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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05609370
Registration number
NCT05609370
Ethics application status
Date submitted
20/10/2022
Date registered
8/11/2022
Date last updated
20/08/2024
Titles & IDs
Public title
A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer
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Scientific 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
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Secondary ID [1]
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CTR20223077
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Secondary ID [2]
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BGB-A317-LBL-007-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LBL-007
Treatment: Drugs - LBL-007
Treatment: Drugs - LBL-007
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Bevacizumab biosimilar
Treatment: Drugs - Bevacizumab biosimilar
Treatment: Drugs - Capecitabine
Treatment: Drugs - 5-Fluorouracil
Experimental: Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine - LBL-007 + tislelizumab + bevacizumab + capecitabine
Experimental: Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine - LBL-007 + tislelizumab + bevacizumab + capecitabine
Experimental: Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine - LBL-007 + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks)+ fluoropyrimidine (5-FU or capecitabine)
Experimental: Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine - LBL-007 + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Experimental: Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine - LBL-007 + bevacizumab (7.5 mg/kgonce every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Other: Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine - bevacizumab (7.5 mg/kg once every 2 weeks or 5 mg/kg once every 3 weeks) + fluoropyrimidine (5-FU or capecitabine)
Experimental: Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU) - LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil
Treatment: Drugs: LBL-007
Low dose intravenously (IV) once every 3 weeks.
Treatment: Drugs: LBL-007
Medium dose IV once every 3 weeks
Treatment: Drugs: LBL-007
High dose IV once every 2 or 3 weeks
Treatment: Drugs: Tislelizumab
Low dose IV once every 3 weeks
Treatment: Drugs: Tislelizumab
High dose IV once every 4 weeks
Treatment: Drugs: Bevacizumab biosimilar
7.5 mg/kg IV every 3 weeks
Treatment: Drugs: Bevacizumab biosimilar
5 mg/kg IV once every 2 weeks
Treatment: Drugs: Capecitabine
850 milligrams per square meter (mg/m\^2) twice daily orally for 2 weeks, followed by a one-week treatment break every 3 weeks
Treatment: Drugs: 5-Fluorouracil
1600 to 2400 mg/m\^2 IV every 2 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1b: Number of participants with Adverse events (AE) and Serious AEs (SAE)
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Assessment method [1]
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AEs and SAE are characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 \[NCI-CTCAE v5.0\])
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Timepoint [1]
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First Cycle of treatment (21 days)
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Primary outcome [2]
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Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C
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Assessment method [2]
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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
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Timepoint [2]
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Approximately 44 months
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Secondary outcome [1]
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Phase 2: Overall Survival (OS) as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative Arms D and E
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Assessment method [1]
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OS is defined as the time from the date of randomization until the date of death from any cause.
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Timepoint [1]
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Approximately 44 months
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Secondary outcome [2]
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Phase 2: PFS 2 as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative Arms D and E
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Assessment method [2]
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PFS2 is defined as the time from the date of randomization to the date of documentation of disease progression in second-line treatment, or death, whichever occurs first
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Timepoint [2]
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Approximately 44 months
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Secondary outcome [3]
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Phase 2: Objective Response rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative Arms D and E
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Assessment method [3]
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ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization
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Timepoint [3]
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Approximately 44 months
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Secondary outcome [4]
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Phase 2: Duration of response (DOR) as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative arms D and E
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Assessment method [4]
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DOR is defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first
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Timepoint [4]
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Approximately 44 months
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Secondary outcome [5]
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Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Negative Arms D and E
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Assessment method [5]
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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
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Timepoint [5]
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Approximately 44 months
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Secondary outcome [6]
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Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
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Assessment method [6]
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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
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Timepoint [6]
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Approximately 44 months
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Secondary outcome [7]
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Phase 2: Overall Survival (OS) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
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Assessment method [7]
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OS is defined as the time from the date of randomization until the date of death from any cause.
