Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies (NCT04883957) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies
China64 participantsStarted 2021-07-05
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of BGB-11417 monotherapy, define the maximum tolerated dose (MTD) or maximum administered dose and the recommended Phase 2 dose (RP2D) of BGB-11417 monotherapy for the selected B-cell malignancy dose finding cohorts, and evaluate the safety and tolerability of the ramp-up dosing schedule in the evaluated disease types.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Confirmed diagnosis of only one of the following:
✓. Measurable disease by computed tomography/magnetic resonance imaging, defined as:
✓. CLL: At least 1 lymph node \> 1.5 centimeters (cm) in longest diameter and measurable in 2 perpendicular dimensions. For Cohort B, participants should not meet with the definition of high tumor burden, which is required for participants enrolled in Cohort C.
✓. DLBCL, FL, MZL, SLL: At least 1 lymph node \> 1.5 cm in longest diameter OR 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions. For MZL isolated splenomegaly is considered to indicate measurable disease for this study. For SLL, participants in Cohort B should not meet with the definition of high tumor burden, which is required for participants enrolled in Cohort C.
Exclusion criteria
✕. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer.
✕. Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results.
✕. Known central nervous system involvement by lymphoma/leukemia.
✕. Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome.
✕. Prior autologous stem cell transplant unless ≥ 3 months after transplant; or prior chimeric cell therapy unless ≥ 6 months after cell infusion.
What they're measuring
1
MTD Of BGB-11417 As Recommended By The Bayesian Logistic Regression Model Or The MAD
Timeframe: Approximately 3 years
2
RP2D Of BGB-11417
Timeframe: Approximately 3 years
3
Incidence And Severity Of Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events (AEs) Leading To Discontinuation, And Dose-Limiting Toxicities (DLTs)
Timeframe: Approximately 3 years
4
Incidence And Severity Of Tumor Lysis Syndrome-relevant Events