LY4066434 for Solid Tumors

Recruiting at 68 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Eli Lilly and Company

Disqualifiers: Active CNS metastases, Cardiovascular disease, Active hepatitis, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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 metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.

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.

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 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 cancer has a specific KRAS mutation.

I am fully active or can carry out light work.

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

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.

Trial Timeline

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

Treatment Details

Interventions

• LY4066434 (Small Molecule Inhibitor)

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.

Participant Groups

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