LY4066434 for Solid Tumors

Recruiting at 80 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 CNS metastases, Cardiovascular disease, Active hepatitis, others

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

Compensation: Varies

Number of Visits: Unknown

750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety of a new drug, LY4066434, for individuals with certain advanced or metastatic solid tumors that have specific KRAS mutations. Researchers will test the drug in varying doses, either alone or with other treatments, to identify the most effective and safe usage. Suitable candidates for this trial have a confirmed diagnosis of a solid tumor that cannot be surgically removed or has metastasized, along with specific KRAS mutations. Participants must be able to swallow tablets, and the study may include individuals with treated or symptom-free brain conditions. As a Phase 1 trial, this research focuses on understanding the drug's effects in humans, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it is common for clinical trials to have specific guidelines about medication use, so it's best to discuss this with the trial coordinators.

Is there any evidence suggesting that LY4066434 is likely to be safe for humans?

Early lab studies have shown that LY4066434 targets specific changes in a gene called KRAS, which can influence cancer growth. These studies help scientists understand the drug's mechanism, but they do not fully determine its safety for humans.

As this is an early-stage trial, the primary goal is to assess the safety of LY4066434 when used alone or with other treatments. This marks the first time the drug is tested in humans, so safety information is limited. Participants in the trial will provide researchers with crucial safety data. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solid tumors that often rely on chemotherapy, LY4066434 is unique because it is administered orally, offering a potentially more convenient option for patients. This investigational drug is being explored both as a monotherapy with escalating doses and in combination with another investigational agent, which could enhance its efficacy. Researchers are excited about LY4066434 because it may offer a new mechanism of action against solid tumors, potentially improving outcomes where current options are limited.

What evidence suggests that LY4066434 might be an effective treatment for solid tumors?

Research has shown that LY4066434 targets specific changes in the KRAS gene found in many solid tumors. These changes often cause tumors to grow, making them important to treat. Although human studies provide limited information, early lab research suggests LY4066434 can block these changes, potentially slowing cancer growth. Initial results from related studies are promising, with LY4066434 sometimes reducing tumor sizes. In this trial, participants will receive LY4066434 either as monotherapy in a dose escalation format or in a dose optimization format, potentially with another investigational agent. More research is needed to confirm these effects, but focusing on KRAS changes offers hope for treating these difficult cancers. ^{1 2 3 6 7}

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 with advanced solid tumors like pancreatic, lung, or colorectal cancer that can't be surgically removed and have specific KRAS mutations. They should be able to perform daily activities with ease (ECOG ≤1), swallow pills, and not be pregnant or breastfeeding.

Inclusion Criteria

My brain condition is stable, treated, or causes no symptoms.

My cancer has a specific KRAS mutation.

I am fully active or can carry out light work.

Exclusion Criteria

I do not have any ongoing serious infections.

I have cancer that has spread to my brain or the linings of my brain.

I have another cancer but it's in remission and I'm expected to live more than 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Escalation

Escalating doses of LY4066434 administered orally to determine safety and tolerability

Up to approximately 5 years

Dose Optimization

LY4066434 administered orally either alone or with another investigational agent to optimize dosing

Up to approximately 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4066434

Trial Overview

The study tests the safety of LY4066434 alone or combined with other cancer drugs over a period of up to 5 years. It includes two phases: finding the right dose and then seeing how well it works at that dose in participants.

How Is the Trial Designed?

Group I: LY4066434 Monotherapy Dose Escalation Experimental Treatment 1 Intervention

Escalating doses of LY4066434 administered orally.

Group II: LY4066434 Dose Optimization Experimental Treatment 12 Interventions

LY4066434 administered orally either alone or with another investigational agent.

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/NCT06607185

NCT06607185 | A Study of the Pan-KRAS Inhibitor ...

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/EDBK-25-473204

Treatment Innovations in Pancreatic Cancer

... LY4066434 in Participants With KRAS Mutant Solid Tumors ... solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial.

3.

mayo.edu

mayo.edu/research/clinical-trials/cls-20582562

A Study Of The Pan-KRAS Inhibitor LY4066434 In ...

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or ...

4.

trials.lilly.com

trials.lilly.com/en-US/trial/533775

A Study of the Pan-KRAS Inhibitor LY4066434 in ... - Lilly Trials

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced ...

5.

mskcc.org

mskcc.org/cancer-care/clinical-trials/25-001

A Phase 1 Study of LY4066434 in People With KRAS- ...

Researchers want to find the best dose of LY4066434 when given alone and with other drugs to treat solid tumors.

6.

cancer.gov

cancer.gov/clinicaltrials/NCI-2025-00398

A Study of the Pan-KRAS Inhibitor LY4066434 in ...

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced ...

7.

lillyoncologypipeline.com

lillyoncologypipeline.com/molecule/pan-kras-inhibitor/

Pan-KRAS Inhibitor Molecule Overview - HCP

In preclinical studies, scientists have observed that LY4066434 inhibition includes, but is not limited to, KRAS G12D, G12V, G12C, G13D, G12A, and G12S.