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
Professor Chan Cheah
Loxo Oncology, Inc
- Chronic Lymphocytic Leukemia
- Non-Hodgkin’s Lymphoma
- Small Lymphocytic Lymphoma
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:
- 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.
- 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.