24 Participants NeededMy employer runs this trial

Olomorasib Administration Methods for Healthy Subjects

Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how olomorasib, a new treatment, enters the bloodstream when administered in different ways. Researchers aim to determine the most effective method and monitor for any side effects. Participants must stay at the study site for a week during the trial. This trial suits healthy individuals who can commit to a 7-night stay and have no serious medical conditions. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that olomorasib is likely to be safe for humans?

Research has shown that olomorasib is generally well-tolerated. The most common mild side effects included diarrhea and changes in liver function tests. Specifically, 31% of participants experienced diarrhea, while 26% and 24% showed increased levels of ALT and AST, respectively, which indicate liver health. Notably, only 1% of participants discontinued olomorasib due to side effects. This suggests that olomorasib is relatively safe, with manageable side effects for most people.12345

Why are researchers excited about this trial?

Olomorasib is unique because researchers are exploring different administration methods to optimize its effectiveness and safety. Unlike other treatments that might focus on intravenous or topical applications, Olomorasib is administered orally, which could enhance patient convenience and adherence. This trial could reveal insights into how different oral formulations impact absorption and efficacy, potentially leading to improved therapeutic outcomes. Researchers are excited about this trial as it could pave the way for more patient-friendly treatment options without compromising on the effectiveness.

What evidence suggests that olomorasib could be effective?

Research has shown that olomorasib may help treat certain cancers with a specific genetic change called KRAS G12C. In lung cancer patients with this mutation, olomorasib shrank tumors in 77% of cases. When combined with other cancer treatments like cetuximab, the overall response rate was 45%, and disease control reached 92%. These results suggest that olomorasib could effectively manage cancers with the KRAS G12C mutation, though further research is needed to fully understand its potential. In this trial, researchers are studying olomorasib in healthy subjects to evaluate different administration methods.678910

Who Is on the Research Team?

C1

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 healthy adults who do not have any significant medical conditions. Participants should be generally well and able to stay in a clinical research unit for about one week.

Inclusion Criteria

Able to comply with the 7-night stay at the study site
Have a body mass index (BMI) within the range 18.0 to 30.0 kilograms per square meter (kg/m2)
I am in good health based on my recent medical checkups and tests.
See 1 more

Exclusion Criteria

Have evidence of hepatitis B at screening including positive test for hepatitis B surface antigen, Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) or both
Have a positive hepatitis C antibody test unless a confirmatory HCV RNA test is negative
Have an abnormal blood pressure or pulse rate
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Olomorasib in two different ways to compare absorption and side effects

6 weeks
1 stay in the Clinical Research Unit (CRU) for 7 nights

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Olomorasib

Trial Overview

The study compares two different ways of taking the drug olomorasib to see how much and how quickly it enters the bloodstream. Each participant will try both methods during a roughly 6-week period, including a short hospital stay.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Olomorasib testExperimental Treatment1 Intervention
Group II: Olomorasib referenceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

Efficacy and safety of LY3537982, a potent and highly ...

... Improved preliminary efficacy was observed when olomorasib was combined with cetuximab, with ORR and DCR reaching 45% and 92%, respectively, and a higher ...

Treating KRAS G12C lung cancer: therapeutic potential of ...

In the case of divarasib, 95% of patients experienced TRAEs, with the most common being grade 1–2 nausea, diarrhea, and vomiting [Citation16].

Long-Term Data for PHAROS Show Half of Treatment ...

A mini oral session at ESMO of targeted therapy in non-small cell lung cancer included treatments that showed effectiveness in brain metastases.

Lilly's olomorasib receives US FDA's Breakthrough Therapy ...

Growing evidence suggests outcomes for patients with KRAS G12C-mutant pancreatic cancer are worse than those without the mutation, underscoring a persistent gap ...

Development of KRAS Inhibitors and Their Role for ...

In results presented at the 2024 ASCO Annual Meeting, an RR of 77% was observed in patients with KRASG12C-mutant NSCLC treated with olomorasib ...

A Study of First-Line Olomorasib... | Clinical Trial

Common adverse events included diarrhea, fatigue, and increased ALT levels, with manageable safety profiles observed across both cohorts.

First-line (1L) olomorasib + pembrolizumab in patients with ...

Across all treated pts the most common any grade treatment-related adverse events (TRAEs) were diarrhea (31%) and ALT/AST increased (26/24%).

Eli Lilly's Latest Cancer Win Comes With a Big Caveat

Treatment-related side effects were largely mild, and only 1% discontinued olomorasib because of toxicity.

First-line (1L) olomorasib + pembrolizumab in patients with ...

Across all treated pts the most common any grade treatment-related adverse events (TRAEs) were diarrhea (31%) and ALT/AST increased (26/24%).

Amplia Signs Collaboration Agreement With Lilly ...

In studies to date, olomorasib has demonstrated an efficacy and safety profile that has supported later stage clinical development, with Lilly