BeOne Medicines — Biomedical Watch V2

Traitements9programmes

Essais4liés

Publications6liées

SourceDBlocale

Traitements

9

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
BendamustineResearchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy. The goals of this study are to learn: * About the safety of MK-1045 and rituximab, and if people tolerate them when given together * If people who receive MK-1045 and rituximab have the cancer go away * If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)	Cancer	Phase 3	À vérifier	United States, Argentina, Australia, Brazil, Canada, Czechia, Germany, Italy, …	À vérifier
IdelalisibThe purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).	Cancer	Phase 3	Immunomodulation	United States, Argentina, Australia, Brazil, Canada, Czechia, Germany, Italy, …	À vérifier
SonrotoclaxThe purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).	Cancer	Phase 3	À vérifier	United States, Australia, Brazil, Canada, China, Czechia, France, Germany, …	À vérifier
TacabrutidegStudy 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 cohorts)	Cancer	Phase 3	À vérifier	United States, Argentina, Australia, Brazil, Canada, Czechia, Germany, Italy, …	À vérifier
VenetoclaxThis study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.	Cancer	Phase 3	Thérapie cellulaire	United States, Argentina, Australia, Brazil, Canada, Czechia, Germany, Italy, …	À vérifier
VenetoclaxThis study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.	Cancer	Non applicable	Thérapie cellulaire	China	À vérifier
TacabrutidegStudy 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 cohorts)	Cancer	Phase 1/2	À vérifier	United States, Australia, Brazil, Canada, China, France, Georgia, Germany, Italy, Japan, Moldova, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom	À vérifier
SonrotoclaxThe purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).	Cancer	Phase 3	À vérifier	United States, Australia, Brazil, Canada, China, Czechia, France, Germany, Italy, Netherlands, New Zealand, Poland, Romania, South Korea, Spain, Sweden, United Kingdom	À vérifier
TacabrutidegStudy 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 cohorts)	Cancer	Phase 3	Immunomodulation	United States, Argentina, Australia, Brazil, Canada, Czechia, Germany, Italy, Japan, Netherlands, Poland, South Korea, Turkey (Türkiye), United Kingdom	À vérifier

Essais cliniques

4

Molécule	Indication / population	Phase	NCT	Titre	Statut
Tacabrutideg	Cancer	Phase 3	NCT06846671	CaDAnCe-302 — A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors	RECRUITING
Sonrotoclax	Cancer	Phase 3	NCT07277231	A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia	RECRUITING
Tacabrutideg	Cancer	Phase 1/2	NCT05006716	CaDAnCe-101 — A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies	RECRUITING
Venetoclax	Cancer	Non applicable	NCT07762508	A Prospective Single-Arm Study of VABu Conditioning Regimen in Allo-HSCT for Low-Performance or High-Comorbidity AML Patients in CR1	NOT_YET_RECRUITING

Publications

6

Molécule	Indication / population	Titre	Journal	Date
Bendamustine		A dual green chromatographic platform for bioanalytical quantification and pharmacokinetic characterization of the BBD antineoplastic regimen.	Analytica chimica acta
Bendamustine		Comparative pathogenesis and management of orbital/conjunctival and gastric MALT lymphoma: Microbial drivers, molecular mechanisms, and therapeutic implications.	Survey of ophthalmology
Bendamustine		Follicular Lymphoma Arising in an Ileal Neobladder Presenting as a Large Pelvic Mass.	IJU case reports
Venetoclax		Identification of long non-coding RNAs involved in leukemogenesis and venetoclax response in acute myeloid leukemia through functional CRISPR-dCas9 interference screens.	Non-coding RNA research
Venetoclax		Development of highly selective, low-toxicity and orally available Mcl-1 inhibitors based on 3,5-dimethyl-4-sulfonimide-1H-pyrrole scaffold via P2/P3 dual pocket binding optimization.	European journal of medicinal chemistry
Venetoclax		Age-dependent clinical, molecular, and prognostic differences in patients with AML: a retrospective study.	Hematology (Amsterdam, Netherlands)