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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091943
• Other study ID #: BGB-A317-103
• Secondary ID: CTR20233814
• Status: Recruiting
• Phase: Phase 1
• Start date: November 16, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: BeiGene
• Contact: Study Director
• Phone: 1.877.828.5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 31, 2026
• Est. primary completion date: July 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Tislelizumab IV
Planned doses will be administered intravenously.
• Tislelizumab SC
Planned doses will be administered via subcutaneous injection.
• Histology-Based Chemotherapy Doublet
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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peoples Hospital of Deyang City	Deyang	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Mengchao Hepatobiliary Hospital of Fujian Medical University	Fuzhou	Fujian
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Jining No Peoples Hospital	Jining	Shandong
China	The First Affiliated Hospital of Nanchang University Branch Donghu	Nanchang	Jiangxi
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	Henan Cancer Hospital	Zhengzhou	Henan
Georgia	Arensia Exploratory Medicine Llc	Tbilisi
Moldova, Republic of	The Institute of Oncology, Arensia Exploratory Medicine	Chisinau

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

China,  Georgia,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC		Up to approximately 3.5 months
Primary	Part 1 and 2: Concentration at the end of dosing interval (Ctrough) of Tislelizumab SC		Up to approximately 3.5 months
Primary	Part 1: Bioavailability of Tislelizumab SC		Up to approximately 2 months
Primary	Part 2: Maximum observed plasma concentration (Cmax) of Tislelizumab SC		Up to approximately 3.5 months
Primary	Part 2: Accumulation ratio (Rac) of Tislelizumab SC		Up to approximately 3.5 months
Primary	Part 2: Elimination half-life (t1/2) of Tislelizumab SC		Up to approximately 3.5 months
Primary	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.	Up to approximately 27 months
Secondary	Part 1: Maximum observed concentration (Cmax) of Tislelizumab SC		Up to approximately 2 months
Secondary	Part 1: 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 NCI-CTCAE v5.0), timing, seriousness, and relationship to study therapy.	Up to approximately 27 months
Secondary	Part 1 and 2: Number of Participants with Anti-Tislelizumab Antibodies		Up to 25 months
Secondary	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).	Up to approximately 27 months
Secondary	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.	Up to approximately 27 months
Secondary	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.	Up to approximately 27 months