001-in-healthy-participants

YN001 Clinical Trial: Pharmacokinetic Study in Healthy ... This clinical research study focuses on understanding how a new investigational drug called YN001 behaves inside the human body.

4. researchgate.net researchgate.net/publication/360216478_Study_Of_Treatment_Efficacy_In_Non_Hodgkin's_Lymphoma_With_Respect_To_Radio-Pathological_Correlation

Study Of Treatment Efficacy In Non Hodgkin's Lymphoma ... At the end of the study period, 78 % were in remission, 10% cases in relapse, 6% cases had progressive disease and 6% of cases expired.

5. cancer.org cancer.org/cancer/types/non-hodgkin-lymphoma/detection-diagnosis-staging/factors-prognosis.html

Non-Hodgkin Lymphoma Survival Rate by Age The overall 5-year relative survival rate for people with NHL is 74%. But it's important to keep in mind that survival rates can vary widely for different ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07226843?lastUpdPost=2020-03-16_

A Study of LY4584180 in Adult Participants With Previously ... Other non-Hodgkin lymphoma. Has measurable disease; Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy.

7. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07226843

s and Lymphoma, Diffuse Large B-Cell - Clinical Trials Registry The main purpose of this study is to evaluate safety and efficacy, and measure how much LY4584180 gets into the bloodstream and how long it ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2833973/

B cell non-Hodgkin's lymphoma: rituximab safety experience The most common grade 1 or 2 toxicities were fever (18%), chills/rigors (26%), and nausea (21%). Almost all AEs occurred during the first rituximab infusion.

9. rituxan-hcp.com rituxan-hcp.com/nhl/efficacy/clinical-trial-results/relapsed-refractory.html

RITUXAN® (rituximab) Single-Arm Clinical Trial Results For ... BOXED WARNINGS · Infusion-related reactions: RITUXAN administration can result in serious, including fatal infusion-related reactions. · Severe Mucocutaneous ...

10. patlynk.com patlynk.com/trial/NCT00141700

Study of Rituximab Plus High-Dose Chemotherapy Poor ... This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, ...