Oral AS-1763 treatment for patients with certain blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multi-center Phase 1b clinical study evaluates the safety and efficacy of oral AS-1763 (docirbrutinib) in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin lymphoma (NHL) who have previously failed or are intolerant to at least two lines of systemic therapy. The study consists of a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to assess preliminary efficacy and safety across different cohorts of patients. Participants will be monitored for 24 cycles or until disease progression or unacceptable toxicity occurs.

Why it matters

Who can join: the full rules

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

Where it's running

• UC Irvine Health
  Orange, California, United States Recruiting
• Mount Sinai Comprehensive Cancer Center
  Miami Beach, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting
• American Oncology Partners
  Fort Wayne, Indiana, United States Recruiting
• University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Akinori Arimura, PhD
• Email: clinical_us@dd.carnabio.com
• Phone: 650-636-4603

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.