LY4337713 for Cancer

(FiREBOLT Trial)

Recruiting at 19 trial locations

Overseen By Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: CNS metastases, Myelosuppression, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: up to 5 years

241 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY4337713, a potential drug for people with advanced cancers that have spread and show high levels of fibroblast activation protein (FAP). The main goals are to assess the safety and side effects of LY4337713 and evaluate its effectiveness. The trial will also study how the drug moves through the body. Participants might be suitable if they have specific types of cancer, such as pancreatic or breast cancer, and have already tried other treatments without success. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LY4337713 is likely to be safe for humans?

Research shows that the safety of LY4337713 in humans remains under investigation. As this study is in its early stages, detailed safety information is limited. Early trials typically assess a treatment's safety and determine the appropriate dose. Researchers closely monitor LY4337713 to evaluate tolerance and identify potential side effects. They pay particular attention to any unexpected health issues that may arise. If LY4337713 proves safe and well-tolerated, future studies will concentrate on its effectiveness against cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about LY4337713 because it introduces a novel approach to cancer treatment. Unlike traditional chemotherapy, which often targets rapidly dividing cells indiscriminately, LY4337713 is designed to target specific tumor types more precisely. This targeted approach could potentially lead to fewer side effects compared to standard treatments. Additionally, LY4337713 is administered intravenously in varying doses, allowing for a flexible treatment plan that can be tailored to individual patient needs.

What evidence suggests that LY4337713 might be an effective treatment for cancer?

Research has shown that LY4337713 targets cancers with high levels of fibroblast activation protein (FAP), a protein often present in certain advanced or spreading cancers. LY4337713 focuses on this protein, potentially stopping cancer cell growth. Early evidence suggests this method could be effective, as the treatment aims to target cancer cells without harming healthy ones. Although data from human studies remain limited, its interaction with cancer cells shows promise. ^{1 4 5 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 people with advanced or metastatic cancers like colorectal, breast, pancreatic, stomach, bile duct, ovarian, and esophageal cancer. Participants must have high levels of a protein called FAP in their tumors to join.

Inclusion Criteria

Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment

Measured creatinine clearance ≥60 milliliters per minute (mL/min)

My cancer is one of the specified types, including pancreatic, certain breast cancers, ovarian, or other listed solid tumors.

Exclusion Criteria

Have prolongation of the corrected QTcF >470 milliseconds (msec) during screening

I have a current, untreated blockage in my urinary tract.

I have had half or full-body radiation treatment before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation and Dose Optimization

Participants receive escalating doses of LY4337713 to evaluate safety, tolerability, and dosimetry

1 year

Treatment

Participants receive LY4337713 administered intravenously in tumor-specific cohorts

up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• LY4337713

Trial Overview The study tests LY4337713's safety and effectiveness on various cancers with high FAP levels. It also examines how the body processes this drug over an approximate five-year period per participant.

How Is the Trial Designed?

Group I: LY4337713 (Cohort E) Experimental Treatment 1 Intervention

Tumor specific cohort will receive LY4337713 administered IV.

Group II: LY4337713 (Cohort A2) Experimental Treatment 1 Intervention

Two or more dose regimens of LY4337713 (evaluated during dose escalation) administered IV.

Group III: LY4337713 (Cohort A1) Experimental Treatment 1 Intervention

Escalating doses of LY4337713 administered intravenously (IV).

Group IV: Experimental: LY4337713 (Cohort D) Experimental Treatment 1 Intervention

Tumor specific cohort will receive LY4337713 administered IV.

Group V: Experimental: LY4337713 (Cohort B) Experimental Treatment 1 Intervention

Tumor specific cohort will receive LY4337713 administered IV.

Group VI: Experimental LY4337713 (Cohort C) Experimental Treatment 1 Intervention

Tumor specific cohort will receive LY4337713 administered IV.

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/NCT07213791

NCT07213791 | A Study of LY4337713 in Participants With ... This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of ...

2. trials.lilly.com trials.lilly.com/en-US/trial/660077

A Study of LY4337713 in Participants With FAP ... - Lilly Trials This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of ...

3. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/35371022/eli-lillys-new-study-on-ly4337713-a-potential-game-changer-for-cancer-treatment/

Eli Lilly's New Study on LY4337713: A Potential Game ... The study aims to assess the safety, side effects, and efficacy of LY4337713 in participants with advanced or metastatic cancers that express ...

4. theranostictrials.org theranostictrials.org/studies/cl74bp9il0231ajjf2950vuef/study/NCT07213791

NCT07213791 The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the ...

5. lillyoncologypipeline.com lillyoncologypipeline.com/pipeline/?ct=Other%20Solid%20Tumors

Other Solid Tumors - Lilly Oncology Pipeline Database Review Lilly's oncology pipeline to see the current clinical trials for cancer patients, and to see whether or not we are accepting enrollments.

6. lillyoncologypipeline.com lillyoncologypipeline.com/molecule/Lu-177-FAP/

[Lu-177]-FAP Molecule Overview The safety and efficacy of the agents for uses under investigation have not been established. Pipeline molecules may not receive regulatory approval and become ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-ly4337713-in-participants-with-fap-positive-solid-tumors

A Study of LY4337713 in Participants With FAP-Positive Solid ... This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with ...