Sonrotoclax, Bgb-11417
Hepatic Impairment, Healthy Adult Participants
Phase I
Not Yet Recruiting
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
Sep 29, 2026
―
Tacabrutideg, Bgb-16673
Hepatic Impairment, Healthy Adult Participants
Phase I
Not Yet Recruiting
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Sep 29, 2026
―
Cetuximab, Tislelizumab, Bg-85738
Advanced Solid Tumor, Metastatic Solid Tumor, Ras Mutation
Phase I
Recruiting
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
Jul 30, 2026
Dexamethasone, Azacitidine, Sonrotoclax, Inotuzumab Ozogamicin, Bgb-11417
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Pediatric Cancer, B-Cell Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, R/R Aml, Pediatric All, Relapsed, Pediatric All, Pediatric All, B Cell, Pediatric Aml, R/R B-Cell All
Phase I/II
Not Yet Recruiting
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
May 29, 2026
Hh160
Endometrial Cancer, Non-small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Cervical Cancer, Triple Negative Breast Cancer, Head And Neck Squamous Cell Carcinoma, Hepatocellular Carcinoma, Solid Tumor, Gastroesophageal Adenocarcinoma, Small-cell Lung Cancer, Urothelial Carcinoma
Phase I
Recruiting
A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors
May 29, 2026
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does BeOne Medicines (49BA) have in its pipeline
49BA is currently developing the following drugs: Sonrotoclax, Bgb-11417, Tacabrutideg, Bgb-16673, Lenvatinib, Sorafenib, Bgb-B2033. These drug candidates are in various stages of clinical development as the company works toward FDA approval.