240 Participants Needed

LY4175408 for Cancer

Recruiting at 23 trial locations
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Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY4175408 (an experimental treatment) for individuals with certain advanced cancers, such as some types of lung, breast, and endometrial cancer. Researchers aim to determine the treatment's safety, effectiveness, and how the body processes it. They are particularly interested in the drug's absorption into the bloodstream and its duration in the body. This trial seeks participants who have exhausted all standard cancer treatments available to them and still need other options. 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.

Do I have to stop taking my current medications for the trial?

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

Is there any evidence suggesting that LY4175408 is likely to be safe for humans?

Research is ongoing to determine the safety of LY4175408 for people with advanced cancer. As the treatment is in early testing stages, clear safety information is not yet available. Researchers are currently identifying the best dose and monitoring for side effects.

While it is too early to assess tolerance to LY4175408, these early trials aim to establish safe dosage levels and identify any potential negative effects. Participants in these studies receive close monitoring to ensure their safety. It is important to note that treatments in early trials often have limited safety information, as researchers continue to collect data.12345

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments that often involve chemotherapy or targeted therapies, LY4175408 stands out due to its innovative mechanism of action. Most treatments attack cancer cells directly, whereas LY4175408 is designed to leverage the body's immune system to target and destroy cancer cells more precisely. This approach could potentially result in fewer side effects compared to traditional chemotherapy, which can harm healthy cells. Researchers are excited because LY4175408's unique intravenous administration is being tested for both optimal dosing and effectiveness, aiming to maximize benefits while minimizing risks.

What evidence suggests that LY4175408 might be an effective treatment for cancer?

Research has shown that LY4175408 could be a promising treatment for some advanced cancers. This drug combines an antibody with a cancer-fighting agent, specifically targeting and destroying cancer cells. Early lab and animal studies demonstrated its effectiveness against tumors with the PTK7 protein, common in many cancers. These studies showed positive results, particularly for triple-negative breast cancer, which does not respond to certain hormone treatments. Although human studies remain limited, these initial findings suggest potential effectiveness for advanced cancers with PTK7. Participants in this trial will receive LY4175408 in various dosing regimens to evaluate its safety and effectiveness.13567

Who Is on the Research Team?

C1

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 individuals with advanced stages of various cancers, including lung, endometrial, breast, and pancreatic cancer. Participants should have a specific type of these cancers to join the study. The full eligibility criteria are not provided here.

Inclusion Criteria

I have advanced or metastatic cancer, specifically NSCLC, SCLC, endometrial, or triple negative breast cancer.
I have either completed all standard treatments, refused them, or there are none available for my condition.
I can carry out all my self-care but cannot do heavy physical work.
See 1 more

Exclusion Criteria

I do not have uncontrolled brain metastases.
I have had lung inflammation or scarring before.
I do not have any active, uncontrolled infections.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Dose Escalation

Escalating doses of LY4175408 administered intravenously (IV) to determine safety and optimal dosing

Varies

Phase 1a Dose Optimization

Two or more doses of LY4175408 (evaluated during dose escalation) administered IV to optimize dosing

Varies

Phase 1b Dose Expansion

LY4175408 administered IV to further assess safety and efficacy in a larger cohort

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

  • LY4175408
Trial Overview The trial is testing LY4175408's safety and effectiveness in treating certain advanced cancers. It also studies how this drug behaves in the body regarding absorption, breakdown, and elimination over a period that could last up to four years.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Phase 1b Dose Expansion (Cohort B)Experimental Treatment1 Intervention
Group II: Phase 1a Dose Optimization (Cohort A2)Experimental Treatment1 Intervention
Group III: Phase 1a Dose Escalation (Cohort A1)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

A Study of LY4175408 in Participants With Advanced CancerThe purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will ...
A Study of LY4175408 in Participants With Advanced CancerThe purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will ...
Anti-lipolysis-stimulated lipoprotein receptor antibody-drug ...This study used MDA-MB-231 and 4T1 cell lines for in vitro anti-cancer cytotoxicity assays and in vivo anti-TNBC efficacy evaluations.
PTK7 Antibody-Drug Conjugate Molecule - Learn MoreIt has a drug-antibody ratio (DAR) of 8:1. In preclinical models, LY4175408 has shown activity against a range of PTK7-expressing tumors, including low and ...
Conjugates dominate human trial entries | ApexOncoThe first-in-human study of LY4175408 starts this month, and makes this molecule the sixth anti-PTK7 ADC to enter clinical development. Two of ...
ly4175408 ptk7 antibody-drug conjugateThe safety and efficacy of the agents for uses under investigation have not been established. Pipeline molecules may not receive regulatory approval and ...
LY4175408 for Cancer · Recruiting Participants for Phase ...The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will ...
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