Clinical trials: active, sponsored by BeOne Medicines
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)
The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma…
- Trial name
- NCT06943872
- Testing
- Sonrotoclax, Obinutuzumab, Rituximab
- Where
- 195 sites in United States, Argentina and 19 more
- Volunteers
- 630 people
- Sponsor
- BeOne Medicines
RAS Mutation, Advanced Solid Tumor
A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations
The purpose of this study is to test if the BG-85738 is safe and if it works in patients with advanced solid tumors with RAS mutations when it is given on its own and in combination.
- Conditions
- RAS Mutation, Advanced Solid Tumor, Metastatic Solid Tumor
- Trial name
- NCT07746141
- Testing
- BG-85738, Tislelizumab, Cetuximab
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 100 people
- Sponsor
- BeOne Medicines
Healthy Adult Participants
A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395
This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.
- Trial name
- NCT07820891
- Testing
- BGB-43395, Midazolam, Celecoxib
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
B-cell Malignancy, Non-Hodgkin Lymphoma
Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
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…
- Conditions
- B-cell Malignancy, Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Trial name
- NCT05294731
- Testing
- Tacabrutideg
- Where
- 29 sites in China
- Volunteers
- 146 people
- Sponsor
- BeOne Medicines
Diffuse Large B-Cell Lymphoma, B-cell Malignancies
A Study Investigating the Safety and How the Trispecific T-Cell Engaging Antibody BG-T0920 Works in Adults With Diffuse Large B-cell Lymphoma (DLBCL) and Other Aggressive B-Cell Malignancies
The purpose of this study is to test the safety and tolerability of BG-T0920 and to identify the recommended dose and dosing schedule (including dose levels and timing) that can be taken without having serious side effects in…
- Trial name
- NCT07887646
- Testing
- BG-T0920
- Volunteers
- 70 people
- Sponsor
- BeOne Medicines
Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent
A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult…
- Conditions
- Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory
- Trial name
- NCT05952037
- Testing
- Sonrotoclax, Zanubrutinib
- Where
- 72 sites in United States, Australia and 7 more
- Volunteers
- 114 people
- Sponsor
- BeOne Medicines
Advanced Solid Tumor
An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors
This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in…
- Trial name
- NCT06589596
- Testing
- BGB-58067, BG-89894, Standard of Care Therapy
- Where
- 101 sites in United States, Australia and 9 more
- Volunteers
- 695 people
- Sponsor
- BeOne Medicines
Hepatic Impairment, Healthy Adult Participants
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
The goal of this study is to understand how the body processes sonrotoclax in adults with serious liver problems compared to adults with normal liver function.
- Trial name
- NCT07855991
- Testing
- Sonrotoclax
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
Diffuse Large B-Cell Lymphoma, B-Cell Malignancies
A Study Investigating the Safety and How the Trispecific T-Cell Engaging Antibody BG-T0050 Works in Adults With Diffuse Large B-cell Lymphoma (DLBCL) and Other Aggressive B-Cell Malignancies
The purpose of this study is to test the safety and tolerability of BG-T0050 and to identify the recommended dose and dosing schedule (including dose levels and timing) that can be taken without having serious side effects in…
- Trial name
- NCT07881211
- Testing
- BG-T0050
- Volunteers
- 70 people
- Sponsor
- BeOne Medicines
HR+/HER2- Breast Cancer
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole…
- Trial name
- KANDELA-302 (NCT07492641)
- Testing
- BGB-43395, Letrozole, Abemaciclib
- Where
- 206 sites in United States, Australia and 14 more
- Volunteers
- 1,056 people
- Sponsor
- BeOne Medicines
Advanced Unresectable Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma
A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States
The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor…
- Conditions
- Advanced Unresectable Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Advanced Gastroesophageal Adenocarcinoma
- Trial name
- NCT07554521
- Testing
- Tislelizumab, Capecitabine, 5-fluorouracil (5-FU)
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- BeOne Medicines
Relapsed/Refractory Follicular Lymphoma, Marginal Zone Lymphoma
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by…
- Trial name
- MAHOGANY (NCT05100862)
- Testing
- Zanubrutinib, Rituximab, Lenalidomide
- Where
- 264 sites in United States, Argentina and 26 more
- Volunteers
- 799 people
- Sponsor
- BeOne Medicines
Advanced Solid Tumor, Advanced Breast Cancer
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in…
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- NCT06120283
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 433 people
- Sponsor
- BeOne Medicines
Advanced Non-Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
A Study to Investigate Treatment Patterns and Effectiveness of Tislelizumab in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC)
The purpose of this study is to collect real-world data on treatment patterns and clinical outcomes in European patients receiving tislelizumab in routine clinical practice
- Trial name
- TITANS (NCT07652736)
- Testing
- Tislelizumab
- Where
- 6 sites in Spain
- Volunteers
- 440 people
- Sponsor
- BeOne Medicines
CLL
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)
- Trial name
- NCT06073821
- Testing
- Sonrotoclax, Zanubrutinib, Venetoclax
- Where
- 201 sites in United States, Australia and 19 more
- Volunteers
- 652 people
- Sponsor
- BeOne Medicines
Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric…
- Trial name
- NCT07043400
- Testing
- Subcutaneous Tislelizumab, Intravenous Tislelizumab, Cisplatin
- Where
- 95 sites in United States, Argentina and 14 more
- Volunteers
- 351 people
- Sponsor
- BeOne Medicines
Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of tislelizumab administered once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in combination with chemotherapy as first-line…
- Trial name
- NCT07733180
- Testing
- Tislelizumab, Oxaliplatin, Leucovorin
- Where
- 3 sites in Japan
- Volunteers
- 30 people
- Sponsor
- BeOne Medicines
Healthy Volunteers
A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants
This study is being done to understand how the body processes the study drug (BGB-58067) when it is taken together with other medicines. BGB-58067 is mainly broken down in the body by a liver enzyme called CYP3A.
- Trial name
- NCT07590102
- Testing
- BGB-58067, Phenytoin, Itraconazole
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
B-cell Malignancy, Marginal Zone Lymphoma
A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies
Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion…
- Conditions
- B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma
- Trial name
- CaDAnCe-101 (NCT05006716)
- Testing
- Tacabrutideg
- Where
- 114 sites in United States, Australia and 14 more
- Volunteers
- 689 people
- Sponsor
- BeOne Medicines
Hepatic Impairment, Healthy Adult Participants
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
The goal of this study is to understand how the body processes tacabrutideg in adults with different levels of liver function (normal, moderate impairment, and severe impairment).
- Trial name
- NCT07856004
- Testing
- Tacabrutideg
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines