Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 1  | ENROLLING

NCT03770494

Advanced Solid Tumors

CDK7 Inhibitor


A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors*

NCT03770494
Key Inclusion Criteria
Phase 1a:
  • Advanced and/or metastatic cancer (solid tumors)
  • Available archived tissue for exploratory biomarker analysis
  • Adequate organ function
  • Discontinued all previous treatments for cancer and recovered from their side effects
  • Able to swallow capsules/tablets
Phase 1b:
  • Cohort 1: Triple-negative breast cancer (TNBC)
  • Cohort 2: Clear cell ovarian cancer, endometrioid ovarian cancer, or endometrioid endometrial carcinoma with an LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX)
  • Cohort 3: Soft tissue sarcoma or sarcomatoid/rhabdoid malignancy with loss of expression of INI1, BRG1, or BRM by immunohistochemistry, or an LOF mutation in one or more of the following genes: ARID1A, SMARCA2, SMARCA4, or SMARCB1. Participants aged ≥12 years with a body weight of ≥40 kg, with synovial sarcoma and a confirmed SS18-SSX gene fusion, are eligible
  • Cohort 4: Epithelioid sarcoma with INI1 loss of expression by immunohistochemistry or SMARCB1 LOF mutation. Participants aged ≥12 years with a body weight of ≥40 kg are acceptable
  • Cohort 5: Bladder cancer with an LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX)
Key Exclusion Criteria
  • Unstable cancer of the central nervous system
  • Symptomatic infections such as HIV or hepatitis A, B, or C
  • Congestive heart failure
  • Breastfeeding
*
This clinical trial is being conducted globally.
LY3405105 is administered PO. 
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.