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 2  | ENROLLING

BRUIN; NCT03740529

CLL/SLL or NHL

BTK Inhibitor


A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin's Lymphoma (NHL)*

NCT03740529
Key Inclusion Criteria
  • Phase 1/2 LOXO-305 monotherapy: B-cell malignancies that have failed or are intolerant to either ≥2 prior standard-of-care regimens given in combination or sequentially, or received one prior BTK inhibitor (BTKi) regimen when a BTKi is approved as first-line therapy (phase 1) OR with prior treatment defined by phase 2 cohort (phase 2 patients only)
  • Phase 1b arm A: Relapsed/refractory (R/R) CLL and venetoclax is appropriate salvage treatment
  • Phase 1b arm B: R/R CLL and venetoclax + rituximab is appropriate salvage treatment
  • At least 18 years of age
  • Phase 1/1b: Adequate hematologic function that is responsive to transfusion support for thrombocytopenia or anemia
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate hepatic and renal function
  • Able to receive oral study drug
  • Willing to use conventional and effective birth control
Key Exclusion Criteria
  • Concurrent investigational agent or anticancer therapy within 5 half-lives prior to planned start of specified study treatment; therapeutic monoclonal antibody treatment must be discontinued ≥4 weeks prior to the first dose of study treatment; no concurrent systemic anticancer investigational therapy is permitted
  • Major surgery within 4 weeks prior to planned study treatment
  • Radiotherapy with a limited field of radiation for palliation within 7 days of study treatment
  • Pregnant or breastfeeding
  • Require therapeutic anticoagulation with warfarin
  • Any unresolved ≥ grade 2 toxicities as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 attributed to prior therapy (other than alopecia) at the start of study treatment
  • History of allogeneic or autologous stem-cell transplant or chimeric antigen receptor-modified T-cell therapy within the past 60 days (180 days before the PK trigger) prior to planned start of specified study treatment
  • Known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of disease may be eligible and enrolled to phase 2 cohort 7 if a compelling clinical rationale is provided by the investigator and with documented sponsor approval
  • Active uncontrolled autoimmune cytopenia when new or concomitant therapy was introduced or escalated to maintain adequate blood counts within 4 weeks prior to study enrollment
  • Uncontrolled cardiac or cardiovascular disease, or myocardial infarction within 6 months prior to planned start of study treatment
  • HIV or active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Active malabsorption syndrome
  • Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
  • Treatment with proton pump inhibitors within 7 days of starting study treatment
  • Phase 1b arm A or B: Patients with prior treatment with venetoclax or other BCL-2 inhibitors
  • Active second malignancy unless in remission and with life expectancy >2 years
  • Phase 1 arm B: Prior significant hypersensitivity to rituximab/biosimilar requiring discontinuation, or prior allergic or anaphylactic reaction to rituximab
*
This clinical trial is being conducted globally.
LOXO-305 is administered PO.
Venetoclax is administered PO.
§
Rituximab is administered intravenously.
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.