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

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.

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)