Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New Antibody-Drug conjugate targets Hard-to-Treat cancers

NCT ID NCT06465069

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 11 times

Summary

This early-stage trial tests a new drug called LY4052031, which is designed to deliver a cancer-killing agent directly to tumor cells that have a protein called Nectin-4. The study includes 420 adults with advanced or metastatic solid tumors such as bladder, breast, lung, and others. The goal is to find a safe dose and see if 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
LY4052031 (an antibody-drug conjugate targeting Nectin-4)
What this could lead to
If successful, this could lead to a new treatment option for several advanced cancers that are hard to treat.
What could go wrong
This is an early Phase 1 trial, so the drug may not be effective or could have serious side effects. It will take years to know if it works.

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 420 people

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

Started

Jul 2024

Expected to finish

May 2027

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 solid tumor cancers: * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer * Cohort A2/B1/B2: urothelial carcinoma * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer * Prior Systemic Therapy Criteria: * Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies * Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies. * Prior enfortumab vedotin specific requirements: * Cohorts A1/A2/C: prior treatment with enfortumab vedotin is allowed, but not required * Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting * Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting. * Measurability of disease * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1) * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1 * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations Exclusion Criteria: * Individual with known or suspected uncontrolled CNS metastases * Individual with uncontrolled hypercalcemia * Individual with uncontrolled diabetes * Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant * Any serious unresolved toxicities from prior therapy * Significant cardiovascular disease * Recent thromboembolic event and/or clinically significant bleeding disorder * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms * History of pneumonitis/interstitial lung disease * History of Grade ≥3 skin toxicity when receiving enfortumab vedotin * Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm cervical cancer esophageal cancer Esophageal Neoplasms head and neck squamous cell carcinoma malignant pancreatic neoplasm metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma ovarian cancer pancreatic neoplasm prostate cancer renal pelvis carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma ureter cancer urinary bladder carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms urothelial carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

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

Advanced solid tumor Bladder cancer Cervical cancer Esophageal cancer Head and neck squamous cell carcinoma Metastatic solid tumor Non-small cell lung cancer Ovarian cancer Pancreatic cancer Prostate cancer Recurrent solid tumor Renal pelvis cancer Triple-negative breast cancer Urinary bladder neoplasm

How to take part

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

  1. The places running it

    38 sites in 8 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

  • Aichi Cancer Center Hospital

    RECRUITING

    Nagoya, 464-8681, Japan

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Beijing Cancer hospital

    RECRUITING

    Beijing, 100142, China

  • Catalan Institute of Oncology Duran i Reynals Hospital

    RECRUITING

    Barcelona, 8908, Spain

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010-0269, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032-3729, United States

  • Florida Cancer Specialists and Research Institute

    COMPLETED

    St. Petersburg, Florida, 33705, United States

  • Hospital Madrid Norte Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • IU Simon Cancer Center

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029-6574, United States

  • Institut Gustave Roussy (Igr)

    RECRUITING

    Villejuif, 94805, France

  • Linear Clinical Research

    RECRUITING

    Nedlands, 6009, Australia

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)

    RECRUITING

    New York, New York, 10016, United States

  • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • National Cancer Center Hospital

    RECRUITING

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, 200000, China

  • START Midwest Cancer and Hematology Centers of W Michigan

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at HealthOne

    RECRUITING

    Denver, Colorado, 80218, United States

  • South Texas Accelerated Research Therapeutics (START)

    RECRUITING

    San Antonio, Texas, 78229, United States

  • St Bartholomew's Hospital

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • St Vincent's Hospital

    RECRUITING

    Darlinghurst, 2010, Australia

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, 510060, China

  • Tennessee Oncology PLLC

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Kōtō City, 135-8550, Japan

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • UCLA Department of Medicine-Hematology/Oncology

    RECRUITING

    Los Angeles, California, 90024, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California, San Diego (UCSD) - Moores Cancer Center

    NOT_YET_RECRUITING

    La Jolla, California, 92093, United States

  • University of Chicago Hospital

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4000, United States

  • University of Utah - Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Washington University School of Medicine in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.