A Study of LY3039478 in Participants With Advanced Cancer
Neoplasms, Neoplasm Metastasis, Lymphoma
About this trial
This is an interventional treatment trial for Neoplasms
Eligibility Criteria
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.
Sites / Locations
- University of Miami School of Medicine
- Harvard Medical School
- University of Michigan
- Montefiore Medical Center
- Columbia University Medical Center
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
LY3039478 - Dose Escalation
LY3039478 - Cohort Expansion
Dose 1 LY3039478 + Prednisone
Dose 2 LY3039478 + Prednisone
Part A: LY3039478 administered orally three times per week (TIW) at escalating doses (2.5 milligrams [mg] to 100 mg) for two 28 day cycles. Participants receiving benefit may continue until disease progression
Part B, C, D and E: LY3039478 administered orally three times per week (TIW) at a fixed dose determined in Part A for two 28 day cycles. Participants receiving benefit may continue until disease progression.
Part F1: LY3039478 administered orally TIW for 28 day cycles. Prednisone will be co-administered with LY3039478 for the first 2 weeks in cycle 1 only (28 day cycles). Participants receiving benefit may continue until disease progression.
Part F2: LY3039478 administered orally TIW (twice a week in cycle 1) for 28 day cycles. Prednisone will be co-administered with LY3039478 for the first 2 weeks in cycle 1 only. Participants receiving benefit may continue until disease progression.