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Timepoint [7]
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Approximately 44 months
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Secondary outcome [8]
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Phase 2: PFS 2 as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
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Assessment method [8]
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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
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Timepoint [8]
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Approximately 44 months
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Secondary outcome [9]
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Phase 2: Objective Response rate (ORR) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
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Assessment method [9]
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ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization
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Timepoint [9]
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Approximately 44 months
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Secondary outcome [10]
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Phase 2: DOR as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
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Assessment method [10]
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DOR is defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first
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Timepoint [10]
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Approximately 44 months
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Secondary outcome [11]
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Phase 2 : Number of participants with Adverse events (AE) and Serious AEs (SAE)
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Assessment method [11]
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AEs and SAE are characterized by type, frequency, severity as graded by NCI-CTCAE v5.0
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Timepoint [11]
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Up to last dose + 30 days (Approximately 44 months)
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Secondary outcome [12]
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Phase 1b: Maximum Concentration (Cmax) of LBL-007
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Assessment method [12]
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Timepoint [12]
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Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
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Secondary outcome [13]
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Phase 1b: Time to achieve Maximum Concentration (Tmax) of LBL-007
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Assessment method [13]
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Timepoint [13]
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Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
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Secondary outcome [14]
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Phase 1b: Area Under the Concentration Curve from Day 0 to Day 21(AUC 0-21)
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Assessment method [14]
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Timepoint [14]
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Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
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Secondary outcome [15]
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Phase 1b: Mean Half Life (t1/2) of LBL-007
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Assessment method [15]
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Timepoint [15]
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Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
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Secondary outcome [16]
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Phase 1b: Clearance (CL) of LBL-007
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Assessment method [16]
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Timepoint [16]
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Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
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Secondary outcome [17]
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Phase 1b: Apparent Volume of Distribution (Vz) of LBL-007
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Assessment method [17]
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Timepoint [17]
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Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
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Secondary outcome [18]
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Phase 2: Cmax of LBL-007, Tislelizumab, and Bevacizumab
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Assessment method [18]
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Timepoint [18]
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Up to approximately 27 months (predose at cycle 1,2,5,9,17, safety follow-up (each cycle 21 days))
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Secondary outcome [19]
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Phase 2: Cmin of LBL-007, Tislelizumab, and Bevacizumab
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Assessment method [19]
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Timepoint [19]
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Cycle 1 Day 1 (C1D1) Predose, End of Infusion (EOI) 6 hours (h), C1D2, C1D4, C1D8, and C1D15, C2 to C25 D1 Predose and EOI (each cycle 21 days)
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Secondary outcome [20]
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Number of Participants with anti-drug antibodies (ADAs) to Tislelizumab, and Bevacizumab in Arm A, Arm B and Arm D
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Assessment method [20]
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Timepoint [20]
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Up to approximately 27 months (predose at cycle 1,2,5,9,17, safety follow-up, and EOI at cycle 1 and 5 (each cycle 21 days))
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Eligibility
Key inclusion criteria
* Participant must have measurable disease as defined per RECIST 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participants whose disease has become resectable at the investigator's discretion during or after induction treatment are not eligible
* Induction treatment initiated less than 6 months from completion of any prior neoadjuvant or adjuvant chemotherapy or radiotherapy which 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2028
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Actual
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Sample size
Target
226
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Blacktown Cancer and Haematology Centre - Blacktown
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Recruitment hospital [2]
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Orange Health Service (Central West Cancer Care Centre) - Orange
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Recruitment hospital [3]
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Riverina Cancer Care Centre - Wagga Wagga
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Recruitment hospital [4]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [5]
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Pindara Private Hospital - Benowa
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Recruitment hospital [6]
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Icon Cancer Care South Brisbane - South Brisbane
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Recruitment hospital [7]
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Flinders Centre For Innovation in Cancer (Fcic) - Bedford Park
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Recruitment hospital [8]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [9]
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Monash Health - Clayton
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Recruitment hospital [10]
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Austin Health - Heidelberg
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Recruitment hospital [11]
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The Alfred Hospital - Melbourne
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Recruitment hospital [12]
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St John of God, Murdoch - Murdoch
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Recruitment hospital [13]
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One Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2800 - Orange
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Recruitment postcode(s) [3]
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2650 - Wagga Wagga
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Recruitment postcode(s) [4]
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2298 - Waratah
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Recruitment postcode(s) [5]
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4217 - Benowa
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Recruitment postcode(s) [6]
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4101 - South Brisbane
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Recruitment postcode(s) [7]
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5042 - Bedford Park
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Recruitment postcode(s) [8]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [9]
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3168 - Clayton
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Recruitment postcode(s) [10]
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3084 - Heidelberg
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Recruitment postcode(s) [11]
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3004 - Melbourne
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Recruitment postcode(s) [12]
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6150 - Murdoch
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Recruitment postcode(s) [13]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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Alaska
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Missouri
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Montana
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Nevada
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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China
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Anhui
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China
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Beijing
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China
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Fujian
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China
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Gansu
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China
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Guangdong
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China
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Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jilin
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China
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Ningxia
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China
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Shandong
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China
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Shanghai
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China
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Shanxi
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China
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Tianjin
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China
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Xinjiang
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China
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Zhejiang
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Puerto Rico
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Rio Piedras
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 1b/2 study to investigate the efficacy and safety of LBL-007 plus Tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine to participants with colorectal cancer.
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Trial website
https://clinicaltrials.gov/study/NCT05609370
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BeiGene
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Address
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Country
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Phone
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1-877-828-5568
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05609370
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