This is an open-label, multi-center Phase 1/2 study of oral LOXO-305 in patients with Chronic lymphocytic leukemia, Small Lymphocytic Lymphoma and Non-Hodgkin lymphoma who have failed or are intolerant to standard of care treatment



This study is for patients with Chronic lymphocytic leukemia (CLL), Small Lymphocytic Lymphoma (SLL) and Non-Hodgkin lymphoma (NHL) who have failed or are intolerant to standard of care treatment.

The study includes 2 parts:
Phase 1 is a dose escalation, where the maximum tolerated dose of LOXO-305 will be evaluated
Phase 2 is a dose expansion, where patients will receive the established recommended dose of LOXO-305


Include, but not limited to, the following:

Inclusion Criteria:
1. Histologically confirmed CLL/SLL or NHL intolerant to standard of care therapies.
2. Histologically confirmed CLL/SLL or NHL which has failed standard of care therapies
3. ≥ 2 prior lines of therapy.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) 0-2.
6. Adequate hematologic, hepatic and renal function.
7. Ability to receive study drug therapy orally.
8. Willingness of men and women of reproductive potential to observe conventional and effective birth control.

Exclusion Criteria:
1. Transformation (e.g., Richter's transformation, prolymphocytic leukemia, transformed NHL, blastoid lymphoma) prior to planned start of LOXO-305.
2. Investigational agent or anticancer therapy within 2 weeks prior to planned start of LOXO-305. In addition, no concurrent investigational therapy is permitted.
4. Major surgery within 4 weeks prior to planned start of LOXO-305.
6. Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment.
7. Pregnancy or lactation.
8. Patients requiring therapeutic anticoagulation.
9. 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.
10. 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).
11. Known central nervous system (CNS) involvement by lymphoma.
12. Active uncontrolled auto-immune cytopenia.
13. Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-305.
14. Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
15. Tested positive for Human Immunodeficiency Virus (HIV) is excluded.
16. Clinically significant active malabsorption syndrome.
17. Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitors
18. Treatment with proton pump inhibitors (PPIs) within 7 days of starting LOXO-305.
19. Active second malignancy unless in remission and with life expectancy > 2 years.

Contact person:

Lewis Edwards
Email cancertrialshaem1@linear.org.au
Phone +61 8 9386 5125


Principal Investigator:

A/Prof Chan Cheah

+61 8 6457 7600


Loxo Oncology



Protocol Number:


Trial Registration Number:


Clinical Trials.gov

ANZ Clinical Trial Registry