Clinical trial · Interventional
A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors
A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors
NCT03343613CI-TRIAL-00045446terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to strategic business decision by Eli Lilly and Company.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY3300054 | Drug | — | UNRESOLVED |
| LY3381916 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- LY3381916 Escalation
- description
- LY3381916 administered orally.
- interventionNames
- Drug: LY3381916
- type
- EXPERIMENTAL
- label
- LY3381916 + LY3300054 Escalation
- description
- LY3381916 administered orally and LY3300054 administered intravenously (IV).
- interventionNames
- Drug: LY3381916
- Drug: LY3300054
- type
- EXPERIMENTAL
- label
- LY3381916 Expansion
- description
- LY3381916 administered orally.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Dose escalation phase: Participant must have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic. * Dose expansion B1: Metastatic TNBC participants who have not received prior PD-1/L1 treatment. * Dose expansion B2: Metastatic NSCLC participants who have progressed on prior PD-L1/L1 treatment. * Dose expansion B3: Metastatic clear cell carcinoma RCC who have progressed on prior PD-L1/L1 treatment. * Have adequate organ function. * Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Are able and willing to provide required, newly acquired tumor biopsies. * Have discontinued previous treatments for cancer. * Are able to swallow capsules. Exclusion Criteria: * Currently enrolled in a clinical study. * Have known symptomatic central nervous system metastases or carcinomatous meningitis. * Have a serious concomitant systemic disorder. * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C. * Have a significant cardiac condition. * Have previously received an indoleamine- 2,3-dioxygenase (IDO) inhibitor. * Have an active autoimmune disease or currently require immunosuppression of \>10 milligrams of prednisone or equivalent per day. * Have interstitial lung disease or (noninfectious) pneumonitis, participants with a history of (noninfectious) pneumonitis that required steroids to assist with management.
References
Publications (0)
Data not yet available
No reference posted for this study.