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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05014828
Other study ID # BGB-A317-212
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 18, 2021
Est. completion date July 2024

Study information

Verified date January 2024
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
lenvatinib
Capsules administered orally
Tislelizumab
intravenous (iv) infusion

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

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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