Olomorasib Administration Methods for Healthy Subjects
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?
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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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Olomorasib in two different ways to compare absorption and side effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Olomorasib administered orally
Olomorasib administered orally
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
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 ...
6.
trial.medpath.com
trial.medpath.com/clinical-trial/b10241bf28c33da8/nct06119581-kras-g12c-lung-cancer-ly3537982-pembrolizumab-trialA 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%).
8.
finance.yahoo.com
finance.yahoo.com/healthcare/articles/eli-lillys-latest-cancer-win-174738823.htmlEli 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
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