Advanced Solid Tumor Clinical Trial
Official title:
A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors
Verified date | January 2024 |
Source | BeiGene |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study includes 2 parts. Part 1 is a safety run-in stage and part 2 is to assess the efficacy and safety of tislelizumab in combination with lenvatinib
Status | Active, not recruiting |
Enrollment | 65 |
Est. completion date | July 2024 |
Est. primary completion date | October 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key inclusion criteria: 1. Signed informed consent form (ICF) and able to comply with study requirements 2. Histologically and/or cytologically confirmed advanced solid tumor types such as one of following: Non-small cell lung cancer (NSCLC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Colorectal Cancer (UC), or Renal Cell Carcinoma (RCC). 3. At least 1 measurable lesion per RECIST version 1.1 4. Tumor tissue (approximately 10 unstained slides) for central laboratory assessment of pd-l1 status for the NSCLC cohort during the screening period, and for retrospective analysis of other exploratory biomarkers related to response and resistance for NSCLC, SCCHN, UC, or GC cohorts in a BeiGene designated central or test laboratory. 5. ECOG performance status = 1 Key exclusion criteria: 1. For the NSCLC cohort, active leptomeningeal disease or uncontrolled, untreated brain metastasis will be excluded. For other cohorts than NSCLC, patients with known leptomeningeal disease or brain metastasis will be excluded. 2. Prior therapy with lenvatinib or an anti-pd-1, anti-pd-l1, anti-pd-l2 or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways 3. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc. 4. Inability to swallow capsules or disease/procedure significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction 5. Have clinically significant bleeding (such as ctcae = grade 2) within 21 days before first dose NOTE: OTHER PROTOCOL DEFINED INCLUSION/EXCLUSION CRITERIA MAY APPLY |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
China | Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing |
China | Beijing Luhe Hospital | Beijing | Beijing |
China | Peking University First Hospital | Beijing | Beijing |
China | Hunan Cancer Hospital | Changsha | Hunan |
China | Chongqing University Cancer Hospital | Chongqing | Chongqing |
China | Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
China | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang |
China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
China | The Second Hospital of Anhui Medical Hospital | Hefei | Anhui |
China | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
China | Jiangsu Cancer Hospital | Nanjing | Jiangsu |
China | Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu |
China | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi |
China | Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
BeiGene |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1: Percentage of Participants Reporting One or More Dose-Limiting Toxicities (DLTs) Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 28 days in Part 1 | ||
Primary | Part 1: Number of Participants with Clinically Significant physical examinations, electrocardiograms (ECGs), and laboratory assessments | Up to 28 days in Part 1 | ||
Primary | Part 2: Overall response rate (ORR) | Defined as the proportion of participants who achieved complete response (CR), or partial response (PR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | up to approximately 3.5 years | |
Secondary | Progression-Free Survival (PFS) | PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first | up to approximately 3.5 years | |
Secondary | Duration Of Response (DOR) | DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death | up to approximately 3.5 years | |
Secondary | Disease Control Rate (DCR) | DCR is defined as the percentage of participants who have shown Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as the best overall response in accordance with the RECIST version 1.1 criteria. | up to approximately 3.5 years | |
Secondary | Overall Survival (OS) | OS defined as the time from start of treatment to the date of death due to any cause | up to approximately 3.5 years | |
Secondary | Part 2: Proportion of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | up to approximately 3.5 years |
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