Clinical trials: sponsored by BeOne Medicines
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment…
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, Pediatric Cancer
- Trial name
- NCT07770698
- Testing
- sonrotoclax, Azacitidine, Inotuzumab ozogamicin
- Volunteers
- 30 people
- Sponsor
- BeOne Medicines
Relapsed/Refractory Multiple Myeloma
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
The purpose of this study is to assess the safety, tolerability, and efficacy of sonrotoclax as monotherapy and in various combinations in patients with relapsed/refractory (R/R) multiple myeloma (MM) and chromosomal…
- Trial name
- NCT04973605
- Testing
- Sonrotoclax, Dexamethasone, Carfilzomib
- Where
- 74 sites in United States, Australia and 11 more
- Volunteers
- 246 people
- Sponsor
- BeOne Medicines
Non-small Cell Lung Cancer Metastatic
Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden
AIO-TRK/YMO-0425 (High Five) is a phase III, open-label randomized-controlled, multicenter study to evaluate the progression-free survival by the addition of platinum-based chemotherapy to immunotherapy (IO) compared to IO…
- Trial name
- High Five (NCT07715396)
- Testing
- Tislelizumab, Tislelizumab Combined With Chemotherapy, Pembrolizumab
- Where
- Germany
- Volunteers
- 230 people
- Sponsor
- AIO-Studien-gGmbH
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
- 4 sites in Japan
- Volunteers
- 30 people
- Sponsor
- BeOne Medicines
Solid Tumor, Advanced Solid Tumor
An Investigational Study of BON-106 in Adults With Advanced or Metastatic Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BON-106 in adults with advanced or metastatic solid tumors.
- Conditions
- Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor
- Trial name
- NCT07893535
- Testing
- BON-106
- Volunteers
- 96 people
- Sponsor
- BeOne Medicines
MSI-H/dMMR Solid Tumors
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high…
- Trial name
- NCT03736889
- Testing
- Tislelizumab (BGB-A317)
- Where
- 29 sites in China
- Volunteers
- 200 people
- Sponsor
- BeiGene
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
- 241 sites in United States, Australia and 14 more
- Volunteers
- 1,056 people
- Sponsor
- BeOne Medicines
Chronic Lymphocytic Leukemia, CLL
A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
- Conditions
- Chronic Lymphocytic Leukemia, CLL, Mantle Cell Lymphoma, MCL
- Trial name
- NCT06697184
- Testing
- Sonrotoclax, Zanubrutinib
- Where
- 22 sites in United States, Australia and 4 more
- Volunteers
- 258 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
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
Healthy Volunteers
A Study to Investigate the Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax in Healthy Adults
The purpose of this study is to evaluate whether blood levels of sonrotoclax after administration of a tablet for oral suspension are similar to those observed with the current sonrotoclax tablet.
- Trial name
- NCT07628881
- Testing
- Sonrotoclax Tablet for Oral Suspension, Sonrotoclax Tablet
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- 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
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
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Tacabrutideg and Sonrotoclax, With Response-Guided Obinutuzumab, for the Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
This phase II trial tests how well tacabrutideg and sonrotoclax, with response-guided addition of obinutuzumab, works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
- Conditions
- Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Small Lymphocytic Lymphoma
- Trial name
- NCT07887061
- Testing
- Tacabrutideg, Sonrotoclax, Obinutuzumab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Fred Hutchinson Cancer Center
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
Non-Small Cell Lung Cancer (NSCLC)
MRD and Imaging Guided Adaptive Neoadjuvant Therapy for Resectable NSCLC
Neoadjuvant immunotherapy combined with platinum-based doublet chemotherapy has been established as the standard of care for driver-gene-negative (EGFR/ALK wild-type) stage II-IIIB non-small cell lung cancer (NSCLC), yielding…
- Trial name
- NCT07885709
- Testing
- PD-1 inhibitor, Carboplatin, Nab-paclitaxel
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Peking University People's Hospital
Gastric Neoplasms, Gastroesophageal Adenocarcinoma
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.
- Conditions
- Gastric Neoplasms, Gastroesophageal Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- HERIZON-GEA-01 (NCT05152147)
- Testing
- Zanidatamab, Tislelizumab, Trastuzumab
- Where
- 227 sites in Argentina, Australia and 31 more
- Volunteers
- 920 people
- Sponsor
- Jazz Pharmaceuticals
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
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
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