Clinical trials: sponsored by BeOne Medicines
Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL)
Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
The study consists of two parts. Part 1 determines the safety and tolerability of sonrotoclax monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of sonrotoclax monotherapy for relapsed or refractory mantle…
- Conditions
- Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma
- Trial name
- NCT05471843
- Testing
- Sonrotoclax
- Where
- 65 sites in United States, Argentina and 12 more
- Volunteers
- 125 people
- Sponsor
- BeOne Medicines
Metastatic Hepatocellular Carcinoma, Local Advanced Hepatocellular Carcinoma
A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BGB-B2033 alone or in combination with tislelizumab, with or without…
- Conditions
- Metastatic Hepatocellular Carcinoma, Local Advanced Hepatocellular Carcinoma, Alpha-fetoprotein (AFP)-Producing Gastric Cancer, Extragonadal Yolk Sac Tumors
- Trial name
- NCT06427941
- Testing
- BGB-B2033, Tislelizumab, Bevacizumab
- Where
- 51 sites in United States, Brazil and 7 more
- Volunteers
- 630 people
- Sponsor
- BeOne Medicines
Advanced Solid Tumor
Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors
This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with other…
- Trial name
- NCT06233942
- Testing
- BG-C9074, Tislelizumab, Bevacizumab
- Where
- 37 sites in United States, Australia and 3 more
- Volunteers
- 308 people
- Sponsor
- BeOne Medicines
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of BGB-11417 in Participants With Myeloid Malignancies
The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and…
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm
- Trial name
- NCT04771130
- Testing
- BGB-11417, Azacitidine, Posaconazole
- Where
- 47 sites in United States, Australia and 8 more
- Volunteers
- 260 people
- Sponsor
- BeOne Medicines
Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent…
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT06756932
- Testing
- BGB-21447, Fulvestrant, BGB-43395
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- BeOne Medicines
Primary Membranous Nephropathy
A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy
The primary objectives of this study are: In Part 1 to evaluate the efficacy of zanubrutinib as measured by proteinuria reduction, and in Part 2 to evaluate the efficacy of zanubrutinib compared with tacrolimus as measured by…
- Trial name
- ALMOND (NCT05707377)
- Testing
- Zanubrutinib, Tacrolimus
- Where
- 45 sites in United States, Brazil and 7 more
- Volunteers
- 178 people
- Sponsor
- BeOne Medicines
B-cell Malignancy, Relapsed Cancer
A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with tacabrutideg in combination with other agents in participants with relapsed or refractory (R/R)…
- Conditions
- B-cell Malignancy, Relapsed Cancer, Refractory Cancer, B-cell Lymphoma
- Trial name
- NCT06634589
- Testing
- Tacabrutideg, Sonrotoclax, Zanubrutinib
- Where
- 49 sites in United States, Australia and 6 more
- Volunteers
- 80 people
- Sponsor
- BeOne Medicines
Advanced Solid Tumor
Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors
This is a first-in-human (FIH), Phase 1a/1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of…
- Trial name
- NCT06598800
- Testing
- Drug: BG-T187, Other Therapeutic Agents
- Where
- 34 sites in United States, Australia and 2 more
- Volunteers
- 153 people
- Sponsor
- BeOne Medicines
Epithelial Ovarian Cancer, Fallopian Tube Cancer
Efficacy and Safety of BG-C9074 With Bevacizumab Compared With Bevacizumab in Adults With Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
The purpose of this study is to evaluate the safety and efficacy of BG-C9074 with bevacizumab (Arm A) versus bevacizumab monotherapy (Arm B) in adults with epithelial ovarian, fallopian tube, or primary peritoneal cancers who…
- Conditions
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- NCT07811271
- Testing
- BG-C9074, Bevacizumab
- Volunteers
- 600 people
- Sponsor
- BeOne Medicines
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants
This is a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of tacabrutideg in adults with chronic spontaneous urticaria (CSU) and in healthy participants.
- Trial name
- NCT07005713
- Testing
- Tacabrutideg
- Where
- 9 sites in China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
B-cell Malignancies
A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib
The purpose of this study is to learn about the long-term safety and effectiveness of zanubrutinib in people with B-cell cancers who took part in an earlier zanubrutinib study.
- Trial name
- NCT04170283
- Testing
- Zanubrutinib, Tislelizumab
- Where
- 153 sites in United States, Australia and 16 more
- Volunteers
- 955 people
- Sponsor
- BeOne Medicines
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors
The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab or chlorambucil plus obinutuzumab)…
- Trial name
- CaDAnCe-303 (NCT06970743)
- Testing
- BGB-16673, Bendamustine, Rituximab
- Where
- 56 sites in China, Taiwan
- Volunteers
- 153 people
- Sponsor
- BeOne Medicines
Advanced Solid Tumor, Metastatic Solid Tumor
A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors.
- Trial name
- NCT06803680
- Testing
- BGB-B455, Chemotherapy
- Where
- 11 sites in United States, Australia and 1 more
- Volunteers
- 90 people
- Sponsor
- BeOne Medicines
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
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
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
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
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
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
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