for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Bita Fakhri



This is an open-label, multi-center Phase 1/2 study of oral LOXO-305 in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

Official Title

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 Lymphoma (NHL)


This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, patients will be enrolled using an accelerated titration design. The starting dose of LOXO-305 in oral tablet form is 25 mg/day (e.g., 25 mg once daily [QD]). Once the MTD and/or RP2D is identified, patients will be enrolled to one of six phase 2 dose expansion cohorts depending on tumor histology, tumor genotype, and prior treatment history. Cycle length will be 28 days.


Chronic Lymphocytic Leukemia Waldenstrom Macroglobulinemia Mantle Cell Lymphoma Marginal Zone Lymphoma B-cell Lymphoma Small Lymphocytic Lymphoma Loxo LOXO-305 BTK Bruton's tyrosine kinase CLL SLL NHL C481S C481 Ibrutinib Acalabrutinib Zanubrutinib BGB-3111 GS-4059 ONO-4059 Tirabrutinib Non-Hodgkin Lymphoma BTK Intolerant C481S Mutation DLBCL (Diffuse Large B-cell lymphoma) Follicular Lymphoma Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, B-Cell Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone CLL/SLL/WM/MCL/MZL/other NHL intolerant to prior BTKi Other


You can join if…

Open to people ages 18 years and up

  • Histologically confirmed CLL/SLL or NHL intolerant to standard of care therapies.
  • Histologically confirmed CLL/SLL or NHL which has failed standard of care therapies
  • ≥ 2 prior lines of therapy.
  • For initial phase 1 patients, able to tolerate potentially subtherapeutic doses of LOXO-305 for the 28-day DLT window in the opinion of the investigator and with documented sponsor approval.
  • Eastern Cooperative Oncology Group (ECOG) 0-2.
  • Adequate hematologic, hepatic and renal function.
  • Ability to receive study drug therapy orally.
  • Willingness of men and women of reproductive potential to observe conventional and effective birth control.

You CAN'T join if...

  • Transformation (e.g., Richter's transformation, prolymphocytic leukemia, transformed NHL, blastoid lymphoma) prior to planned start of LOXO-305.
  • Investigational agent or anticancer therapy within 2 weeks prior to planned start of LOXO-305. In addition, no concurrent investigational therapy is permitted.
  • Major surgery within 4 weeks prior to planned start of LOXO-305.
  • Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment.
  • Pregnancy or lactation.
  • Patients requiring therapeutic anticoagulation.
  • Any unresolved toxicities from prior therapy greater than CTCAE (version 5.0) Grade 2 or greater at the time of starting study treatment except for alopecia.
  • History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 100 days (180 days before the PK trigger).
  • Known central nervous system (CNS) involvement by lymphoma.
  • Active uncontrolled auto-immune cytopenia.
  • Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-305.
  • Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
  • Tested positive for Human Immunodeficiency Virus (HIV) is excluded.
  • Clinically significant active malabsorption syndrome.
  • Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitors
  • Treatment with proton pump inhibitors (PPIs) within 7 days of starting LOXO-305.

Active second malignancy unless in remission and with life expectancy > 2 years.


  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Swedish Cancer Institute accepting new patients
    Seattle Washington 98104 United States

Lead Scientist

  • Bita Fakhri
    Assistant Professor, Medicine. Authored (or co-authored) 12 research publications


accepting new patients
Start Date
Completion Date
Loxo Oncology, Inc.
Phase 1/2
Study Type
Last Updated