Clinical Trials in China / NCT05294731
Recruiting
Phase 1/2
Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
NCT05294731 · tracked via the Priya Life Science China tracker
Condition(s) studied
B-cell MalignancyNon-Hodgkin LymphomaMantle Cell LymphomaChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaWaldenström MacroglobulinemiaMarginal Zone LymphomaFollicular LymphomaDLBCL UnclassifiableRichter's Transformation
Study summary
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
Eligibility
Key Inclusion Criteria
1. Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
3. Adequate hematologic, coagulation, renal, pancreatic, and hepatic function, and measurable disease according to disease-specific criteria, as applicable
4. Phase 1: Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL/SLL
5. Phase 2: Confirmed diagnosis of MCL, or CLL/SLL
6. Highly effective method of birth control during study treatment period, and for ≥ 30 days after the last dose of the study drug
Key Exclusion Criteria
1. 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
2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment
3. Current or history of central nervous involvement
4. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Primary outcome measure(s)
- Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs) — 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)
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. - Phase 1: Recommended Phase 2 dose (RP2D) of Tacabrutideg — From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)
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. - Phase 1a: Maximum tolerated dose (MTD) of Tacabrutideg — From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)
The highest dose evaluated as recommended by the Bayesian Optimal Interval Design with Informative Prior (iBOIN) design or the maximum assessed dose (MAD). - Phase 2: Overall Response Rate (ORR) in participants with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) — Up to approximately 3 years
ORR is defined as the percentage of participants with partial response or better according to the Investigators assessment and as determined by Lugano criteria. - Phase 2: ORR in participants with R/R Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) — Up to approximately 3 years
ORR is defined as the percentage of participants with partial response or better as assessed by the Independent Review Committee (IRC) and determined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL and by Lugano criteria for SLL
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | Recruiting |
| Anhui Provincial Hospital | Hefei | Anhui | Recruiting |
| Peking University Third Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Chao Yang Hospital,Capital Medical University | Beijing | Beijing Municipality | Recruiting |
| Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) | Chongqing | Chongqing Municipality | Recruiting |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | Recruiting |
| Sun Yat Sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| Guangdong Provincial Peoples Hospital Huifu Branch | Guangzhou | Guangdong | Recruiting |
| The Peoples Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | Recruiting |
| Nanyang Central Hospital | Nanyang | Henan | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| Xiangyang Central Hospital | Xiangyang | Hubei | Recruiting |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | Recruiting |
| Jiangsu Province Hospital | Nanjing | Jiangsu | Recruiting |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | Recruiting |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | Recruiting |
| Jiangxi Province Cancer Hospital | Nanchang | Jiangxi | Recruiting |
| The First Hospital of Jilin University | Changchun | Jilin | Recruiting |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | Liaoning | Recruiting |
| Shandong Cancer Hospital | Jinan | Shandong | Recruiting |
| Qingdao Central Hospital | Qingdao | Shandong | Recruiting |
| Rui Jin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | Recruiting |
| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | Recruiting |
| West China Hospital, Sichuan University | Chengdu | Sichuan | Recruiting |
| Institute of Hematology and Hospital of Blood Disease | Tianjin | Tianjin Municipality | Recruiting |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine Branch Yuhang | Hangzhou | Zhejiang | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05294731 on ClinicalTrials.gov ↗ ← All trials in China