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New cancer drug shows promise in early trial

NCT ID NCT01695005

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 1 study tested an experimental drug called LY3039478 in 247 people with advanced or metastatic cancer, including lymphoma. The main goal was to find a safe dose and see how the drug affects the body. Researchers also looked for signs that the drug might 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
LY3039478 (an experimental drug taken by mouth, sometimes with prednisone)
What this could lead to
If it works, this could point toward a treatment option for advanced or metastatic cancers that have not responded to standard therapies.
What could go wrong
This is an early phase 1 trial, so the main goal is safety and dosing, not effectiveness. Many drugs fail at this stage, and side effects like heart problems or other toxicities may occur.

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

247 people

The number who actually took part.

Start date

Oct 2012

Finished

Jun 2018

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: * For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer. * For Dose Escalation (Part A): The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic. * For Part B: All participants must have a histological evidence of their advanced or metastatic cancer and prescreened alterations in a defined pathway. * For Part C: All participants must have histological evidence of advanced or metastatic specific subtypes of soft tissue sarcoma. * For Part D: All participants must have histological evidence of advanced or metastatic cancer and prescreened alterations in a defined pathway. * Cohort 1: Participants must have triple negative breast cancer. * Cohort 2: Participants must have hepatocellular carcinoma (HCC). These participants should have Child-Pugh stage A. * Cohort 3: Participants must have cholangiocarcinoma. * Cohort 4: Participants must have chronic lymphocytic leukemia. * Cohort 5: Participants must have a mature T cell, B cell, or natural killer (NK) cell neoplasm. * For Part E: Participants must have adenoid cystic carcinoma (ACC). * For Part F dose confirmation: Participants must have leiomyosarcoma and prescreened alterations in a defined pathway. * As defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the Revised Response Criteria for Malignant Lymphoma or the Response Assessment in Neuro Oncology (RANO) criteria for glioblastoma: * For Dose Escalation (Part A): Have measurable or nonmeasurable disease. * For Parts B, C, D, E and F: Have measurable disease or reliable biomarker measure. * For Parts B, C, D, E and F: Have available tumor tissue. * Have adequate organ function. * Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale and life expectancy of more than 12 weeks. Exclusion Criteria: * Have symptomatic or non stable central nervous system (CNS) malignancy. * Females who are pregnant or lactating. * Have active bacterial, fungal, and/or known viral infection. * Have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or diarrhea (acute or chronic). * Participants with HCC that: * Have known HCC with fibro-lamellar or mixed histology. * Have presence of clinically relevant ascites. * Have had a liver transplant. * Have active or uncontrolled clinically serious hepatitis B virus or hepatitis C virus infection.

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Conditions

The condition(s) this trial relates to.

adenoid cystic carcinoma B-cell chronic lymphocytic leukemia cholangiocarcinoma hepatocellular carcinoma leiomyosarcoma lymphoma metastatic malignant neoplasm metastatic neoplasm neoplasm Neoplasm Metastasis neoplasm of mature T-cells or NK-cells soft tissue sarcoma triple-negative breast carcinoma

As listed by the trial registrant

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

Lymphoma Neoplasm metastasis Neoplasms

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Copenhagen, 2100, Denmark

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Paris, 75248, France

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Villejuif, 94805, France

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Tübingen, 72076, Germany

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Barcelona, 08035, Spain

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    London, SE1 9RT, United Kingdom

  • Harvard Medical School

    Boston, Massachusetts, 02215, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • University of Miami School of Medicine

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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