Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
With
AurKa Pharma Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
