Trials / Completed
CompletedNCT04215978
Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of the Anti OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 204 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and tolerability of BGB-A445 alone and in combination with tislelizumab in participants with advanced solid tumors; and to determine the maximum tolerated dose(s) (MTD) or maximum administered dose(s) (MAD) and recommended Phase 2 doses (RP2D) of BGB-A445 alone and in combination with tislelizumab.
Conditions
- Advanced Solid Tumor
- Non Small Cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- Nasopharyngeal Carcinoma (NPC)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BGB-A445 | Administered as specified in the treatment arm |
| DRUG | tislelizumab | Administered as specified in the treatment arm |
Timeline
- Start date
- 2020-01-30
- Primary completion
- 2025-01-24
- Completion
- 2025-01-24
- First posted
- 2020-01-02
- Last updated
- 2025-10-03
Locations
30 sites across 8 countries: United States, Australia, China, Malaysia, New Zealand, South Korea, Taiwan, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04215978. Inclusion in this directory is not an endorsement.