A Study of AK-01 (LY3295668) in Solid Tumors

Lilly

Status and phase: Completed; Phase 2; Phase 1

Conditions: Solid Tumor, Adult; Neoplasms; Triple Negative Breast Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Head and Neck Neoplasms; Small Cell Lung Carcinoma

Treatments: Drug: LY3295668

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03092934

17228

AURA-001 (Other Identifier)

J1O-MC-JZHA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 4 patient groups

25 milligrams (mg) LY3295668 (Phase 1)

Experimental group

Description:

25 milligrams (mg) LY3295668 twice daily (BID) administered orally in 21-day cycles.

Treatment:

Drug: LY3295668

50 mg LY3295668 (Phase 1)

Experimental group

Description:

50 mg LY3295668 BID administered orally in 21-day cycles.

Treatment:

Drug: LY3295668

75 mg LY3295668 (Phase 1)

Experimental group

Description:

75 mg LY3295668 BID administered orally in 21-day cycles.

Treatment:

Drug: LY3295668

25 mg LY3295668 (Phase 2)

Experimental group

Description:

25 mg LY3295668 BID administered orally in 21-day cycles.

Treatment:

Drug: LY3295668