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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
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

Full criteria on ClinicalTrials.gov

Sites (64)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pindara Private Hospital
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BenowaAustraliaUnknown status
Blacktown Cancer and Haematology Centre
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BlacktownAustraliaUnknown status
Monash Health
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ClaytonAustraliaUnknown status
The Alfred Hospital
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MelbourneAustraliaUnknown status
St John of God Murdoch
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MurdochAustraliaUnknown status
One Clinical Research
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NedlandsAustraliaUnknown status
Orange Health Service (Central West Cancer Care Centre)
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OrangeAustraliaUnknown status
Riverina Cancer Care Centre
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Wagga WaggaAustraliaUnknown status
Calvary Mater Newcastle
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WaratahAustraliaUnknown status
Beijing Tsinghua Changgung Hospital
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BeijingChinaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
Zhujiang Hospital of Southern Medical University
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GuangzhouChinaUnknown status
The Second Affiliated Hospital of Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The Second Hospital of Anhui Medical University
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HefeiChinaUnknown status
Shandong Cancer Hospital
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JinanChinaUnknown status
Jining No1 Peoples Hospital West Branch
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JiningChinaUnknown status
Karamay Central Hospital of Xinjiang
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KaramayChinaUnknown status
Linyi Peoples Hospital
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LinyiChinaUnknown status
Nantong First Peoples Hospital
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NantongChinaUnknown status
Quanzhou First Affliated Hospital of Fujian Medical University
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QuanzhouChinaUnknown status
Renji Hospital Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaUnknown status
Shanghai East Hospital Branch Hospital
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ShanghaiChinaUnknown status
the First Affiliated Hospital of Shantou University Medical College
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ShantouChinaUnknown status
Shanxi Provincial Cancer Hospital
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TaiyuanChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
Tianjin Union Medical Center (Nankai University Affiliated Hospital)
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TianjinChinaUnknown status
The Xinjiang Uygur Autonomous Region Peoples Hospital
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ÜrümqiChinaUnknown status
Hubei Cancer Hospital
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WuhanChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Pan American Oncology Trials, Llc
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Rio PiedrasPuerto RicoUnknown status
University of New Mexico Comprehensive Cancer Center
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AlbuquerqueUnited StatesUnknown status
Alaska Oncology and Hematology LLC
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AnchorageUnited StatesUnknown status
St. Vincent Frontier Cancer Center
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BillingsUnited StatesUnknown status
Helios Clinical Research
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CerritosUnited StatesUnknown status
Pontchartrain Cancer Center
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CovingtonUnited StatesUnknown status
UT Southwestern Medical Center
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DallasUnited StatesUnknown status
Duke Cancer Center
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DurhamUnited StatesUnknown status
Virginia Cancer Specialists
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FairfaxUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology
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Fort WayneUnited StatesUnknown status
Banner MD Anderson Cancer Center
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GilbertUnited StatesUnknown status
Baptist MD Anderson Cancer Center
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JacksonvilleUnited StatesUnknown status
University of Tennessee Medical Center
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KnoxvilleUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada
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Las VegasUnited StatesUnknown status
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesUnknown status
Baptist Health Lexington
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LexingtonUnited StatesUnknown status
Valkyrie Clinical Trials
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Los AngelesUnited StatesUnknown status
UCLA Hematologyoncology
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Los AngelesUnited StatesUnknown status
Usc Norris Comprehensive Cancer Center (Nccc)
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Los AngelesUnited StatesUnknown status
Norton Cancer Institute
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LouisvilleUnited StatesUnknown status
Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital
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MineolaUnited StatesUnknown status
Ochsner Clinic Foundation
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New OrleansUnited StatesUnknown status
Hoag Memorial Presbyterian
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Newport BeachUnited StatesUnknown status
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
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New YorkUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Cancer Care Specialists
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RenoUnited StatesUnknown status
UT Health San Antonio Mays Cancer Center
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San AntonioUnited StatesUnknown status
Cancer Care Northwest
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Spokane ValleyUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
MultiCare Health System Institute for Research and Innovation
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TacomaUnited StatesUnknown status
Kaiser Permanente Northern California
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VallejoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.