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
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Leucovorin, Oxaliplatin, Tislelizumab, 5-Fluorouracil
Metastatic Esophageal Squamous Cell Carcinoma, Advanced Esophageal Squamous Cell Carcinoma
Phase II
Not Yet Recruiting
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
Jul 22, 2026
Dexamethasone, Azacitidine, Sonrotoclax, Inotuzumab Ozogamicin, Bgb-11417
Pediatric All, Relapsed, Pediatric All, Pediatric All, B Cell, Pediatric Aml, R/R B-Cell All, Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, R/R Aml, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Pediatric Cancer, B-Cell Acute Lymphoblastic Leukemia
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
Urothelial Carcinoma, Triple Negative Breast Cancer, Head And Neck Squamous Cell Carcinoma, Hepatocellular 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
Abemaciclib, Letrozole, Ribociclib, Palbociclib, Bgb-43395
Hr+/Her2- Breast Cancer
Phase III
Recruiting
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
Mar 20, 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: Cetuximab, Tislelizumab, Bg-85738, Leucovorin, Oxaliplatin, Tislelizumab, 5-Fluorouracil, Dexamethasone, Azacitidine, Sonrotoclax, Inotuzumab Ozogamicin, Bgb-11417. These drug candidates are in various stages of clinical development as the company works toward FDA approval.