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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20211017 | Registry Identifier | ChinaDrugTrials |
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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.
This study will have 3 cohorts for determining a monotherapy MTD and ramp-up schedule: Cohort A, participants with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R NHL); Cohort B, participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with low tumor burden; Cohort C, participants with R/R CLL/SLL with high tumor burden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: R/R NHL | Experimental | Participants with R/R NHL, including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), or transformed NHL, will receive oral BGB-11417 until the MTD (or maximum ascending dose [MAD]) and the RP2D can be determined. |
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| Cohort B: R/R CLL/SLL (low tumor burden) | Experimental | Participants with low tumor burden R/R CLL/SLL will receive oral BGB-11417 until the MTD (or MAD) and the RP2D can be determined. |
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| Cohort C: R/R CLL/SLL (high tumor burden) | Experimental | Participants in this cohort will not be enrolled until the RP2D for Cohort B is established. Participants will be treated with the monotherapy ramp-up schedule and the RP2D established in Cohort B. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-11417 | Drug | Film-coated tablets administered orally as specified in the treatment arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| MTD Of BGB-11417 As Recommended By The Bayesian Logistic Regression Model Or The MAD | Approximately 3 years | |
| RP2D Of BGB-11417 | The RP2D will be decided by the sponsor and based on the safety monitoring committee recommendation considering totality of data. | Approximately 3 years |
| Incidence And Severity Of Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events (AEs) Leading To Discontinuation, And Dose-Limiting Toxicities (DLTs) | All AEs, including DLT events, will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (or the Grading Scale for Hematologic Toxicity in CLL Studies as appropriate). | Approximately 3 years |
| Incidence And Severity Of Tumor Lysis Syndrome-relevant Events | Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 | Up to 24 hours postdose | |
| PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) Of BGB-11417 |
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Key Inclusion Criteria:
Confirmed diagnosis of only one of the following:
Cohort A
a. Marginal Zone Lymphoma
i. R/R extranodal, splenic or nodal disease defined as disease that has relapsed after, or been refractory to, ≥ 1 line of anti-CD20 antibody-based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for MZL is available per investigator's assessment.
ii. Active disease requiring treatment.
b. Follicular Lymphoma
i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that has relapsed after, or been refractory to, ≥ 1 line of anti-CD20 antibody-based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for FL is available per investigator's assessment.
ii. Active disease requiring treatment.
c. Diffuse Large B-cell Lymphoma
i. R/R DLBCL defined as disease that relapsed after, or been refractory to, at least one line of anti-CD20 antibody based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for DLBCL is available per investigator's assessment.
ii. Active disease requiring treatment.
d. Transformed indolent B-cell NHL
i. Any lymphoma otherwise eligible for Cohort A that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Cohort A.
ii. Active disease requiring treatment.
Cohorts B and C
a. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria:
i. R/R disease defined as disease that has relapsed after, or been refractory to, ≥ 1 line of standard therapy for ≥ 2 consecutive cycles, and no effective standard therapy is available per investigator's assessment.
ii. Requiring treatment based on IWCLL criteria.
Measurable disease by computed tomography/magnetic resonance imaging, defined as:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lu Zhang, M.D. | BeiGene (Suzhou) Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| Peking University Peoples Hospital |
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| Up to 24 hours postdose |
| PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) Of BGB-11417 | Up to 24 hours postdose |
| PK As Assessed By Time To Maximum Observed Plasma Concentration (tmax) Of BGB-11417 | Up to 24 hours postdose |
| PK As Assessed By Terminal Half-life (t1/2) Of BGB-11417 | Up to 24 hours postdose |
| PK As Assessed By Apparent Total Clearance Of Drug From Plasma After Oral Administration (CL/F) Of BGB-11417 | Up to 24 hours postdose |
| PK As Assessed By Apparent Volume Of Distribution (Vz/F) Of BGB-11417 | Up to 24 hours postdose |
| PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To Last Measurable Concentration At Steady State (AUClast,ss) Of BGB-11417 | Up to 24 hours postdose |
| PK As Assessed By Maximum Observed Plasma Concentration At Steady State (Cmax,ss) Of BGB-11417 | Up to 24 hours postdose |
| PK As Assessed By Trough Concentration At Steady State (Ctrough,ss) Of BGB-11417 | Up to 24 hours postdose |
| PK As Assessed By Time To Maximum Observed Plasma Concentration At Steady State (tmax,ss) Of BGB-11417 | Up to 24 hours postdose |
| Overall Response Rate (ORR) Of BGB-11417 Monotherapy | ORR will be assessed per disease-specific response assessment guidelines as determined by the investigator. | Approximately 3 years |
| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| Sun Yat Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Shenzhen Peoples Hospital | Shenzhen | Guangdong | 518020 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | 330006 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |