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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Planned doses will be administered intravenously.
Planned doses will be administered via subcutaneous injection.
Chemotherapy Doublet 1: Cisplatin/carboplatin + pemetrexed. Chemotherapy Doublet 2: Carboplatin + paclitaxel/nab-paclitaxel. Choice of histology-based induction chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC
Time frame: Up to approximately 3.5 months
Part 1 and 2: Concentration at the end of dosing interval (Ctrough) of Tislelizumab SC
Time frame: Up to approximately 3.5 months
Part 1: Bioavailability of Tislelizumab SC
Time frame: Up to approximately 2 months
Part 2: Maximum observed plasma concentration (Cmax) of Tislelizumab SC
Time frame: Up to approximately 3.5 months
Part 2: Accumulation ratio (Rac) of Tislelizumab SC
Time frame: Up to approximately 3.5 months
Part 2: Elimination half-life (t1/2) of Tislelizumab SC
Time frame: Up to approximately 3.5 months
Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs and laboratory abnormalities, reported during the AE reporting period and characterized by type, frequency, severity (as graded by National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v5.0\]), timing, seriousness, and relationship to study therapy.
Time frame: Up to approximately 27 months
Part 1: Maximum observed concentration (Cmax) of Tislelizumab SC
Time frame: Up to approximately 2 months
Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Jining No Peoples Hospital East Branch
Jining, Shandong, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
...and 5 more locations
Number of participants with AEs and SAEs and laboratory abnormalities, reported during the AE reporting period and characterized by type, frequency, severity (as graded by NCI-CTCAE v5.0), timing, seriousness, and relationship to study therapy.
Time frame: Up to approximately 27 months
Part 1 and 2: Number of Participants with Anti-Tislelizumab Antibodies
Time frame: Up to 25 months
Part 2: Overall Response Rate (ORR) of Tislelizumab SC
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined from tumor assessments by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Time frame: Up to approximately 27 months
Part 2: Duration of Response (DOR) of Tislelizumab SC
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death due to any cause, whichever occurs first as assessed by the investigator.
Time frame: Up to approximately 27 months
Part 2: Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to approximately 27 months