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Tislelizumab SC / Tislelizumab IV / Histology-Based Chemotherapy Doublet · Phase 1 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 registry record for a completed but not-yet-reported bioavailability study of subcutaneous tislelizumab in advanced NSCLC. The study evaluates pharmacokinetic properties (AUC, Cmax, Ctrough, half-life, accumulation) and safety over approximately 3.5 months of observation, with no clinical efficacy endpoints. Results are not yet published in this registry record.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Non-small Cell Lung Cancer; age from 18 Years. Intervention: Part 1: Dose/Injection Site Exploration; Part 2: Dose Expansion. Compared with: Histology-based chemotherapy doublet; IV tislelizumab (as reference for SC bioavailability comparison). n = 62. 15 sites: China, Georgia, Moldova.
This is a Phase 1 registry record for a completed but not-yet-reported bioavailability study of subcutaneous tislelizumab in advanced NSCLC. The study evaluates pharmacokinetic properties (AUC, Cmax, Ctrough, half-life, accumulation) and safety over approximately 3.5 months of observation, with no clinical efficacy endpoints. Results are not yet published in this registry record.
Primary outcomes are pharmacokinetic and safety endpoints only; no efficacy, response rate, or survival data are planned.
This registry record provides design information only. Once results are available, clinicians will be able to assess whether subcutaneous tislelizumab has acceptable bioavailability and tolerability to support further development as an alternative to intravenous administration in lung cancer treatment.
Phase 1 bioavailability study with completed recruitment but no results posted; addresses pharmacokinetic endpoints and safety in a small population with advanced lung cancer.
As stated by the source record.
Quoted from the source exactly as published.
This registry record provides design information only. Once results are available, clinicians will be able to assess whether subcutaneous tislelizumab has acceptable bioavailability and tolerability to support further development as an alternative to intravenous administration in lung cancer treatment.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06091943). This is a study registration, not published results. Lead sponsor: BeiGene. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 62 participants (ACTUAL). Conditions: Non-small Cell Lung Cancer. Interventions: DRUG: Tislelizumab IV; DRUG: Tislelizumab SC; DRUG: Histology-Based Chemotherapy Doublet. Primary outcome measures: Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC , Up to approximately 3.5 months; Part 1 and 2: Concentration at the end of dosing interval (Ctrough) of Tislelizumab SC , Up to approximately 3.5 months; Part 1: Bioavailability of Tislelizumab SC , Up to approximately 2 months; Part 2: Maximum observed plasma concentration (Cmax) of Tislelizumab SC , Up to approximately 3.5 months; Part 2: Accumulation ratio (Rac) of Tislelizumab SC , Up to approximately 3.5 months; Part 2: Elimination half-life (t1/2) of Tislelizumab SC , Up to approximately 3.5 months; Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) , Up to approximately 27 months. 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).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.