A Phase 1/2 Study of Oral LOXO-305 in CLL/SLL or NHL relapsed Patients
Research type
Research Study
Full 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)
IRAS ID
264817
Contact name
Toby Eyre
Contact email
Sponsor organisation
Loxo Oncology, Inc
Eudract number
2018-003340-24
Clinicaltrials.gov Identifier
139876, IND#
Duration of Study in the UK
2 years, 0 months, 17 days
Research summary
This is an open-label, multi-centre, Phase 1/2 study of oral LOXO-305 in patients with Cancer, specifically Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) - who have failed or are intolerant to standard of care.
This research study is being done to test the safety of an experimental (investigational) treatment called LOXO-305. LOXO-305 is an investigational drug that may treat certain cancers like leukemias and lymphomas.
These cancers are dependent on or “addicted to” a protein made by the cancers called “BTK”. LOXO-305 is a “BTK inhibitor”—it is designed to block both normal and mutated forms of BTK in these cancers, including cancers against which available BTK inhibitors (e.g. ibrutinib, acalabrutinib) have stopped working.
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 was 25 mg/day (e.g., 25 mg once daily [QD]). Once the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) is identified, patients will be enrolled to Phase 2.
Phase 2 patients will be enrolled into one of six phase 2 dose expansion cohorts depending on tumour histology, tumour genotype, and prior treatment history. Cycle length will be 28 days. Phase 2 aims to assess the preliminary anti-tumor activity of LOXO-305 based on overall response rate (ORR) as assessed by an Independent Review Committee (IRC).
The study will take place at NHS sites in the UK.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0295
Date of REC Opinion
20 Dec 2019
REC opinion
Further Information Favourable Opinion