ClinicaliQ Trial Snapshot
- A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies — Recruiting • Phase I • Cardiology / Cardiovascular • NCT05006716.
- What is being tested: BGB-16673 is a novel investigational agent being evaluated in a dose-escalation and expansion study to determine safe and effective dosing schedules for treating B-cell malignancies, progressing from Phase 1 monotherapy dose-finding through to Phase 2 expansion cohorts.
- Patient eligibility overview: The study enrolls patients with B-cell malignancies, with participation structured across dose-escalation cohorts and safety expansion phases, allowing assessment across different patient populations and disease stages within this cancer category.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
Eligibility Snapshot
- : 1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.
- Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance). 3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance. 4. Measurable disease by radiographic assessment or serum IgM level (WM only) 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.