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New cancer drug shows promise in early trial

NCT ID NCT06238479

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called LY4101174 in people with advanced solid tumors, including bladder, breast, and lung cancers. The drug is an antibody-drug conjugate designed to target and kill cancer cells. The study will check if the drug is safe, tolerable, and effective, and will involve about 490 participants over up to 4 years.

What this could mean

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

Active substance
LY4101174 (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 have stopped responding to other therapies.
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 is still being tested for the right dose and safety.

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 490 people

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

Started

Mar 2024

Expected to finish

Apr 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 C1: triple negative breast cancer * Cohort C2: non-small cell lung cancer * Cohort C3: ovarian or fallopian tube cancer * Cohort C4: cervical cancer * Cohort C5: head and neck squamous cell carcinoma * Prior Systemic Therapy Criteria: * Cohort A1/C1-5: 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/C1-5: 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) * Cohorts A2, B1, B2, C1-5: measurable disease required 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 history of corneal transplant * Any serious unresolved toxicities from prior therapy * Significant cardiovascular disease * Current of history of intestinal obstruction in the previous 3 months * Recent thromboembolic event and/or clinically significant bleeding * 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 * Individual with active uncontrolled infection

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm cervical cancer esophageal cancer Esophageal Neoplasms fallopian tube cancer 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

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32804, United States

  • Austin Health

    Heidelberg, 3084, Australia

  • CHU Strasbourg-Hautepierre

    Strasbourg, 67098, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Gustave Roussy

    Villejuif, 94805, France

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hunan Cancer Hospital

    Changsha, 410013, China

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, 5037, Australia

  • Institut Jules Bordet

    Anderlecht, 1070, Belgium

  • Institut Paoli-Calmettes

    Marseille, 13273, France

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cancer Center Hospital

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, 277-8577, Japan

  • Peking University First Hospital

    Beijing, 100034, China

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • Shanghai East Hospital

    Shanghai, 200433, China

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 78229-3307, United States

  • The Cancer Institute Hospital of JFCR

    Kōtō City, 135-8550, Japan

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-8884, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

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