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

Launched by CARNA BIOSCIENCES, INC. · Oct 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new oral medication called AS-1763 (docirbrutinib) for patients with certain types of blood cancers, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and various forms of non-Hodgkin lymphoma (NHL). The trial is looking for adults aged 18 and older who have already tried at least two different treatments without success or who could not tolerate those treatments. Participants must have a confirmed diagnosis and meet specific health criteria to join.

If you participate in this study, you'll be taking the medication and will be monitored closely to see how it affects your condition. The trial is open to all genders, and participants will need to follow certain guidelines, such as using birth control if they are of reproductive age. It's important to note that this is an early-phase study, which means researchers are primarily focused on understanding the safety and effectiveness of the drug. If you are interested or think you might qualify, consider discussing it with your healthcare provider for more information.

Gender

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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