[18F]LY4214835 for Cancer

Not yet recruiting at 4 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: Pregnancy, Breastfeeding, Heart failure, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, [18F]LY4214835, to evaluate its safety and tolerability. It involves two groups: one with cancer patients who either have not received major treatment or whose cancer has worsened after treatment, and another with healthy individuals. Participants with cancer must have a visible and measurable tumor. The drug is administered through an IV, and participation lasts about 35 days. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not be actively receiving cancer therapy or be in between cycles of treatment.

Is there any evidence suggesting that [18F]LY4214835 is likely to be safe for humans?

Research on [18F]LY4214835 remains in the early stages, focusing on its safety for people. As a Phase 1 trial, the main goal is to assess the treatment's safety and tolerability. Although specific data from previous studies is unavailable, reaching this phase indicates initial confidence in its safety. Typically, Phase 1 trials proceed only if earlier tests suggest the treatment is not harmful. Participants will receive the treatment through an IV (a needle in a vein) and will be closely monitored for any side effects. The trial will help researchers gather more detailed safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about [18F]LY4214835 for cancer because it uses a novel radioactive tracer to potentially improve the precision of detecting tumors. Unlike traditional treatments that mainly focus on shrinking or killing cancer cells, this approach aims to enhance imaging techniques, helping doctors pinpoint cancer more accurately. The intravenous administration of this tracer could lead to earlier and more accurate diagnoses, which is crucial for effective treatment planning. This innovative approach represents a shift from conventional methods, offering hope for more targeted and successful cancer management.

What evidence suggests that [18F]LY4214835 might be an effective treatment for cancer?

Research has shown that [18F]LY4214835, like other substances such as 18F-FDG, is used in PET/CT scans to help doctors assess cancer activity. In previous studies, these scans changed treatment plans for about a third of patients, highlighting their potential impact. The scans offer important insights into cancer aggressiveness by observing sugar usage. Although direct data on [18F]LY4214835 is limited, it is expected to function similarly, providing valuable information about cancer traits. This can help doctors make more informed treatment decisions. Participants in this trial will receive [18F]LY4214835 to evaluate its effectiveness in providing such insights. ^{1 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 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 study is open to healthy individuals and those with cancer. Participants will receive an intravenous injection of the study drug, [18F]LY4214835, and their participation will last about 35 days.

Inclusion Criteria

* Cohort 2

* Cohort 1

* Are overtly healthy at the Screening Visit and upon reporting to the clinic for the positron emission tomography (PET) Imaging Visit, as determined by medical evaluation including updated medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive [18F]LY4214835 intravenously to evaluate safety and biodistribution

3 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]LY4214835

Trial Overview [18F]LY4214835 is being tested for safety and tolerability when given as an IV injection to both healthy volunteers and people with cancer. The trial aims to understand how the body handles this new substance.

How Is the Trial Designed?

Group I: LY4214835 (Cohorts 1 and 2) Experimental Treatment 1 Intervention

LY4214835 administered intravenously (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/NCT07258836?term=NA

A Study of [18F]LY4214835 in Healthy Volunteers and ... The purpose of the study is to check how safe and well-tolerated [18F]LY4214835 injection is in healthy participants and participants with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34742159/

Impact of 18 F-Fluorodeoxyglucose positron emission ... Approximately, a third of patients had their management changed because of FDG-PET or PET/CT results, and this finding was consistent across numerous subgroups.

3. mdpi.com mdpi.com/2072-6694/16/14/2525

18 F-Fluorodeoxyglucose Positron Emission Tomography ... F-FDG PET/CT offers significant prognostic insights by reflecting the metabolic characteristics of cancer. Employing these 18F-FDG PET features, ...

4. researchgate.net researchgate.net/publication/373371830_Clinical_Utility_of_Pre-Therapeutic_18FFDG_PETCT_Imaging_for_Predicting_Outcomes_in_Breast_Cancer

(PDF) Clinical Utility of Pre-Therapeutic [18F]FDG PET/CT ... After a median follow-up of 4.5 years, 65 patients experienced recurrence and 39 patients died. High TMTV (>13.5 cm3) was associated with ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26828141/

Skeletal Tumor Burden on Baseline 18F-Fluoride PET/CT ... 223Ra was beneficial and reduced the risk of death even in patients with a high skeletal tumor burden. Fluoride PET/CT is able to determine which patients ...

6. reporter.nih.gov reporter.nih.gov/search/BU3SrB8MKkef_hKVQ3UNaA/project-details/11179845

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. cinj.org cinj.org/favorable-safety-profile-seen-immunotherapy-drug-aggressive-form-lung-cancer

Immunotherapy Drug for Aggressive Lung Cancer Safety Profile The immunotherapy drug pembrolizumab has demonstrated a favorable safety profile and “promising durable clinical activity” in pretreated patients.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06887348

NCT06887348 | A Study to Assess the Long-term Safety ... Not yet recruiting. A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 (RPx).

9. dana-farber.org dana-farber.org/clinical-trials/22-173

A PHASE 1A/1B STUDY TO EVALUATE THE SAFETY ... This is a phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in ...