AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma
Start Date
8/1/2023
Completion Date
9/1/2027
Summary
This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL/SLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.
Detailed Description
This study consists of 2 parts. Dose escalation part will enroll up to 27 patients to evaluate safety profile and tolerance of docirbrutinib using 3+3 design. The starting dose of docirbrutinib in oral tablet form is 100 mg twice daily (200 mg/day). Dose escalation will continue up to the planned maximum dose level or until the maximum tolerated dose (MTD) has been identified. Dose expansion part will enroll up to 48 CLL/SLL patients (Cohort 1), up to 35 NHL patients (Cohort 2), and up to 10 patients with prior pirtobrutinib treatment for an approved indication (Cohort 3). The first 30 patients in each Cohort 1 or 2 will be allocated to three dose levels (n=10 at each dose level) which will be selected based on the data from dose escalation. Preliminary efficacy and safety data from the first 30 patients in one of cohorts will be used to identify the provisional recommended Phase 2 dose (RP2D) level. Thereafter, up to a further 18 patients for Cohort 1 and up to a further 5 patients for Cohort 2 will be enrolled and allocated to the provisional RP2D level. Cohort 3 will be enrolled in parallel with Cohorts 1 and 2 and will be allocated to up to two dose levels (either n=10 at a single dose level or n=5 at each of 2 dose levels). Study assessments will continue for 24 cycles (1 cycle = 28 days) or until disease progression, occurrence of unacceptable toxicity, or discontinuation because of other reasons. Patients will then be followed for survival status for a further 2 years. RP2D will be determined based on all the data generated in the study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Docirbrutinib
Conditions
Locations
UC Irvine Health
Orange, California 92868
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Northwestern Memorial Hospital
Chicago, Illinois 60661
United States
American Oncology Partners
Fort Wayne, Indiana 46804
United States
University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
United States
Optum Medical Care PC
Westbury, New York 11590
United States
Duke University
Durham, North Carolina 27705
United States
Taylor Cancer Research Center
Maumee, Ohio 43537
United States
Oncology Consultants
Houston, Texas 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
The Medical College of Wisconsin
Milwaukee, Wisconsin 53266
United States