Docirbrutinib (AS-1763) in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma

Study Details - NCT05602363

Summary

Phase

Phase 1b

Dose escalation part
Dose expansion part

Medical Conditions

B-cell malignancy

Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Waldenstrom Macroglobulinemia (WM)
Mantle Cell Lymphoma (MCL)
Marginal Zone Lymphoma (MZL)
Follicular Lymphoma (FL)

Age Range: 18 years+

Overview

This is an open-label, multi-center Phase 1b clinical study of oral docirbrutinib (AS-1763) in patients with CLL/SLL or B-cell non-Hodgkin lymphoma (B-cell NHL) who have failed or are intolerant to ≥2 lines of systemic therapy.

Key Eligibility Criteria

Inclusion Criteria

Age ≥18 years
Histologically confirmed B-cell malignancy, including CLL/SLL, WM, MCL, MZL, or FL.
Patients with SLL, MCL, MZL, and FL: at least 1 radiographically measurable lesion
Failed or are intolerant to ≥2 prior lines of systemic therapy
ECOG Performance Status 0 to 2
Adequate hematologic status (ie, absolute neutrophil count ≥0.75 × 10⁹/L, platelet count ≥50 × 10⁹/L, hemoglobin ≥8 g/dL) not requiring transfusion support or growth factors
Adequate hepatic function
Adequate renal function
Dose Expansion Cohort 3 patients: prior treatment with pirtobrutinib (Jaypirca) for an approved indication

Exclusion Criteria

Transformed disease (eg, Richter's transformation) prior to or during Screening
Investigational agent or anticancer therapy within 5 half-lives before the planned start of docirbrutinib, except therapeutic monoclonal antibody treatment which must be discontinued at least 4 weeks before the start of docirbrutinib.
Current treatment with investigational therapy or planned investigational therapy which would be concurrent with this study.
Requiring therapeutic anticoagulation with warfarin.
Refractory to transfusion support.
Major surgery within 4 weeks before planned start of docirbrutinib.
Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment
Any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 2 at the time of starting study treatment except for alopecia.
History of allogeneic or autologous stem cell transplant or CAR-T therapy within the last 30 days.
Active second malignancy unless in remission with life expectancy >2 years
Known central nervous system (CNS) involvement by systemic lymphoma.
Active uncontrolled autoimmune cytopenia (eg, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura) where new therapy introduced or concomitant therapy escalated within the 4 weeks before study enrollment is required to maintain adequate blood counts.
Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months before planned start of docirbrutinib, or prolongation of the QT interval corrected for heart rate using Fridericia's Formula (QTcF) >470 msec on at least 2 of 3 consecutive ECGs, and mean QTcF >470 msec on all 3 ECGs, during Screening.
Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
Dose Escalation and Cohort 3 patients: prior treatment with noncovalent BTKi except pirtobrutinib (Jaypirca)
Dose Expansion Cohort 1 and Cohort 2 patients: prior treatment with any noncovalent BTKi

Trial Site Locations

This study has 9 locations

United States

California Locations

Orange, California, United States, 92868

Recruiting

UC Irvine Health

Contact:

Catherine Coombs, MD
714-456-8000 ucstudy@hs.uci.edu

Principal Investigator:

Catherine Coombs, MD

Florida Locations

Miami Beach, Florida, United States, 33140

Recruiting

Mount Sinai Comprehensive Cancer Center

Contact:

Yvonne Enriquez
305-674-2625 yvonne.enriquez@msmc.com

Principal Investigator:

Jacqueline Barrientos, MD

Tampa, Florida, United States, 33612

Recruiting

Moffitt Cancer Center

Contact:

Richard Corona
813-745-3465 richard.corona@moffitt.org

Principal Investigator:

Javier Pinilla-Ibarz, MD PhD

Illinoi Locations

Chicago, Illinois, United States, 60661

Recruiting

Northwestern Memorial Hospital

Contact:

Study Cordinator
312-695-1301 cancer@northwestern.edu

Principal Investigator:

Shuo Ma, MD PhD

Maryland Locations

Baltimore, Maryland, United States, 21201

Recruiting

University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center

Contact:

Nikki M Glynn-Cunningham, MS
410-328-7996 nglynn@umm.edu

Principal Investigator:

Seung Tae Lee, MD PhD

Massachusetts Locations

Worcester, Massachusetts, United States, 01655

Recruiting

University of Massachusetts Memorial Medical Center

Contact:

UMass Cancer Research Office
508-856-3216 cancer.research@umassmed.edu

Principal Investigator:

Andrew J Gillis-Smith, MD

New York Locations

Westbury, New York, United States, 11590

Recruiting

Clinical Research Alliance, Inc.

Contact:

James T D’Olimpio, MD FACP FAAHPM
646-872-8630 jdolimpio@researchcra.com

Principal Investigator:

James T D’Olimpio, MD FACP FAAHPM

Texas Locations

Houston, Texas, United States, 77030

Recruiting

University of Texas MD Anderson Cancer Center

Contact:

Nitin Jain, MD
713-745-6080 njain@mdanderson.org

Principal Investigator:

Nitin Jain, MD

Wisconsin Locations

Milwaukee, Wisconsin, United States, 53266

Recruiting

The Medical College of Wisconsin

Contact:

Medical College of Wisconsin Cancer Center Clinical Trials Office
414-805-8900 cccto@mcw.edu

Principal Investigator:

Nirav Shah, MD

Click to view interactive map