NCT05609370Active, not recruitingPhase 1/2
A Study Investigating the Efficacy and Safety of Alcestobart (LBL-007) Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer
A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
This is a Phase 1b/2 study to investigate the efficacy and safety of alcestobart (LBL-007) plus tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine, and alcestobart in combination with bevacizumab plus fluoropyrimidine versus bevacizumab plus fluoropyrimidine to participants with colorectal cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 113 (actual)
- First submitted
- 20 Oct 2022
- Start date
- 29 Jan 2023
- Primary completion date
- 23 May 2025
- Lead sponsor
- BeiGene
- Diseases
- Colorectal cancer
- NCT number
- NCT05609370
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 113
- From 29 Jan 2023 to the primary completion date, 23 May 2025
- 64 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Progressive disease occurred less than 6 months from completion of any prior neoadjuvant therapy (ie, chemotherapy with or without radiotherapy) or adjuvant therapy (ie, chemotherapy with or without radiotherapy), whichever occurred later
- Any prior therapy targeting T-cell stimulation or checkpoint pathways
Other illness
- Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible
Lab values
- Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment
Other
- Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E mutations
- Have locally or centrally confirmed microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method
- Note: Other protocol defined criteria may apply.
Who the study is looking for
- Participant must have measurable disease as defined per RECIST((Response Evaluation Criteria in Solid Tumors) version 1.1
- Has a histologically confirmed colorectal adenocarcinoma with metastatic or unresectable disease (Stage IV as defined by American Joint Committee on Cancer \[AJCC\] 8th edition)
- No prior systemic therapy for colorectal cancer (CRC) in the metastatic setting except for the induction treatment of first-line therapy. Note: Local regional treatment performed during induction systemic treatment is allowed
- Participants who have completed the first-line induction treatment, with an overall response of stable disease or better. The duration of induction treatment should be completed within approximately 6 months. The first dose of study treatment needs to occur within 2 weeks (for 2-week regimen) or 3 weeks (for 3-week regimen) to 6 weeks after Day 1 of the last cycle of induction therapy
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (64)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pindara Private Hospital Coordinator of this site? Confirm its status | Benowa | Australia | Unknown status |
| Blacktown Cancer and Haematology Centre Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| St John of God Murdoch Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| One Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Orange Health Service (Central West Cancer Care Centre) Coordinator of this site? Confirm its status | Orange | Australia | Unknown status |
| Riverina Cancer Care Centre Coordinator of this site? Confirm its status | Wagga Wagga | Australia | Unknown status |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| Beijing Tsinghua Changgung Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Zhujiang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jining No1 Peoples Hospital West Branch Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| Karamay Central Hospital of Xinjiang Coordinator of this site? Confirm its status | Karamay | China | Unknown status |
| Linyi Peoples Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| Nantong First Peoples Hospital Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Quanzhou First Affliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Quanzhou | China | Unknown status |
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai East Hospital Branch Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| the First Affiliated Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
| Shanxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Union Medical Center (Nankai University Affiliated Hospital) Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The Xinjiang Uygur Autonomous Region Peoples Hospital Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Pan American Oncology Trials, Llc Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| University of New Mexico Comprehensive Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Alaska Oncology and Hematology LLC Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| St. Vincent Frontier Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| Helios Clinical Research Coordinator of this site? Confirm its status | Cerritos | United States | Unknown status |
| Pontchartrain Cancer Center Coordinator of this site? Confirm its status | Covington | United States | Unknown status |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Duke Cancer Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Baptist MD Anderson Cancer Center Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| University of Tennessee Medical Center Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Baptist Health Lexington Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Valkyrie Clinical Trials Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| UCLA Hematologyoncology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Usc Norris Comprehensive Cancer Center (Nccc) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Ochsner Clinic Foundation Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Hoag Memorial Presbyterian Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Cancer Care Specialists Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| UT Health San Antonio Mays Cancer Center Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Cancer Care Northwest Coordinator of this site? Confirm its status | Spokane Valley | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| MultiCare Health System Institute for Research and Innovation Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Kaiser Permanente Northern California Coordinator of this site? Confirm its status | Vallejo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.