Clinical trial · Interventional
A Study of AK-01 (LY3295668) in Solid Tumors
A Phase I/II Open-Label Multicenter Study to Evaluate the Safety and Efficacy of AK-01 as Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
NCT03092934CI-TRIAL-00052536completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This two-part study consists of a phase 1 dose escalation study in participants with locally advanced or metastatic solid tumors, and a phase 2 portion in up to 3 groups with either small cell lung cancer, breast cancer and/or one other solid tumor type.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
| Triple Negative Breast Neoplasms | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY3295668 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 25 milligrams (mg) LY3295668 (Phase 1)
- description
- 25 milligrams (mg) LY3295668 twice daily (BID) administered orally in 21-day cycles.
- interventionNames
- Drug: LY3295668
- type
- EXPERIMENTAL
- label
- 50 mg LY3295668 (Phase 1)
- description
- 50 mg LY3295668 BID administered orally in 21-day cycles.
- interventionNames
- Drug: LY3295668
- type
- EXPERIMENTAL
- label
- 75 mg LY3295668 (Phase 1)
- description
- 75 mg LY3295668 BID administered orally in 21-day cycles.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have received at least 1 but no more than 4 prior systemic therapies * Have adequate organ function * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale * Have estimated life expectancy greater than or equal to (≥)12 weeks * Have fully recovered from radiation therapy or surgery, and are recovering from any acute adverse effects of other cancer therapies * Have discontinued all chemotherapy, investigational therapy, molecularly-targeted therapy, and cancer-related hormonal therapy at least 14 days prior, biologic or immunotherapeutic therapy at least 21 days prior, or mitomycin-C or nitrosoureas at least 6 weeks prior * Female participants with reproductive potential agree to use 2 forms of highly effective contraception during the study and for the following 3 months * Male participants must use a barrier method of contraception during the study and for the following 3 months Phase 1 * Have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor) Phase 2 * Have disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 * Have evidence of a solid tumor that is locally advanced and/or metastatic, and in: * Small Cell Lung Cancer (SCLC), must have failed platinum-containing therapy * Breast Cancer, be Estrogen Receptor positive and/or Progesterone Receptor positive, but Human Epidermal Growth Factor Receptor 2 (HER2) negative, and must have failed a hormone therapy and a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor * Triple negative breast cancer (TNBC) and failed standard therapy * Squamous cell cancers of the head neck associated with the human papilloma virus (HPV), and have failed standard therapy * Other solid tumor type that has been approved by the sponsor Exclusion Criteria: * Have symptomatic central nervous system (CNS) metastasis (unless asymptomatic and not current receiving corticosteroids) or a primary tumor of the CNS * Have a medical condition that precludes participation (swallowing disorder, organ transplant, pregnant or nursing, HIV, active Hepatitis B or C, cardiac disease, history of major surgery in upper gastrointestinal (GI) tract or GI disease, hypokalemia, hypomagnesaemia or hypocalcaemia that cannot be controlled)
References
Publications (1)
- DERIVEDChu QS, Bouganim N, Fortier C, Zaknoen S, Stille JR, Kremer JD, Yuen E, Hui YH, de la Pena A, Lithio A, Smith PS, Batist G. Aurora kinase A inhibitor, LY3295668 erbumine: a phase 1 monotherapy safety study in patients with locally advanced or metastatic solid tumors. Invest New Drugs. 2021 Aug;39(4):1001-1010. doi: 10.1007/s10637-020-01049-3. Epub 2021 Jan 22. PMID 33479856