LY3866288 for Healthy Subjects

Overseen By This is a single site clinical trial 1-877-CTLILLY (1-877-285-4559) or

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Pregnancy, Drug abuse, Significant diseases, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LY3866288, to understand how the body processes it when administered orally or intravenously. Researchers aim to determine how much of the drug appears in the blood, urine, feces, and breath, and how long it remains in the body. The study also evaluates the drug's safety and tolerability in healthy participants. Ideal candidates for this trial are generally healthy individuals with no history of drug or alcohol abuse in the past two years. 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 drug.

Do I need to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for healthy participants, it's likely that you should not be on any significant medications. Please check with the trial organizers for specific guidance.

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

Research has shown that LY3866288, also known as LOXO-435, is generally safe. In studies where participants took 200 mg twice daily or more, LY3866288 was well-tolerated, with most individuals not experiencing serious side effects. The treatment remains in early trials, primarily focusing on safety assessment. This provides some initial confidence in its safety for humans, but further research is necessary for confirmation. Participants in this study are healthy individuals who will be closely monitored for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LY3866288 because it introduces a novel approach to treating conditions through its unique formulation. Unlike traditional treatments, LY3866288 utilizes a radiolabeled compound, [¹⁴C]-LY3866288, which allows for precise tracking of the drug's movement and metabolism in the body. This dual administration method—oral and intravenous—provides valuable insights into the drug's absorption and distribution, paving the way for potentially more effective and personalized treatment strategies. The combination of these features makes LY3866288 a promising candidate in the realm of new therapies.

What evidence suggests that this trial's treatments could be effective?

This trial will study LY3866288, also known as LOXO-435, in healthy subjects. Research has shown that LY3866288 is a promising new drug designed to block FGFR3, a protein that can promote cancer growth when altered. Studies have found it effective in treating cancers with FGFR3 gene changes, such as some solid tumors and bladder cancer. This treatment is highly targeted, aiming to reduce side effects by focusing only on the FGFR3 protein. Early results indicate that LY3866288 is safe and tolerable, offering a potential new way to treat cancers with FGFR3 changes. While more information is needed, current evidence is hopeful about its effectiveness. ^{3 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

This trial is for healthy men and women with a BMI between 18.0 and 32.0 kg/m^2, who pass medical exams including ECGs and lab tests. Men must be infertile (via surgery), while non-childbearing women must use contraception.

Inclusion Criteria

* Male and female participants who are overtly healthy determined by medical history, physical examination, 12-lead ECGs, vital signs measurements, and clinical laboratory evaluations at screening and/or check-in by the investigator * Have Body mass index between 18.0 and 32.0 kg/m\^2 (kilograms per meter squared)

I am a woman not able to bear children and I use birth control.

I am a male and infertile due to having had surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Part A: Treatment

Single dose of [14C]-LY3866288 administered orally to evaluate absorption, metabolism, and excretion

Approximately 4 weeks

1 visit (in-patient)

Part B: Treatment

Single dose of LY3866288 administered orally followed by a single dose of [14C]-LY3866288 administered intravenously

Approximately 4 weeks

1 visit (in-patient)

Follow-up

Participants are monitored for safety and tolerability after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [14C]-LY3866288
• LY3866288

Trial Overview [14C]-LY3866288, a study drug marked with radioactive carbon (14C), is being tested to see how it's processed by the body when taken orally or injected into the vein—how much enters blood, urine, feces, air expelled from lungs, its breakdown and elimination time.

How Is the Trial Designed?

Group I: Part B: LY3866288 + [14C]-LY3866288 Experimental Treatment 2 Interventions

Single dose of LY3866288 administered orally followed by a single dose of \[¹⁴C\]-LY3866288 administered intravenously (IV).

Group II: Part A: [14C]-LY3866288 Experimental Treatment 1 Intervention

Single dose of \[¹⁴C\]-LY3866288 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/NCT05614739

FORAGER-1: A Study of LOXO-435 (LY3866288) in ... The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other ...

2. urotoday.com urotoday.com/conference-highlights/asco-gu-2025/asco-gu-2025-bladder-cancer/158302-asco-gu-2025-a-first-in-human-phase-1-study-of-ly3866288-loxo-435-a-potent-highly-isoform-selective-fgfr3-inhibitor-fgfr3i-in-advanced-solid-tumors-with-fgfr3-alterations-initial-results-from-forager-1.html

A First-in-Human Phase 1 Study of LY3866288 (LOXO-435 ... In this report, the study investigators presented the initial phase Ia dose escalation results from FORAGER-1, a phase Ia/b study of LY3866288 ...

3. clinicaltrial.be clinicaltrial.be/en/details/189387?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

A Study of LOXO-435 (LY3866288) in Participant... This is an open-label, multi-center, phase 1 study in participants with FGFR3-altered advanced solid tumor malignancy including metastatic urothelial cancer ...

4. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/5376

A Study of LOXO-435 (LY3866288) in Participants With ... Tests the safety of a drug in healthy volunteers or subjects with indications. The aim is to find the best dose of a new drug with the fewest side effects ...

5. cancer.iu.edu cancer.iu.edu/patients/clinical-trials/66188

CTO-LOXO-FG3-22001: Clinical Trial Information FORAGER-1: A Phase 1, Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer with ...

6. ucihealth.org ucihealth.org/clinical-trials/UCI-24-159

A Phase I, Open-Label, Multicenter Study of LOXO-435 ... The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05614739

NCT05614739 | FORAGER-1: A Study of LOXO-435 ... The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other ...

8. lillyoncologypipeline.com lillyoncologypipeline.com/molecule/fgfr3-inhibitor/

FGFR3 Inhibitor - LOXO-435 Molecular Insights For HCPs LOXO-435 is a next-generation FGFR3 inhibitor. Read this article to learn more about how it works and its clinical development.

9. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/367675

FORAGER-1: A Study of LOXO-435 (LY3866288) in ... The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other ...