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

NCT06091943 ↗

Phase 1 Active not recruiting 62 enrolled BeiGene

Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start: 2023-11-16
Primary completion: 2025-07-31
Completion: 2026-07-31

Publications

Liu X, Guan Y, Liu Y, Yu T, Abdrashitov R, Niu Z, Lin X, Ye X, Wang Y, Sahasranaman S, Hanley WD, Budha N. Model-Informed Development of a Subcutaneous Formulation of Tislelizumab: Phase 1 Pharmacokinetics in Patients With Cancer. Clin Transl Sci. 2026 Jul;19(7):e70649. doi: 10.1111/cts.70649.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tislelizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Tislelizumab	Monoclonal antibody	300 mg	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Cisplatin	Other / unclassified	—	Intravenous
Background	Paclitaxel	Small molecule	—	Intravenous
Background	Pemetrexed	Small molecule	—	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications