Phase 1
Completed N=11
A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors
Advanced Solid Tumor
Source: ClinicalTrials.gov NCT02836600 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Number of Participants With LY3039478 Dose-Limiting Toxicities (DLTs) — 0; 0 Participants
Summary
The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With LY3039478 Dose-Limiting Toxicities (DLTs) |
0; 0 | — |
| SECONDARY Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) |
0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3039478 |
324; 670; 429; 416 | — |
| SECONDARY PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3039478 |
1480; 3080; 2070; 2090 | — |
Eligibility Criteria
Inclusion Criteria
- Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic.
- In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate.
- Performance status of less than or equal to (≤) 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Adequate organ function, including hematologic, hepatic, and renal.
- Estimated life expectancy of greater than or equal to (≥) 12 weeks.
Exclusion Criteria
- Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively.
- Have serious preexisting medical conditions.
- Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea.
- Have an active bacterial, fungal, and/or known viral infection.
- Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results.
Data sourced from ClinicalTrials.gov (NCT02836600). 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. Informational only — not medical advice.