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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Keywords: lung cancer
non-small cell lung cancer
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* Able to sign a written consent form, understand, and agree to comply with requirements of the study.
* Documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.
* No prior systemic treatment for advanced or metastatic NSCLC, including but not limited to chemotherapy or targeted therapy.
* At least one measurable lesion as assessed by RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) PS ≤ 1.
* Adequate organ function as indicated by laboratory tests.

Exclusion Criteria:

* Participants diagnosed with NSCLC that harbor a driver mutation (eg, EGFR-sensitizing mutation, ALK fusion oncogene, and BRAF V600E mutation or ROS1 mutation).
* Participant has received any Chinese herbal medicine or Chinese patent medicines used to control cancer within 14 days before first dose of study drug.
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
* Active autoimmune diseases or history of autoimmune diseases that may relapse.
* Any cancer ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix or breast).
* Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC
timeFrame: Up to approximately 3.5 months
measure: Part 1 and 2: Concentration at the end of dosing interval (Ctrough) of Tislelizumab SC
timeFrame: Up to approximately 3.5 months
measure: Part 1: Bioavailability of Tislelizumab SC
timeFrame: Up to approximately 2 months
measure: Part 2: Maximum observed plasma concentration (Cmax) of Tislelizumab SC
timeFrame: Up to approximately 3.5 months
measure: Part 2: Accumulation ratio (Rac) of Tislelizumab SC
timeFrame: Up to approximately 3.5 months
measure: Part 2: Elimination half-life (t1/2) of Tislelizumab SC
timeFrame: Up to approximately 3.5 months
measure: Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to approximately 27 months
Secondary outcomes:
measure: Part 1: Maximum observed concentration (Cmax) of Tislelizumab SC
timeFrame: Up to approximately 2 months
measure: Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to approximately 27 months
measure: Part 1 and 2: Number of Participants with Anti-Tislelizumab Antibodies
timeFrame: Up to 25 months
measure: Part 2: Overall Response Rate (ORR) of Tislelizumab SC
timeFrame: Up to approximately 27 months
measure: Part 2: Duration of Response (DOR) of Tislelizumab SC
timeFrame: Up to approximately 27 months
measure: Part 2: Progression-Free Survival (PFS)
timeFrame: Up to approximately 27 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Jining
country: China
facility: Jining No Peoples Hospital East Branch
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Deyang
country: China
facility: Deyangs People Hospital
state: Sichuan
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Tbilisi
country: Georgia
facility: Arensia Exploratory Medicine Llc
city: Chisinau
country: Moldova, Republic of
facility: The Institute of Oncology, Arensia Exploratory Medicine
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: