Clinical Trial: NCT06091943
Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | BeiGene |
| Information Provided By: | BeOne Medicines |
| Last Update Posted: | 2026-08-12 |
Study Overview
Brief Summary
This is an open-label, multicenter, Phase 1 clinical study to evaluate the bioavailability of tislelizumab subcutaneous (SC) injection in the first-line treatment of participants with advanced or metastatic non-small cell lung cancer (NSCLC). This clinical study will be divided into 2 parts: dose/injection site exploration (Part 1) and dose expansion (Part 2).
Official Title
Phase 1 Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in the First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Tislelizumab IV
- Drug: Tislelizumab SC
- Drug: Histology-Based Chemotherapy Doublet
Other Study ID Numbers
- BGB-A317-103
- CTR20233814
Start Date (Actual)
2023-11-16
Primary Completion Date (Actual)
2025-07-31
Study Completion Date (Actual)
2026-08-04
Enrollment (Actual)
62
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | BeiGene |
| Information Provided By: | BeOne Medicines |
| Last Update Posted: | 2026-08-12 |
Study Overview
Brief Summary
This is an open-label, multicenter, Phase 1 clinical study to evaluate the bioavailability of tislelizumab subcutaneous (SC) injection in the first-line treatment of participants with advanced or metastatic non-small cell lung cancer (NSCLC). This clinical study will be divided into 2 parts: dose/injection site exploration (Part 1) and dose expansion (Part 2).
Official Title
Phase 1 Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in the First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Tislelizumab IV
- Drug: Tislelizumab SC
- Drug: Histology-Based Chemotherapy Doublet
Other Study ID Numbers
- BGB-A317-103
- CTR20233814
Start Date (Actual)
2023-11-16
Primary Completion Date (Actual)
2025-07-31
Study Completion Date (Actual)
2026-08-04
Enrollment (Actual)
62
Study Type
Interventional
Phase
Phase 1