Clinical trials: sponsored by BeOne Medicines
Glioblastoma (GBM)
BGB-58067 in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors
This is an open-label, multi-center, Phase 0/2 trial designed to enroll up to 78 total participants with suspected newly diagnosed glioblastoma (nGBM) who are scheduled for surgical resection to accrue at least 14 participants in…
- Trial name
- NCT07485049
- Testing
- BGB-58067
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Nader Sanai
Non-small Cell Lung Cancer
Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer
This is an open-label, multicenter, Phase 1 clinical study to evaluate the bioavailability of tislelizumab subcutaneous (SC) injection in the first-line treatment of participants with advanced or metastatic non-small cell lung…
- Trial name
- NCT06091943
- Testing
- Tislelizumab IV, Tislelizumab SC, Histology-Based Chemotherapy Doublet
- Where
- 15 sites in China, Georgia and 1 more
- Volunteers
- 62 people
- Sponsor
- BeiGene
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (SLL)
Zanubrutinib, Obinutuzumab, Sonrotoclax (BOSon) or BGB-16673, Obinutuzumab, Sonrotoclax (DOSon) in TN CLL/SLL
The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Trial name
- NCT06849713
- Testing
- Zanubrutinib, Sonrotoclax, Obinutuzumab
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Massachusetts General Hospital
Waldenström's Macroglobulinemia
A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
The purpose of this study is to measure the efficacy and safety with zanubrutinib in adults with Treatment-Naive (TN) Waldenström Macroglobulinemia (WM).
- Trial name
- NCT07169331
- Testing
- Zanubrutinib
- Where
- 6 sites in China
- Volunteers
- 16 people
- Sponsor
- BeiGene
Skin Diseases
A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases
This is the first-in-human study of BG-A3004. The study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of BG-A3004 after single and multiple doses administered in…
- Trial name
- NCT07412691
- Testing
- BG-A3004
- Where
- 11 sites in China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
Waldenstrom Macroglobulinemia
Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations…
- Trial name
- NCT05640102
- Testing
- Zanubrutinib
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 111 people
- Sponsor
- BeiGene
Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
A Study Investigating the Efficacy and Safety of Alcestobart (LBL-007) Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer
This is a Phase 1b/2 study to investigate the efficacy and safety of alcestobart (LBL-007) plus tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine, and alcestobart in combination with bevacizumab…
- Trial name
- NCT05609370
- Testing
- Alcestobart, Tislelizumab, Bevacizumab or Bevacizumab biosimilar
- Where
- 64 sites in United States, Australia and 2 more
- Volunteers
- 113 people
- Sponsor
- BeiGene
Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
- Conditions
- Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
- Trial name
- NCT05828589
- Testing
- BGB-21447
- Where
- 28 sites in United States, Australia and 2 more
- Volunteers
- 51 people
- Sponsor
- BeOne Medicines
Advanced Solid Tumor
A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with…
- Trial name
- NCT06625593
- Testing
- BG-C137, Anticancer Agents
- Where
- 52 sites in United States, Australia and 2 more
- Volunteers
- 168 people
- Sponsor
- BeOne Medicines
Chronic Lymphocytic Leukemia
A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
The purpose of this study is to support the registration plan of sonrotoclax plus zanubrutinib treatment in participants with previously untreated chronic lymphocytic leukemia (CLL).
- Trial name
- NCT06637501
- Testing
- Sonrotoclax, Zanubrutinib
- Where
- 32 sites in United States, Brazil and 4 more
- Volunteers
- 94 people
- Sponsor
- BeOne Medicines
Metastatic Solid Tumors, Advanced Non-squamous Non-small-cell Lung Cancer
A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification
This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as…
- Conditions
- Metastatic Solid Tumors, Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Colorectal Cancer, Advanced Pancreatic Ductal Adenocarcinoma
- Trial name
- NCT06585488
- Testing
- BGB-53038, Tislelizumab, Cetuximab
- Where
- 17 sites in United States, Australia and 3 more
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
CLL / SLL
Zanubrutinib Induction Followed by Delayed Fixed-Duration Combination With Sonrotoclax for CLL/SLL：Stop Trial 2.0
The goal of this clinical trial is to learn if zanubrutinib induction followed by delayed fixed-duration combination with sonrotoclax works to treat previously untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic…
- Trial name
- ZS (NCT07682415)
- Testing
- 12 cycles of zanubrutinib followed by 12 cycles of zanubrutinib in combination with sonrotoclax, zanubrutinib maintenance until disease progression
- Where
- 7 sites in China
- Volunteers
- 60 people
- Sponsor
- Yi Shuhua
Chronic Lymphocytic Leukemia
A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
The goal of this clinical research study is to learn if the combination of zanubrutinib, sonrotoclax, and obinutuzumab can help to control previously untreated CLL/SLL.
- Trial name
- NCT07674810
- Testing
- Zanubrutinib, Obinutuzumab, Sonrotoclax
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- M.D. Anderson Cancer Center
Extensive Stage Small Cell Lung Cancer
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
- Trial name
- DeLLphi-308 (NCT06598306)
- Testing
- Tarlatamab
- Where
- 31 sites in United States, Australia and 8 more
- Volunteers
- 220 people
- Sponsor
- Amgen
Advanced Solid Tumor
BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors
The primary objective of this study is to assess the safety and tolerability of BGB-15025 alone and in combination with tislelizumab; and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and…
- Trial name
- NCT04649385
- Testing
- BGB-15025, Tislelizumab, Carboplatin
- Where
- 20 sites in United States, Australia and 3 more
- Volunteers
- 157 people
- Sponsor
- BeiGene
Urothelial Carcinoma
Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab + either cisplatin or carboplatin + gemcitabine versus placebo+ either cisplatin or…
- Trial name
- NCT03967977
- Testing
- Tislelizumab, Cisplatin, Gemcitabine Hydrochloride
- Where
- 46 sites in China, Taiwan
- Volunteers
- 420 people
- Sponsor
- BeiGene
Mature B-Cell Malignancies
Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies
The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule…
- Trial name
- NCT04277637
- Testing
- Sonrotoclax, Zanubrutinib, Obinutuzumab
- Where
- 43 sites in United States, Australia and 5 more
- Volunteers
- 437 people
- Sponsor
- BeOne Medicines
Healthy Participants, Healthy Subjects
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases
This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different…
- Conditions
- Healthy Participants, Healthy Subjects, Healthy Volunteers, Autoimmune Diseases
- Trial name
- NCT06342713
- Testing
- BGB-45035
- Where
- 13 sites in Australia, China and 1 more
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- BeiGene
Advanced Solid Tumor, Metastatic Solid Tumor
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4)…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Hormone-receptor-positive Breast Cancer, Breast Cancer
- Trial name
- NCT06253195
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 7 sites in China
- Volunteers
- 33 people
- Sponsor
- BeOne Medicines
Advanced Solid Tumor
A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid…
- Trial name
- NCT06422520
- Testing
- BGB-C354, Tislelizumab
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 63 people
- Sponsor
- BeOne Medicines