Clinical trials: completed, sponsored by BeiGene
HER2-negative Breast Cancer
Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China
This is a Phase 2, open-label, multi-center study of BGB-290 administered orally (PO) twice daily (BID) in adult Chinese patients with advanced HER2(-) breast cancer harboring germline BRCA mutation, which have progressed despite…
- Trial name
- NCT03575065
- Testing
- BGB-290
- Where
- 20 sites in China
- Volunteers
- 88 people
- Sponsor
- BeiGene
Covid19
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in healthy participants
- Trial name
- NCT04532294
- Testing
- BGB DXP593
- Where
- Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- BeiGene
Waldenström's Macroglobulinemia
A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)
This study evaluated the safety, efficacy and clinical benefit of BGB-3111 (zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.
- Trial name
- ASPEN (NCT03053440)
- Testing
- BGB-3111, Ibrutinib
- Where
- 58 sites in United States, Australia and 10 more
- Volunteers
- 201 people
- Sponsor
- BeiGene
Healthy Volunteers
Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults
Study to assess the relative bioavailability of zanubrutinib tablets compared to capsules and to evaluate the effects of food on the pharmacokinetics (PK) of the zanubrutinib tablet.
- Trial name
- NCT05547399
- Testing
- Zanubrutinib
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- BeiGene
Esophageal Squamous Cell Carcinoma, Gastric Carcinoma, Gastroesophageal Junction Carcinoma
BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Carcinoma
This is a Phase 2, multi-cohort study to investigate safety, PK, and preliminary anti-tumor activity of the monoclonal antibody BGB A317 in combination with standard chemotherapy as first-line treatment.
- Trial name
- NCT03469557
- Testing
- Tislelizumab, Cisplatin, 5-FU
- Where
- 6 sites in China
- Volunteers
- 30 people
- Sponsor
- BeiGene
Locally Advanced Lung Cancer; Metastatic Lung Cancer
Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer
This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB-A317 in combination with standard platinum-based chemotherapy in participants with advanced NSCLC or SCLC.
- Trial name
- NCT03432598
- Testing
- Tislelizumab, Paclitaxel, Gemcitabine
- Where
- 7 sites in China
- Volunteers
- 54 people
- Sponsor
- BeiGene
Solid Tumors
The Study of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid Tumor
This study will evaluate the safety, tolerability, pharmacokinetics, food effect, and preliminary antitumor activities of BGB-283 in Chinese subjects with local advanced or metastatic malignant solid tumor.
- Trial name
- NCT03641586
- Testing
- BGB-283
- Where
- China
- Volunteers
- 42 people
- Sponsor
- BeiGene
High-risk Neuroblastoma
Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma
This was an open-label, multi-center, single-arm, Phase 1 study. The purpose of this study was for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in Chinese participants with high-risk…
- Trial name
- NCT05373901
- Testing
- Dinutuximab Beta, 13-cis-Retinoic Acid
- Where
- 3 sites in China
- Volunteers
- 8 people
- Sponsor
- BeiGene
Lymphoma, Leukemia
Zanubrutinib (BGB-3111) in Combination With Tislelizumab (BGB-A317) in Participants With B-cell Malignancies
This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with BGB-A317 in participants with B-cell lymphoid malignancies.
- Trial name
- NCT02795182
- Testing
- Zanubrutinib, Tislelizumab
- Where
- 10 sites in Australia, China
- Volunteers
- 75 people
- Sponsor
- BeiGene
B-cell Malignancies
Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies
This study evaluated the safety, tolerability, pharmacokinetic profile and efficacy of BGB-3111 in participants with B-cell lymphoid malignancies.
- Trial name
- NCT02343120
- Testing
- Zanubrutinib
- Where
- 23 sites in United States, Australia and 4 more
- Volunteers
- 385 people
- Sponsor
- BeiGene
Solid Tumors
The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination With BGB-290 in Participants With Advanced Solid Tumors
This trial studied the safety, pharmacokinetics, and antitumor activity of the anti-programmed cell death 1 (PD-1) monoclonal antibody (mAb) BGB-A317 (tislelizumab) in combination with the poly(adenosine diphosphate ribose)…
- Trial name
- NCT02660034
- Testing
- Tislelizumab, Pamiparib
- Where
- 29 sites in United States, Australia and 4 more
- Volunteers
- 229 people
- Sponsor
- BeiGene
Advanced Cancer
Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors
This study evaluated the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-A317 in participants with advanced tumors.
- Trial name
- NCT02407990
- Testing
- BGB-A317
- Where
- 27 sites in United States, Australia and 3 more
- Volunteers
- 451 people
- Sponsor
- BeiGene
Advanced Solid Tumors
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Pamiparib in Participants With Advanced Cancer
This is an open-label study, in participants with advanced and/or metastatic solid tumors, which consists of 2 parts: a research phase (inpatient) and a treatment phase.
- Trial name
- NCT03991494
- Testing
- [14C]-pamiparib
- Where
- 2 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- BeiGene
Hepatic Insufficiency & Healthy Subjects
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
- Trial name
- NCT03465059
- Testing
- Zanubrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BeiGene
Healthy Volunteers
A Two-Part Phase 1 Study to Investigate the Safety and Tolerability of Supratherapeutic Dose of Zanubrutinib and Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects
A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects
- Trial name
- NCT03432884
- Testing
- BGB-3111, Moxifloxacin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- BeiGene
Healthy Volunteers
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 in Healthy Males
Phase 1 study in healthy subjects to determine the effect of an 8-hour fast from food on the pharmacokinetics of [14C]-BGB-3111.
- Trial name
- NCT04163783
- Testing
- [14C]-BGB-3111, BGB-3111
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- BeiGene
Healthy Subjects
A Pharmacokinetic Study to Assess Drug-drug Interaction Between Zanubrutinib and a Cocktail of Substrates in Healthy Subjects
This study is designed to evaluate the safety and pharmacokinetic interaction of effects of multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450 (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and…
- Trial name
- NCT03561298
- Testing
- BGB-3111 and Drug Cocktail
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- BeiGene
Healthy Volunteers: Asian, Non-Asian
Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects
Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111
- Trial name
- NCT03301181
- Testing
- BGB-3111 (Arm A), Rifampin, BGB-3111 (Arm B)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- BeiGene