Locally Advanced and Metastatic Solid Tumors Clinical Trial
Official title:
Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
| Verified date | February 2024 |
| Source | BeiGene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objectives of this study are : to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as Ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion cohort
| Status | Active, not recruiting |
| Enrollment | 449 |
| Est. completion date | August 2024 |
| Est. primary completion date | August 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: Phase 1 Key Inclusion Criteria 1. Has Eastern Cooperative Oncology Group (ECOG) Performance Status =1. 2. = 1 measurable lesion per RECIST v1.1. 3. Has adequate organ function. 4. phase 1- Patients with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for which treatment is not available, not tolerated or refused. Phase 1b Key Inclusion Criteria 1. Signed informed consent form (ICF) and able to comply with study requirements. 2. Age = 18 years (or the legal age of consent) at the time the ICF is signed. 3. Histologically or cytologically confirmed tumor types in the following disease cohorts: Cohort 1: stage IV squamous NSCLC Cohort 2: stage IV non-squamous NSCLC Cohort 3: stage IV squamous or non-squamous NSCLC with PD-L1 positive. Cohort 4: extensive-stage SCLC Cohort 5: stage IIIB, IIIC or IV NSCLC Cohort 6: stage IV ESCC Cohort 7: stage IV EAC Cohort 8: recurrent or metastatic HNSCC incurable by local therapies Cohort 9: stage IV G/GEJ adenocarcinoma. Cohort 10: stage IV squamous or non-squamous NSCLC with PD-L1 positive. 4. ECOG Performance Status = 1 5. Adequate organ function 6. Willing to use highly effective method of birth control Phase 1 Key Exclusion Criteria: 1. Active brain or leptomeningeal metastasis. 2. Active autoimmune diseases or history of autoimmune diseases that may relapse. 3. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for patients with hepatocellular carcinoma). 4. Concurrent participation in another therapeutic clinical trial. 5. Received prior therapies targeting TIGIT. Phase 1b Key Exclusion Criteria: 1. Patients with any prior therapy for recurrent/metastatic disease. 2. Non-squamous NSCLC patients with sensitizing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion. 3. Gastric cancer patients with squamous or with positive HER2 expression. 4. Prior therapy with any drug specifically targeting T-cell co-stimulation or checkpoint pathways. (anti-PD(L)1 exception for Cohort 5). 5. Active leptomeningeal disease or uncontrolled brain metastasis. 6. Active autoimmune diseases or history of autoimmune diseases that may relapse. 7. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for patients with hepatocellular carcinoma). 8. Concurrent participation in another therapeutic clinical study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | St Vincents Hospital | Fitzroy | Victoria |
| China | Beijing Cancer Hospital | Beijing | Beijing |
| China | Beijing Tongren Hospital, Cmu | Beijing | Beijing |
| China | Jilin Cancer Hospital | Changchun | Jilin |
| China | Sichuan Cancer Hospital and Institute | Chengdu | Sichuan |
| China | Chongqing Cancer Hospital | Chongqing | Chongqing |
| China | Fujian Cancer Hospital | Fuzhou | Fujian |
| China | Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong |
| China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
| China | Jinan Central Hospital | Jinan | Shandong |
| China | Shanghai Chest Hospital | Shanghai | Shanghai |
| China | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin |
| China | Tianjin Medical University General Hospital | Tianjin | Tianjin |
| China | Weifang Peoples Hospital | Weifang | Shandong |
| China | Hubei Cancer Hospital | Wuhan | Hubei |
| China | Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
| China | The First Affiliated Hospital of Xian Jiaotong University | Xian | Shaanxi |
| China | Henan Cancer Hospital | Zhengzhou | Henan |
| Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | Chung Shan Medical University Hospital | Taichung | |
| Taiwan | Veterans General Hospital Taichung | Taichung | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| Taiwan | Taipei Tzu Chi Hospital | Taipei | |
| Taiwan | Linkou Chang Gung Memorial Hospital | Taoyuan | |
| United States | University of Kansas Medical Center Research Institute | Kansas City | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| BeiGene |
United States, Australia, China, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Phase 1 Dose Escalation - Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) | Up to 28 Days in Cycle 1 | ||
| Primary | Phase 1 Dose Escalation - Number of participants experiencing Serious Adverse Events (SAEs) | Up to 1.5 years | ||
| Primary | Phase 1 Dose Escalation - Recommended Phase Ib dose (RP2D) of ociperlimab in combination with tislelizumab | Up to 1.5 years | ||
| Primary | Phase 1b Dose Confirmation - Anti-tumor activity of ociperlimab in combination with tislelizumab in patients with select advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using RECIST v. 1.1. | Up to 1.5 years | ||
| Secondary | Duration of response (DOR) | Duration of response (DOR) will be determined from investigator derived tumor assessments per RECIST v. 1.1. | Up to 3 years | |
| Secondary | Disease control rate (DCR) | Disease control rate (DCR) will be determined from investigator derived tumor assessments per RECIST v. 1.1. | Up to 3 years | |
| Secondary | Progression free survival | Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1. | Up to 3 years | |
| Secondary | Immunogenicity as assessed by the presence of anti-drug antibodies | Up to 3 years |