AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma
A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The starting dose of docirbrutinib in oral tablet form is 100 mg twice daily (200 mg/day)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * 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 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 * Current treatment with certain strong CYP3A4 inhibitors or inducers * Treatment with proton pump inhibitors within 7 days before first dose of docirbrutinib * Current treatment with strong P-glycoprotein inhibitors or strong BCRP inhibitors * 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 * Positive for 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 docirbrutinib * Pregnant or lactating. * Known hypersensitivity to any component or excipient of docirbrutinib * Prior treatment with docirbrutinib * 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
Study sites (13)
CA
- UC Irvine Health · Orange, CA 92868Catherine Coombs, MD · Study contact · 714-456-8000 · ucstudy@hs.uci.eduCatherine Coombs, MD · Principal investigatorMore trials in Orange
FL
- Mount Sinai Comprehensive Cancer Center · Miami Beach, FL 33140Yvonne Enriquez · Study contact · 305-674-2625 · yvonne.enriquez@msmc.comJacqueline Barrientos, MD · Principal investigatorMore trials in Miami Beach
- Moffitt Cancer Center · Tampa, FL 33612Richard Corona · Study contact · (813) 745-3465 · richard.corona@moffitt.orgJavier Pinilla-Ibarz, MD PhD · Principal investigatorMore trials in Tampa
IL
- Northwestern Memorial Hospital · Chicago, IL 60661Study Cordinator · Study contact · (312) 695 1301 · cancer@northwestern.eduShuo Ma, MD PhD · Principal investigatorMore trials in Chicago
IN
- American Oncology Partners · Fort Wayne, IN 46804Phil Hutson · Study contact · 260-312-2219 · phil.hutson@aoncology.comSunil Babu, MD · Principal investigatorMore trials in Fort Wayne
MA
- University of Massachusetts Memorial Medical Center · Worcester, MA 01655UMass Cancer Research Office · Study contact · 508-856-3216 · cancer.research@umassmed.eduAndrew J Gillis-Smith, MD · Principal investigatorMore trials in Worcester
MD
- University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center · Baltimore, MD 21201Nikki M Glynn-Cunningham, MS · Study contact · 410-328-7996 · nglynn@umm.eduSeung Tae Lee, MD PhD · Principal investigatorMore trials in Baltimore
NC
- Duke University · Durham, NC 27705Terri Lucas · Study contact · 919-681-6580 · terri.lucas@duke.eduDanielle Brander, MD · Principal investigatorMore trials in Durham
NY
- Optum Medical Care PC · Westbury, NY 11590Jonathan Goldberg, MD · Study contact · 914-241-1050 ext. 3512 · jgoldberg@caremount.comJonathan Goldberg, MD · Principal investigatorMore trials in Westbury
OH
- Taylor Cancer Research Center · Maumee, OH 43537Nadine Nemunaitis · Study contact · 567-402-4501 · nnemunaitis@tcrcpt.orgJohn Nemunaitis, MD · Principal investigatorMore trials in Maumee
TX
- Oncology Consultants · Houston, TX 77030Laura Guerra, RN, CCRC · Study contact · 713-516-4968 · lguerra@oncologyconsultants.comMarisol Dominguez · Study contact · 832-333-1480 · mdominguez@oncologyconsultants.comJulio A Peguero, MD · Principal investigatorMore trials in Houston
- University of Texas MD Anderson Cancer Center · Houston, TX 77030Nitin Jain, MD · Study contact · 713-745-6080 · njain@mdanderson.orgNitin Jain, MD · Principal investigatorMore trials in Houston
WI
- The Medical College of Wisconsin · Milwaukee, WI 53266Medical College of Wisconsin Cancer Center Clinical Trials Office · Study contact · 414-805-8900 · cccto@mcw.eduNirav Shah, MD · Principal investigatorMore trials in Milwaukee