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New antibody drug takes aim at Hard-to-Treat cancers

NCT ID NCT07046923

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new drug called LY4175408, which is designed to seek out and attack cancer cells that have a specific marker (PTK7). The study includes 240 people with advanced lung, endometrial, or triple-negative breast cancers that have not responded to standard treatments. The main goals are to check safety, find the right dose, and get an early look at whether the drug can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY4175408 (an antibody drug conjugate that targets PTK7 on tumor cells, given by IV infusion, sometimes with pembrolizumab, carboplatin, or cisplatin)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced lung, endometrial, or triple-negative breast cancers that have stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 trial, so the drug may not be safe or effective. Side effects are unknown, and the study is small (240 people) with no guarantee of benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have one of the following advanced or metastatic solid tumor cancers: * Non-small cell lung cancer (NSCLC) * Small cell lung cancer (SCLC) * Endometrial cancer * Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines). * Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator (except in Cohort B1 and B2 expansion, which require participants who are treatment naive in the advanced metastatic setting); OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. * Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (≤) 1. * For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B/C): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Cohorts B1/B2: NSCLC with no known actionable genomic alterations. ≤2 prior lines of systemic therapy for advanced or metastatic disease in safety lead-in; no prior systemic therapy in expansion Exclusion Criteria: * Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted). Prior topoisomerase I-based ADCs are not allowed in cohorts A2, B1 or B2. * Any serious unresolved toxicities from prior therapy. * Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases. * Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection. * Significant cardiovascular disease. * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds (ms) * History of pneumonitis/interstitial lung disease. * Individuals who are pregnant, breastfeeding, or plan to breastfeed during the trial or within 30 days of the last dose of trial intervention.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm metastatic neoplasm Neoplasm Metastasis non-small cell lung carcinoma small cell lung carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung Endometrial neoplasms Neoplasm metastasis Small cell lung carcinoma Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Institute Hospital of JFCR

    RECRUITING

    Tokyo, 135-8550, Japan

  • Centre Leon Berard

    RECRUITING

    Lyon, 69373, France

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Community Health Network

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute

    RECRUITING

    Orlando, Florida, 32827, United States

  • Florida Cancer Specialists - Sarasota

    RECRUITING

    Sarasota, Florida, 34236, United States

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • John Theurer Cancer Center At Hackensack UMC

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kyoto University Hospital

    RECRUITING

    Kyoto, 606-8507, Japan

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, 104-0045, Japan

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Shanghai East Hospital, Tongji University

    NOT_YET_RECRUITING

    Shanghai, 0200120, China

  • Stanford Medicine Cancer Center

    RECRUITING

    Stanford, California, 94305, United States

  • The Ohio State University (OSU) Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Chicago Medical Center (UCMC)

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Tongji Hospital - Tongji Medical College of HUST

    NOT_YET_RECRUITING

    Wuhan, 430030, China

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • West China Hospital, Sichuan University

    NOT_YET_RECRUITING

    Chengdu, 610041, China

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