A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma
About this trial
This is an interventional treatment trial for B-cell Malignancy
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
- Age ≥ 18 years
- Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following: MZL, FL, MCL, CLL/SLL, or WM.
- Patients who have previously received a covalently-binding BTK inhibitor in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks.
- For dose-finding and dose-expansion, patients 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.
- Measurable disease by radiographic assessment or serum IgM level (WM only)
- ECOG Performance Status of 0 to 2
- Patients enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy; patients with CLL/SLL or MCL enrolling in the expansion cohorts must have been treated with a BTKi in a prior line of therapy.
Exclusion Criteria:
- Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
- Requires ongoing systemic treatment for any other malignancy
- Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
- Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether patient had received treatment for central nervous system disease
- Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, or history of or currently suspected Richter's transformation.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- University of Alabama At Birmingham HospitalRecruiting
- Mayo Clinic PhoenixRecruiting
- University of Arizona Cancer CenterRecruiting
- University of California San Diego (Ucsd) Moores Cancer CenterRecruiting
- Valkyrie Clinical TrialsRecruiting
- UCLA Santa Monica Cancer CareRecruiting
- Stanford MedicineRecruiting
- Mayo Clinic JacksonvilleRecruiting
- Tampa General Hospital Cancer InstituteRecruiting
- Norton Cancer Institute PavilionRecruiting
- Mary Bird Perkins Cancer CenterRecruiting
- Dana Farber Cancer InstituteRecruiting
- Mayo Clinic RochesterRecruiting
- Nebraska Cancer SpecialistsRecruiting
- Weill Cornell Medical College Newyork Presbyterian HospitalRecruiting
- Columbia University Medical CenterRecruiting
- Memorial Sloan Kettering Cancer Center MskccRecruiting
- Md Anderson Cancer CenterRecruiting
- Virginia Commonwealth University Massey Cancer CenterRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
- Concord Repatriation General HospitalRecruiting
- St Vincents Hospital MelbourneRecruiting
- Peter Maccallum Cancer CentreRecruiting
- The Alfred HospitalRecruiting
- Linear Clinical ResearchRecruiting
- Perth Blood InstituteRecruiting
- Tom Baker Cancer CenterRecruiting
- Arensia Exploratory Medicine LlcRecruiting
- Niguarda Cancer Center Division of HematologyRecruiting
- Centroricerche Cliniche Di Verona SrlRecruiting
- The Institute of Oncology, Arensia Exploratory MedicineRecruiting
- Hospital Universitario Vall DhebronRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Clinico Universitario de ValenciaRecruiting
- Karolinska Universitetssjukhuset SolnaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Part 1a (Monotherapy Dose Escalation)
Part 1b (Monotherapy Safety Expansion)
Part 1c (Additional Monotherapy Safety Expansion)
Part 2 (Monotherapy Dose Expansion)
Dose escalation in selected R/R B-Cell malignancies to inform safety, tolerability and MTD.
Additional participants with selected R/R B-Cell malignancies will be enrolled at selected doses to help inform the selection of the recommended phase two dose (RP2D).
After RP2D is determined, additional safety data will be collected to confirm RP2D for participants with selected B-cell malignancies not being evaluated in Part 2
The totality of the data from Part 1a and Part 1b will be used to further evaluate the safety and efficacy of BGB-16673 at the recommended dose(s) for Part 2 expansion in specific histologies.