AzTrials
AzTrials

Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal CancerPhase 1/2NCT05609370

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 1/2 study testing Alcestobart, Tislelizumab and Bevacizumab or Bevacizumab biosimilar in people with Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer, run by BeiGene at 64 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alcestobart, Tislelizumab and Bevacizumab or Bevacizumab biosimilar
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
64 sitesin 4 countries
Study dates
29 Jan 2023to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible
  • 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
  • Participants who have been treated with anti-epidermal growth factor receptor (EGFR) antibody in the induction treatment
  • Any prior therapy targeting T-cell stimulation or checkpoint pathways
  • 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.

Trial locations and contacts

64 sites in 4 countries.

64 sites in 4 countries

United States30 sites

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87102-4517

  • Alaska Oncology and Hematology, Llc

    Anchorage, Alaska, 99508-2974

  • St Vincent Frontier Cancer Center

    Billings, Montana, 59102-6746

  • Helios Clinical Research

    Cerritos, California, 90703

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433-7512

  • Ut Southwestern Medical Center

    Dallas, Texas, 75390-7208

  • Duke Cancer Center

    Durham, North Carolina, 27710-2000

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031-2171

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

  • Banner Md Anderson Cancer Center

    Gilbert, Arizona, 85234-2165

  • Baptist Md Anderson Cancer Center

    Jacksonville, Florida, 32207-8432

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920-1511

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169-3321

  • Baptist Health Lexington

    Lexington, Kentucky, 40503-1466

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536-7001

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067-2011

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California, 90089-1019

  • UCLA Hematologyoncology

    Los Angeles, California, 90095-3075

  • Norton Cancer Institute

    Louisville, Kentucky, 40217-1395

  • Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital

    Mineola, New York, 11501-3957

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121-2429

  • Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health

    New York, New York, 10016-2708

  • Columbia University Medical Center

    New York, New York, 10032

  • Hoag Memorial Presbyterian

    Newport Beach, California, 92663-4162

  • Cancer Care Specialists

    Reno, Nevada, 89511-2250

  • Ut Health San Antonio Mays Cancer Center

    San Antonio, Texas, 78229-4427

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216-1020

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010

  • Multicare Health System Institute For Research and Innovation

    Tacoma, Washington, 98405

  • Kaiser Permanente Northern California

    Vallejo, California, 94589-2441

Other trials in United States

China24 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jining No1 Peoples Hospital West Branch

    Jining, Shandong, 272000

  • Karamay Central Hospital of Xinjiang

    Karamay, Xinjiang, 834009

  • Linyi Peoples Hospital

    Linyi, Shandong, 276000

  • Nantong First Peoples Hospital

    Nantong, Jiangsu, 215124

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Shanghai East Hospital Branch Hospital

    Shanghai, Shanghai Municipality, 200123

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tianjin Union Medical Center (Nankai University Affiliated Hospital)

    Tianjin, Tianjin Municipality, 300121

  • The Xinjiang Uygur Autonomous Region Peoples Hospital

    Ürümqi, Xinjiang, 830001

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

Australia9 sites

  • Pindara Private Hospital

    Benowa, Queensland, QLD 4217

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148

  • Monash Health

    Clayton, Victoria, VIC 3168

  • The Alfred Hospital

    Melbourne, Victoria, VIC 3004

  • St John of God, Murdoch

    Murdoch, Western Australia, WA 6150

  • One Clinical Research

    Nedlands, Western Australia, WA 6009

  • Orange Health Service (Central West Cancer Care Centre)

    Orange, New South Wales, NSW 2800

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales, NSW 2650

  • Calvary Mater Newcastle

    Waratah, New South Wales, NSW 2298

Other trials in Australia

Puerto Rico1 site

  • Pan American Oncology Trials, Llc

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: 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

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.

Being tested
Alcestobart, Tislelizumab, Bevacizumab or Bevacizumab biosimilar, Fluoropyrimidine (FP)
Keywords
Colorectal Cancer, Microsatellite Stable, Mismatch Repair Proficient, Maintenance Therapy
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlcestobartDrug

    Also called LBL-007

    Administered intravenously (IV) at one of the following doses

    • Low dose: 150 mg once every 3 weeks
    • Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks
    • High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks

  • TislelizumabDrug

    Also called BGB-A317

    Administered intravenously at a dose of either 200 mg once every 3 weeks or 300 mg once every 4 weeks.

