Product Description
BGB-A445 is an agonistic antibody that does not block the OX40-OX40L interaction.
Mechanisms of Action: OX40 Agonist
Novel Mechanism: Yes
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: BeOne Medicines
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, Canada, China, France, Georgia, Italy, Japan, Malaysia, Moldova, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, United States, Unknown Location
Active Clinical Trial Count: 8
Recent & Upcoming Milestones
- Clinical Outcomes Expected - BeOne Medicines announced they will present P1 Transitional Cell Carcinoma|Renal Cell Carcinoma|Melanoma results on 2026-10-24 for Gimistotug
- Clinical Outcomes Reported - BeiGene announced they will present P2 Non-Small-Cell Lung Cancer results in YE24 for Gimistotug
- Clinical Outcomes Reported - BeiGene announced they will present P1 Oncology Solid Tumor Unspecified results in YE24 for Gimistotug
Highest Development Phases
Phase 3: Other
Phase 2: Melanoma|Non-Small-Cell Lung Cancer|Renal Cell Carcinoma|Transitional Cell Carcinoma
Phase 1: Head and Neck Cancer|Nasopharyngeal Cancer|Squamous Cell Carcinoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04215978 |
BGB-A317-A445-101 | P1 |
Completed |
Non-Small-Cell Lung Cancer|Head and Neck Cancer|Squamous Cell Carcinoma|Nasopharyngeal Cancer |
2025-01-24 |
2026-04-01 |
||
NCT05635708 |
Master Protocol | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2025-12-31 |
12% |
2025-12-16 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05661955 |
BGB-A317-A445-201 | P2 |
Active, not recruiting |
Renal Cell Carcinoma|Melanoma|Transitional Cell Carcinoma |
2025-05-27 |
12% |
2025-11-18 |
|
NCT04164199 |
BGB-A317-290-LTE1 | P3 |
Completed |
Other |
2026-05-23 |
14% |
2026-06-04 |
Primary Endpoints |
CTR20233070 |
CTR20233070 | P2 |
Completed |
Non-Small-Cell Lung Cancer |
2024-12-31 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT06029127 |
BGB-LC-203 | P2 |
Completed |
Non-Small-Cell Lung Cancer |
2024-12-31 |
2026-01-06 |
Primary Endpoints|Treatments |
|
CTR20230892 |
CTR20230892 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
None |
12% |
2025-04-29 |
Patient Enrollment|Treatments|Trial Status |
2022-502738-18-00 |
BGB-LC-201 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer |
2025-07-26 |
12% |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
05/22/2025 |
News Article |
BeiGene Presents Pioneering Cancer Research at ASCO 2025 – Redefining Treatment Across Hematology and Solid Tumors |
|
08/07/2024 |
News Article |
BeiGene Enters Next Phase of Global Growth with Announcement of Second Quarter 2024 Financial Results and Corporate Updates |
|
05/08/2024 |
News Article |
BeiGene Reports First Quarter 2024 Financial Results and Business Updates |
|
08/02/2023 |
News Article |
BeiGene Accelerates Global Momentum with Strong Second Quarter 2023 Financial Results |