RecruitingPhase 1Phase 2NCT05294731

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

A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies

Sponsor

BeiGene

Enrollment

146 participants

Start Date

May 6, 2022

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Richter's Transformation B-cell Malignancy Waldenström Macroglobulinemia DLBCL Unclassifiable

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new targeted drug called BGB-16673 in Chinese patients with various types of B-cell blood cancers that have come back or stopped responding to prior treatments. The drug works by degrading a protein called BTK that helps cancer cells survive. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of a relapsed or refractory B-cell cancer such as mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL/SLL), follicular lymphoma, marginal zone lymphoma, Waldenström macroglobulinemia, or diffuse large B-cell lymphoma - You are in reasonably good general health (ECOG 0–2) - Your organ function (kidneys, liver, blood) meets the required levels - You are willing to use effective contraception during treatment **You may NOT be eligible if...** - Your cancer has not been confirmed as relapsed or refractory - You have significant organ dysfunction - You are pregnant or breastfeeding - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-16673

Orally administered

Locations(29)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Beijing Chao Yang Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Provincial Peoples Hospital Huifu Branch

Guangzhou, Guangdong, China

The Peoples Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Nanyang Central Hospital

Nanyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

Jiangxi Province Cancer Hospital

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Qingdao Central Hospital

Qingdao, Shandong, China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First Affiliated Hospital, Zhejiang University School of Medicine Branch Yuhang

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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NCT05294731

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