  • Bevacizumab or Bevacizumab biosimilarDrug

    Administered intravenously at a dose of either 7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks.

  • Fluoropyrimidine (FP)Drug

    Fluoropyrimidine treatment included one of the following:

    • Capecitabine 850 mg/m^2 administered orally twice daily for the first 2 weeks of each 3-week cycle,

    OR

    • 5-fluorouracil (5-FU) 1600 to 2400 mg/m^2 continuous infusion over 46 to 48 hours in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks.
Study groups in NCT05609370
Study groupRoleWhat they receive
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + FluoropyrimidineExperimentalParticipants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
Receives: Drug: Alcestobart; Drug: Tislelizumab; Drug: Bevacizumab or Bevacizumab biosimilar; Drug: Fluoropyrimidine (FP)
Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + FluoropyrimidineExperimentalParticipants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Receives: Drug: Alcestobart; Drug: Tislelizumab; Drug: Bevacizumab or Bevacizumab biosimilar; Drug: Fluoropyrimidine (FP)
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + FluoropyrimidineExperimentalParticipants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Receives: Drug: Alcestobart; Drug: Tislelizumab; Drug: Bevacizumab or Bevacizumab biosimilar; Drug: Fluoropyrimidine (FP)
Phase 2: Arm A:PD-L1-positive: Alcestobart High Dose +Tislelizumab + Bevacizumab +FluoropyrimidineExperimentalPD-L1 (programmed cell death protein ligand-1)-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Receives: Drug: Alcestobart; Drug: Tislelizumab; Drug: Bevacizumab or Bevacizumab biosimilar; Drug: Fluoropyrimidine (FP)
Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + FluoropyrimidineExperimentalPD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Receives: Drug: Alcestobart; Drug: Bevacizumab or Bevacizumab biosimilar; Drug: Fluoropyrimidine (FP)
Phase 2: Arm C: PD-L1-positive: Bevacizumab + FluoropyrimidineActive comparatorPD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Receives: Drug: Bevacizumab or Bevacizumab biosimilar; Drug: Fluoropyrimidine (FP)
Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ FluoropyrimidineExperimentalPD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Receives: Drug: Alcestobart; Drug: Tislelizumab; Drug: Bevacizumab or Bevacizumab biosimilar; Drug: Fluoropyrimidine (FP)
Phase 2: Arm E: PD-L1-negative: Bevacizumab + FluoropyrimidineActive comparatorPD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
Receives: Drug: Bevacizumab or Bevacizumab biosimilar; Drug: Fluoropyrimidine (FP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)

    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose-

    • resulted in death,
    • was life threatening,
    • required hospitalization or prolongation of existing hospitalization,
    • resulted in disability/incapacity,
    • was a congenital anomaly/birth defect.

    Measured: From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.

  2. Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C

    PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occured first.

    Measured: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

Secondary outcomes (6)

  1. Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C

    ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1.

    • CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
    • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

  2. Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Positive Arms A and C

    DOR is defined as the time from the first determination of an objective confirmed response after randomization until the first documentation of disease progression or death, whichever comes first.

    Measured: From first documented response until disease progression or death (maximum follow-up time for DOR was 4.2 months)

  3. Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Negative Arms D and E

    PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first.

    Measured: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months)

  4. Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Negative Arms D and E

    ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1.

    • CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
    • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months))

  5. Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Negative Arms D and E

    DOR, defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first.

    Measured: From first documented response until disease progression or death (maximum follow-up time for DOR was 2.8 months)

  6. Phase 2: Number of Participants With Treatment-emergent AEs and SAEs

    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose-

    • resulted in death,
    • was life threatening,
    • required hospitalization or prolongation of existing hospitalization,
    • resulted in disability/incapacity,
    • was a congenital anomaly/birth defect.

    Measured: From first dose of study drug up to 30 days after last dose; maximum time on treatment in Phase 2 was 10.9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2022
  2. Study start29 Jan 2023
  3. Primary completion23 May 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05609370
Sponsor's protocol ID
BGB-A317-LBL-007-201
Other IDs
CTR20223077
Status last verified
Jul 2026
First submitted
20 Oct 2022
Last updated
23 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Alcestobart, Tislelizumab and Bevacizumab or Bevacizumab biosimilar in people with Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer, run by BeiGene at 64 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, China, Australia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) (time frame: From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05609370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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