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  • Cancer Type: Malignant Hematology
  • Study Type: Treatment
  • NCT#: NCT05602363
  • Phase: Phase I
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  • Overview

    Study Title:

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


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


    Primary Objective: To determine the MTD and DLTs in patients with previously treated CLL/SLL or B-cell NHL. Secondary Objective(s): To evaluate the safety profile and tolerability of AS-1763 in patients with previously treated CLL/SLL or B-cell NHL. To evaluate the plasma PK of AS-1763. To assess the preliminary anti-tumor activity of AS-1763 based on ORR according to iwCLL 2018 for CLL, IWWM6 for WM, Lugano Treatment Response Criteria for MCL, MZL, SLL, FL, and other B-cell NHL, or other criteria as appropriate to tumor type, as assessed by the investigator.

  • Treatments


    Therapy (NOS)


    AS-1763 ()

  • Inclusion Criteria

      Inclusion Criteria:
    • Age ≥18 years
    • Provided written informed consent
    • Histologically confirmed B-cell malignancy, including CLL/SLL, WM, MCL, MZL, or FL. Patients must have failed or are intolerant to ≥2 prior lines of systemic therapy
    • ECOG Performance Status 0 to 2
    • Adequate organ 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
    • Other criteria apply
  • Exclusion Criteria

      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 AS-1763, except therapeutic monoclonal antibody treatment which must be discontinued at least 4 weeks before the start of AS-1763. Current treatment with investigational therapy or planned investigational therapy which would be concurrent with this study.
    • Requiring therapeutic anticoagulation with warfarin.
    • Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
    • Treatment with proton pump inhibitors within 7 days before first dose of AS-1763
    • Current treatment with strong P-glycoprotein inhibitors or strong breast cancer resistance protein (BCRP) inhibitors.
    • Refractory to transfusion support.
    • Major surgery within 4 weeks before planned start of AS-1763.
    • 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 chimeric antigen receptor T-cell (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. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of disease may be eligible if a compelling clinical rationale is provided by the investigator and with documented Sponsor approval.
    • 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 AS-1763, 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
    • Positive for human immunodeficiency virus (HIV). For patients with unknown HIV status, HIV testing will be performed at Screening.
    • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of AS-1763
    • Pregnant or lactating.
    • Known hypersensitivity to any component or excipient of AS-1763.
    • Prior treatment with AS-1763 or other noncovalent BTKi such as pirtobrutinib or nemtabrutinib
    • Other exclusions may apply

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