Cetuximab, Tislelizumab, Bg-85738
Metastatic Solid Tumor, Advanced 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
Bgb-58067 Tablet
Healthy Volunteers
Phase I
Recruiting
A Study to Investigate the Relative Bioavailability of 2 Tablet Formulations and the Effect of Food on the Pharmacokinetics of BGB-58067 in Healthy Participants
Jul 09, 2026
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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, Pediatric All, Relapsed, Pediatric All, Pediatric All, B Cell, Pediatric Aml, R/R B-Cell All, R/R Aml
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
Hepatocellular Carcinoma, Urothelial Carcinoma, Triple Negative Breast Cancer, Head And Neck Squamous Cell Carcinoma, Colorectal Cancer, Renal Cell Carcinoma, Solid Tumor, Endometrial Cancer, Gastroesophageal Adenocarcinoma, Non-small Cell Lung Cancer, Cervical Cancer, Small-cell Lung Cancer
Phase I
Recruiting
A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors
May 29, 2026
Leucovorin, Oxaliplatin, 5-Fluorouracil, Tislelizumab, Capecitabine
Esophageal Squamous Cell Carcinoma, Advanced Unresectable Gastric Adenocarcinoma, Advanced Gastroesophageal Adenocarcinoma
Phase II
Recruiting
A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States
Apr 21, 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 (ONCN) have in its pipeline
ONCN is currently developing the following drugs: Lenvatinib, Sorafenib, Bgb-B2033, Cetuximab, Tislelizumab, Bg-85738, Leucovorin, Oxaliplatin, Tislelizumab, 5-Fluorouracil. These drug candidates are in various stages of clinical development as the company works toward FDA approval.