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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20220399 | Other Identifier | ChinaDrugTrials |
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This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a Monotherapy Dose Escalation | Experimental | BGB-16673 will be orally administered. |
|
| Phase 1b Monotherapy Safety Expansion | Experimental | BGB-16673 will be orally administered. |
|
| Phase 2 Monotherapy Dose Expansion | Experimental | BGB-16673 will be administered at the recommended Phase 2 dose (RP2D) that was identified in Part 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-16673 | Drug | Orally administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria. | From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years) |
| Phase 1: Recommended Phase 2 dose (RP2D) of BGB-16673 | As determined by the sponsor based on the Safety Monitoring Committee's recommendation considering totality of the available clinical safety, clinical efficacy, pharmacokinetics, and pharmacodynamics data. | From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks) |
| Phase 1a: Maximum tolerated dose (MTD) of BGB-16673 | The highest dose evaluated as recommended by the Bayesian Optimal Interval Design with Informative Prior (iBOIN) design or the maximum assessed dose (MAD). | From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks) |
| Phase 2: Overall Response Rate (ORR) in participants with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) | ORR is defined as the percentage of participants with partial response or better according to the Independent Review Committee (IRC) assessment and as determined by Lugano criteria. | Up to approximately 3 years |
| Phase 2: ORR in participants with R/R Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) | ORR is defined as the percentage of participants with partial response or better as assessed by the IRC and determined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL and by Lugano criteria for SLL |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) After a Single Dose of BGB-16673 | Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose | |
| Time to reach maximum observed plasma concentration (Tmax) After a Single Dose of BGB-16673 |
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Key Inclusion Criteria
Key Exclusion Criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BeiGene | Contact | 1.877.828.5568 | clinicaltrials@beigene.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Recruiting | Bengbu | Anhui | 233004 | China | |
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See plan description
See plan description
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| Up to approximately 3 years |
| Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose |
| Minimum observed plasma concentration (Cmin) After a Single Dose of BGB-16673 | Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose |
| Apparent terminal elimination half-life (t1/2) After a Single Dose of BGB-16673 | Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose |
| Area under the plasma-concentration curve (AUC) After a Single Dose of BGB-16673 | Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose |
| Apparent oral clearance (CL/F) After a Single Dose of BGB-16673 | Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose |
| Apparent volume of distribution (Vz/F) After a Single Dose of BGB-16673 | Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose |
| Maximum observed steady state plasma concentration (Css,max) of of BGB-16673 | Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose |
| Time to reach maximum observed steady state plasma concentration (Tss,max) of BGB-16673 | Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose |
| Minimum observed steady state plasma concentration (Css,min) of BGB-16673 | Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose |
| Steady state area under the plasma concentration-time curve (AUC) of BGB-16673 | Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose |
| Accumulation ratios of Cmax and AUC of BGB-16673 | Phase 1a: Day 1 pre-dose up to 72 hours post-dose, Week 5 pre-dose up to 8 hours post-dose; Phase 1b: Week 1 and Week 5 pre-dose up to 6 hours post-dose; Phase 2: Week 1 and Week 5 pre-dose up to 8 hours post-dose |
| Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after BGB-16673 monotherapy | Phase 1a: Day 1 pre-dose up to 72 hours post-dose, Week 5 pre-dose and 8 hours post-dose, Week 9 pre-dose; Phase 1b: Week 1 and Week 5 pre-dose and 6 hours post-dose, Week 9 pre-dose; Phase 2: Week 1, Week 5, Week 9 pre-dose |
| Phase 1: Overall Response Rate (ORR) | ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL), Owen, and Lugano criteria. | Up to approximately 3 years |
| Phase 1: Major Response Rate (MRR) in participants with Waldenstrom macroglobulinemia (WM) | MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), and partial response (PR), as assessed by investigators for participants with WM only. | Up to approximately 3 years |
| Phase 2: Number of participants with AEs and SAEs | Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0). | From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years) |
| Phase 2: ORR in participants with R/R MCL as assessed by investigators | ORR is defined as the percentage of participants with partial response or better according to investigators and as determined by Lugano criteria. | Up to approximately 3 years |
| Phase 2: Duration of Response (DOR) | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by IRC and by investigators. | Up to approximately 3 years |
| Phase 2: Time to Response (TTR) | TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) as determined by IRC and by investigators. | Up to approximately 3 years |
| Phase 2: Progression Free Survival (PFS) | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as determined by IRC and by investigators. | Up to approximately 3 years |
| Phase 2: Overall Survival (OS) | OS is defined as the time from first study drug administration to the date of death due to any cause. | Up to approximately 3 years |
| Phase 2: Best Overall Response (BOR) of Partial Response with Lymphocytosis (PR-L) in Participants with R/R CLL/SLL | BOR of PR-L or better as determined by IRC and by investigators per iwCLL criteria for CLL and per Lugano criteria for SLL | Up to approximately 3 years |
| Phase 2: Change from baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (NFLymSI-18) Disease-related Symptom Physical and Treatment Side Effect Subscales in participants with R/R MCL | The NFLymSI-18 questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score. A mixed model for repeated measures (MMRM) will be used to estimate the mean change from baseline for NFlymSI-18 subscales of Disease-Related Symptoms Physical (DRSP), and "treatment side effects" (TSE). | Baseline and Day 1 of weeks 5, 13, 25, and 37 |
| Phase 2: ORR assessed by the Investigator in participants with R/R CLL/SLL | ORR is defined as the percentage of participants with partial response or better as determined by investigators per iwCLL criteria for CLL and Lugano criteria for SLL. | Up to approximately 3 years |
| Phase 2: Mean change from baseline for the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu ) questionnaire Physical Well-being and Functional Well-being Subscales for participants with R/R CLL/SLL | FACT-Leu is a 44-item patient reported outcome questionnaire with five subscales used to measure health-related quality of life (HRQoL) in leukemia patients. Each question is scored from 0 (not at all) to 4 (very much). | Baseline and Day 1 of weeks 5, 13, 25, and 37 |
| Anhui Provincial Hospital |
| Recruiting |
| Hefei |
| Anhui |
| 230000 |
| China |
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| Beijing Chao Yang Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100020 | China |
| Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
| Sun Yat Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| Guangdong Provincial Peoples Hospital Huifu Branch | Recruiting | Guangzhou | Guangdong | 510120 | China |
| The Peoples Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | Guangxi | 530021 | China |
| Nanyang Central Hospital | Recruiting | Nanyang | Henan | 473000 | China |
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
| Xiangyang Central Hospital | Recruiting | Xiangyang | Hubei | 441021 | China |
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Recruiting | Nanchang | Jiangxi | 330006 | China |
| Jiangxi Province Cancer Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
| Affiliated Zhongshan Hospital of Dalian University | Recruiting | Dalian | Liaoning | 116001 | China |
| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
| Qingdao Central Hospital | Recruiting | Qingdao | Shandong | 266031 | China |
| Rui Jin Hospital Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | Shanxi | 030013 | China |
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
| Institute of Hematology and Hospital of Blood Disease | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650032 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine Branch Yuhang | Recruiting | Hangzhou | Zhejiang | 311121 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D016393 | Lymphoma, B-Cell |
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