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Experimental cancer drug LY3405105 fails to advance in early trial

NCT ID NCT03770494

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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-phase study tested the safety of an oral drug called LY3405105 in 54 people with advanced solid tumors. The trial was divided into two parts to find the right dose and to see if the drug could shrink tumors. However, the study was terminated early, meaning the drug did not show enough promise or had too many side effects to continue.

What this could mean

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

Active substance
LY3405105 (oral drug)
What this could lead to
If it works, this could point toward a treatment for advanced solid tumors.
What could go wrong
This was an early phase 1 trial with only 54 participants, and it was terminated early. The drug may not be effective or safe enough to continue development.

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

54 people

The number who actually took part.

Started

Jan 2019

Finished

Feb 2021

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: Phase 1 a: * Have histological or cytological evidence of a diagnosis of a solid tumor cancer that is advanced and/or metastatic * Have available archived tissue for exploratory biomarker analysis * Have adequate organ function * Have discontinued all previous treatments for cancer and recovered from their side effects * Are able to swallow capsules/tablets Phase 1 b: * Cohort 1: Triple-negative breast cancer (TNBC). * Cohort 2: Clear cell ovarian cancer, endometrioid ovarian cancer, or endometrioid endometrial carcinoma with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX). * Cohort 3: Soft tissue sarcoma or sarcomatoid/rhabdoid malignancy with loss of expression of INI1, BRG1, or BRM by immunohistochemistry or a LOF mutation in one or more of the following genes: ARID1A, SMARCA2, SMARCA4, or SMARCB1. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 3. Participants with synovial sarcoma and a confirmed SS18-SSX gene fusion are also eligible. * Cohort 4: Epithelioid sarcoma with INI1 loss of expression by immunohistochemistry or SMARCB1 LOF mutation. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 4. * Cohort 5: Bladder cancer with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX). Exclusion Criteria: * Have symptomatic central nervous system (CNS) malignancy or metastasis * Have symptomatic human immunodeficiency virus (HIV), Hepatitis A, B, or C * Have congestive heart failure * Are breastfeeding

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Conditions

The condition(s) this trial relates to.

endometrial endometrioid adenocarcinoma epithelioid sarcoma neoplasm ovarian clear cell tumor ovarian endometrioid adenocarcinoma soft tissue sarcoma synovial sarcoma triple-negative breast carcinoma urinary bladder carcinoma

As listed by the trial registrant

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

Solid tumor

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Gustave Roussy

    Villejuif, 94805, France

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703, United States

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Curie

    Paris, 75248, France

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • Princess Margaret Hospital

    Toronto, Ontario, M5TY 2M9, Canada

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06511, United States

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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