A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Provided written informed consent

• 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

• Ability to swallow tablets and comply with study requirements for the duration of study participation

• Male and female patients of reproductive potential: Willing to observe conventional and effective birth control methods

• Male patients: agree not to donate sperm during and for 6 months after the study

• Dose Expansion Cohort 3 patients: prior treatment with pirtobrutinib (Jaypirca) for an approved indication

Locations
United States
California
UC Irvine Health
RECRUITING
Orange
Florida
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Moffitt Cancer Center
RECRUITING
Tampa
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Massachusetts
University of Massachusetts Memorial Medical Center
RECRUITING
Worcester
Maryland
University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center
RECRUITING
Baltimore
North Carolina
Duke University
RECRUITING
Durham
New York
Clinical Research Alliance, Inc.
RECRUITING
Westbury
Ohio
Taylor Cancer Research Center
RECRUITING
Maumee
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Wisconsin
The Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Akinori Arimura, PhD
clinical_us@dd.carnabio.com
650-636-4603
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 120
Treatments
Experimental: Dose Escalation
Dose escalation (3+3 design) and determination of MTD and DLTs~CLL/SLL or B-cell NHL patients will self-administer docirbrutinib oral tablet at multiple dose levels twice daily for 24 cycles (1 cycle = 28 days).
Experimental: Dose Expansion
Cohort 1: CLL/SLL patients, Cohort 2: B-cell NHL patients, Cohort 3: CLL/SLL or B-cell NHL patients with prior treatment with pirtobrutinib (Jaypirca) for an approved indication~Patients will self-administer docirbrutinib oral tablet for 24 cycles (1 cycle = 28 days). Dose levels will be determined based on the result of dose escalation part.
Sponsors
Leads: Carna Biosciences, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials