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Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader

NCT05294731

RecruitingPhase 1, Phase 2

Sponsor: BeiGene

Conditions: B-cell Malignancy, Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Waldenström Macroglobulinemia

Interventions: BGB-16673

Countries: China

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria

1. Provision of signed and dated written informed consent prior to any study
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria
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 at least 90 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. Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.
4. Current or history of central nervous involvement
5. 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

Locations (29)

Bengbu, Anhui, China
Hefei, Anhui, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Nanyang, Henan, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Xiangyang, Hubei, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Suzhou, Jiangsu, China
Nanchang, Jiangxi, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Dalian, Liaoning, China
Jinan, Shandong, China
Qingdao, Shandong, China
Shanghai, Shanghai Municipality, China
Taiyuan, Shanxi, China
Chengdu, Sichuan, China
Tianjin, Tianjin Municipality, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China