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New treatment option for B-cell Malignancy
Official title AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT05602363
What this study is testing
What is Docirbrutinib?
Docirbrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for b-cell malignancy.
Also referred to as AS-1763.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Miami Beach, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Fort Wayne, Indiana, United States
- Baltimore, Maryland, United States
- Worcester, Massachusetts, United States
- Westbury, New York, United States
- Durham, North Carolina, United States
- Maumee, Ohio, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Miami Beach, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Fort Wayne, Indiana, United States; Baltimore, Maryland, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.