NCT03740529

A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 803 (actual)
• Sponsor: Loxo Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study includes 3 parts: Phase 1 (pirtobrutinib monotherapy dose escalation and dose expansion), Phase 1b (pirtobrutinib combination therapy dose expansion), and Phase 2 (pirtobrutinib monotherapy dose expansion). In Phase 1, patients will be enrolled using an accelerated titration design. The starting dose of pirtobrutinib in oral tablet form is 25 mg/day (e.g., 25 mg once daily \[QD\]). Once the MTD and/or RP2D is identified in Phase 1 dose escalation, enrollment will continue to Phase 1 dose expansion and can commence to Phase 1b (Arms A and B). For Phase 2, patients will be enrolled to one of seven Phase 2 dose expansion cohorts depending on tumor histology and prior treatment history. Cycle length will be 28 days.

Conditions

• Chronic Lymphocytic Leukemia
• Waldenstrom Macroglobulinemia
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma
• B-cell Lymphoma
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Oral
DRUG	Venetoclax	Oral
DRUG	Rituximab	IV

Timeline

• Start date: 2019-03-15
• Primary completion: 2025-01-27
• Completion: 2025-12-23
• First posted: 2018-11-14
• Last updated: 2026-01-27

Locations

56 sites across 10 countries: United States, Australia, France, Italy, Japan, Poland, South Korea, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study