Trial Outcomes & Findings for A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors (NCT NCT02836600)

Last Updated: 2025-08-07

Results Overview

DLT was defined as an adverse event (AE) that occurred during Cycle 1 (first 28 days) related to the study drug and met one of the following criteria per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. These criteria included: CTCAE Grade greater than or equal to (≥) 3 non-hematological toxicity, with exceptions for nausea, vomiting, or constipation, and asymptomatic electrolyte disturbances that can be controlled with standard treatment; Grade 4 hematological toxicity of greater than (\>) 5 days duration; Grade ≥ 3 anemia requiring transfusion; any febrile neutropenia; neutropenia needing granulocyte-colony stimulating factors (GCSFs); Grade 3 thrombocytopenia with bleeding or requiring platelet transfusion; Grade 4 thrombocytopenia.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

Cycle 1 (Up to 28 Days)

Results posted on

2025-08-07

Participant Flow

* This study was a dose-escalation trial that included separate groups of participants who received 25 milligrams (mg) or 50 mg of LY3039478, administered orally three times per week (TIW) in a 28-day cycle. * The dose was escalated from 25 mg to 50 mg only if the frequency of dose-limiting toxicity (DLT) in Cycle 1 (28 days) was less than 33 percent (\<33%) among participants who had received 25 mg LY3039478.

Participant milestones

Participant milestones
Measure	25 mg LY3039478 Participants received 25 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.	50 mg LY3039478 Participants received 50 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.
Overall Study STARTED	4	7
Overall Study Received at Least One Dose of LY3039478	4	7
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	25 mg LY3039478 n=4 Participants Participants received 25 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.	50 mg LY3039478 n=7 Participants Participants received 50 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.	Total n=11 Participants Total of all reporting groups
Age, Continuous	64.25 years STANDARD_DEVIATION 5.85 • n=5 Participants	66.71 years STANDARD_DEVIATION 15.10 • n=7 Participants	65.82 years STANDARD_DEVIATION 12.19 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Up to 28 Days)

Population: All participants with evaluable DLT data in Cycle 1 (the first 28 days) had received greater than or equal to (≥) 75% of the assigned dose during Cycle 1 or had experienced a DLT during Cycle 1.

Outcome measures

Outcome measures
Measure	25 mg LY3039478 n=4 Participants Participants received 25 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.	50 mg LY3039478 n=6 Participants Participants received 50 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.
Number of Participants With LY3039478 Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline through Measured Progressive Disease (Up To 100 Weeks)

Population: All enrolled participants who received at least one dose of LY3039478.

* The ORR was defined as the percentage of participants achieving either a CR or PR. Tumor response was assessed based on histology: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) was used for solid tumors, and Response Assessment in Neuro-Oncology criteria were used for glioblastoma. * CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to \<10 mm. Additionally, tumor marker results were required to have normalized. PR was defined as a decrease of at least 30% in the sum of the diameters of target lesions, using baseline diameters as the reference.

Outcome measures

Outcome measures
Measure	25 mg LY3039478 n=4 Participants Participants received 25 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.	50 mg LY3039478 n=7 Participants Participants received 50 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.
Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) PR	0 percentage of participants	0 percentage of participants
Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) CR	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Cycle 1, Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose); Cycle 1 Day 22 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose)

Population: All enrolled participants who received at least one dose of LY3039478 and had at least one evaluable PK data. Number analyzed refer to participants evaluable at specified time points.

PK: Cmax of LY3039478 was reported.

Outcome measures

Outcome measures
Measure	25 mg LY3039478 n=4 Participants Participants received 25 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.	50 mg LY3039478 n=7 Participants Participants received 50 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3039478 Cycle 1, Day 22	429 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 69	416 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 70
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3039478 Cycle 1, Day 1	324 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 34	670 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 39

SECONDARY outcome

Timeframe: Cycle 1, Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose); Cycle 1 Day 22 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post-dose)

Population: All enrolled participants who received at least one dose of LY3039478 and had at least one evaluable PK data. Number analyzed refer to participants evaluable at specified time points.

PK: AUC (0-24) of LY3039478 was reported.

Outcome measures

Outcome measures
Measure	25 mg LY3039478 n=4 Participants Participants received 25 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.	50 mg LY3039478 n=6 Participants Participants received 50 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.
PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3039478 Cycle 1, Day 1	1480 nanogramshours per milliliter(ngh/mL) Geometric Coefficient of Variation 20	3080 nanogramshours per milliliter(ngh/mL) Geometric Coefficient of Variation 38
PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3039478 Cycle 1, Day 22	2070 nanogramshours per milliliter(ngh/mL) Geometric Coefficient of Variation 54	2090 nanogramshours per milliliter(ngh/mL) Geometric Coefficient of Variation 76

Adverse Events

25 mg LY3039478

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

50 mg LY3039478

Serious events: 0 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	25 mg LY3039478 n=4 participants at risk Participants received 25 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.	50 mg LY3039478 n=7 participants at risk Participants received 50 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Cardiac disorders Supraventricular tachycardia	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Eye disorders Visual impairment	25.0% 1/4 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	0.00% 0/7 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	0.00% 0/7 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	42.9% 3/7 • Number of events 4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Gastrointestinal disorders Nausea	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	42.9% 3/7 • Number of events 4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 2 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
General disorders Fatigue	25.0% 1/4 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	0.00% 0/7 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
General disorders Influenza like illness	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
General disorders Malaise	25.0% 1/4 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
General disorders Pyrexia	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Infections and infestations Cystitis	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Infections and infestations Lung infection	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Infections and infestations Pneumonia	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Infections and infestations Tinea pedis	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Infections and infestations Urinary tract infection	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Investigations Alanine aminotransferase increased	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Investigations Hepatic enzyme increased	50.0% 2/4 • Number of events 2 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Investigations Lipase increased	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Investigations Neutrophil count decreased	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 2 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Investigations White blood cell count decreased	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	42.9% 3/7 • Number of events 3 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	28.6% 2/7 • Number of events 2 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	50.0% 2/4 • Number of events 2 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	0.00% 0/7 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Nervous system disorders Dizziness	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Nervous system disorders Hemiplegia	25.0% 1/4 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	0.00% 0/7 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Psychiatric disorders Delirium	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	0.00% 0/7 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Skin and subcutaneous tissue disorders Dry skin	25.0% 1/4 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Skin and subcutaneous tissue disorders Hair colour changes	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	14.3% 1/7 • Number of events 1 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.	42.9% 3/7 • Number of events 3 • Baseline to end of the follow-up (Up To 100 Weeks) All enrolled participants who received at least one dose of LY3039478.