A Study of LY3039478 in Participants With Advanced Cancer

Completed · Phase 1

Conditions studied: Neoplasms, Neoplasm Metastasis, Lymphoma

In brief

The purpose of this study is to find a recommended dose level of LY3039478 that can safely be taken by participants with advanced cancer or cancer that has spread to other parts of the body, including but not limited to lymphoma. The study will also explore changes to various markers in blood cells and tissue. Finally, the study will help to document any tumor activity this drug may have.

Key facts

Study ID: NCT01695005
Run by: Eli Lilly and Company
People needed: 247
Starts: 2012-10-01
Expected to finish: 2018-06-26
Last updated by the study team: 2025-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Miami School of Medicine — Miami, Florida, United States
Harvard Medical School — Boston, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Columbia University Medical Center — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, 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, 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, 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, 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, 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, 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, United Kingdom

Full record on ClinicalTrials.gov

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