Phase 1 N=247 Treatment

A Study of LY3039478 in Participants With Advanced Cancer

Neoplasms · Neoplasm Metastasis · Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT01695005 ↗

Enrolled (actual)

247

Serious AEs

49.4%

Results posted

Dec 2025

Primary outcome: Primary: Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 0; 0; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: LY3039478 (Drug); Prednisone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Part A and F: Number of Participants With Dose Limiting Toxicities (DLTs)	0; 0; 0; 1; 1; 0	—
PRIMARY Part A: Recommended Phase 2 Dose of LY3039478 : Maximum Tolerated Dose (MTD)	75	—
PRIMARY Part B, C, D and E: Recommended Phase 2 Dose of LY3039478 : Maximum Tolerated Dose (MTD)	50	—
PRIMARY Part F1 and F2: Recommended Phase 2 Dose of LY3039478	NA	—
PRIMARY Part B, C, D, E and F: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	0; 0; 0; 0; 0; 0	—
SECONDARY Parts A, B, C, D and E: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478	13.5; 36.0; 63.1; 220; 288; 264	—
SECONDARY Part F1 Cohort1 and Part F2 Cohort 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3039478	1450; 1030; NA; 765	—
SECONDARY Parts A and B: PK: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478	98.4; 282; 412; 1410; 1590; 1250	—
SECONDARY Part F1 Cohort1 and Part F2 Cohort 1: PK: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478	5440; 4410	—
SECONDARY Parts A and B: PK: Area Under the Concentration-Time Curve From Time 0 to Tau (AUC[0-Tau]) of LY3039478	NA; 290; 585; 1170; 1290; 3220	—
SECONDARY Part F1 Cohort1 and Part F2 Cohort 1: PK: Area Under the Concentration-Time Curve From Time 0 to Tau (AUC[0-Tau]) of LY3039478	NA; 3430	—
SECONDARY Parts A, B, C, D and E: PK: Time to Maximum Concentration (Tmax) of LY3039478	1.52; 2.00; 1.50; 1.87; 2.00; 1.03	—
SECONDARY Part F1 Cohort1 and Part F2 Cohort 1: PK: Time to Maximum Concentration (Tmax) of LY3039478	1.02; 1.03; NA; 2.00	—
SECONDARY Part A: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	0; 0; 0; 0; 0; 0	—
SECONDARY Part B, C, D, E and F: Duration of Response (DoR)	4.7	—
SECONDARY Part B, C, D, E and F: Progression Free Survival (PFS)	1.77; 1.84; 1.76; 3.61; 1.66; 1.68	—
SECONDARY Part B, C, D, E and F: Overall Survival (OS)	7.29; 8.94; 9.46; 12.80; 6.21; 2.20	—

Summary

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01695005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.