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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
1/01/2025

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
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
Secondary ID [1] 0 0
CTR20223077
Secondary ID [2] 0 0
BGB-A317-LBL-007-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LBL-007
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Bevacizumab or Bevacizumab biosimilar
Treatment: Drugs - Capecitabine
Treatment: Drugs - 5-Fluorouracil

Experimental: Phase 1b: Cohort -1: LBL-007 + Tislelizumab + Bevacizumab + Capecitabine - LBL-007 (low dose) + tislelizumab (low dose once every 3 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks) + capecitabine

Experimental: Phase 1b: Cohort 1a: LBL-007 + Tislelizumab + Bevacizumab + Capecitabine - LBL-007 (medium dose) + tislelizumab (low dose once every 3 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks) + capecitabine

Experimental: Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5-Fluorouracil (5-FU) - LBL-007 (medium dose) + tislelizumab (high dose once every 4 weeks) + bevacizumab (5 mg/kg once every 2 weeks) + 5-FU

Experimental: Phase 1b: Cohort 2: LBL-007 + Tislelizumab + Bevacizumab + Fluoropyrimidine - LBL-007 (high dose) + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)

Experimental: Phase 2: Arm A and Arm D: LBL-007 + Tislelizumab + Bevacizumab + Fluoropyrimidine - LBL-007 (high dose) + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)

Experimental: Phase 2: Arm B: LBL-007 + Bevacizumab + Fluoropyrimidine - LBL-007 (high dose) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)

Active comparator: Phase 2: Arm C and Arm E: Bevacizumab + Fluoropyrimidine - Bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine)


Treatment: Drugs: LBL-007
Administered intravenously.

Treatment: Drugs: Tislelizumab
Administered intravenously.

Treatment: Drugs: Bevacizumab or Bevacizumab biosimilar
Administered intravenously

Treatment: Drugs: Capecitabine
Administered in accordance with relevant local guidelines and/or prescribing information

Treatment: Drugs: 5-Fluorouracil
Administered in accordance with relevant local guidelines and/or prescribing information
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1b: Number of participants with Adverse Events (AEs) and Serious AEs (SAEs)
Timepoint [1] 0 0
From the first dose of study drug(s) to 30 days after last dose, initiation of new anticancer therapy, death, withdrawal of consent, or loss to follow-up, whichever occurs first (up to approximately 12 months)
Primary outcome [2] 0 0
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C
Timepoint [2] 0 0
Approximately 12 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Approximately 24 months
Secondary outcome [2] 0 0
Phase 2: Progression Free Survival 2 (PFS2) as Assessed by The Investigator in PD-L1 Positive Arms A and C and PD-L1 Negative Arms D and E
Timepoint [2] 0 0
Approximately 24 months
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Approximately 12 months
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Approximately 12 months
Secondary outcome [5] 0 0
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Negative Arms D and E
Timepoint [5] 0 0
Approximately 12 months
Secondary outcome [6] 0 0
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
Timepoint [6] 0 0
Approximately 12 months
Secondary outcome [7] 0 0
Phase 2: Overall Survival (OS) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
Timepoint [7] 0 0
Approximately 24 months
Secondary outcome [8] 0 0
Phase 2: PFS2 as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
Timepoint [8] 0 0
Approximately 24 months
Secondary outcome [9] 0 0
Phase 2: Objective Response rate (ORR) as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
Timepoint [9] 0 0
Approximately 12 months
Secondary outcome [10] 0 0
Phase 2: DOR as Assessed by The Investigator in Arms A + D and Arms C + E Regardless of PD-L1 Expression
Timepoint [10] 0 0
Approximately 12 months
Secondary outcome [11] 0 0
Phase 2: Number of participants with AEs and SAEs
Timepoint [11] 0 0
From the first dose of study drug(s) to 30 days after the last dose, initiation of new anticancer therapy, death, withdrawal of consent, or loss to follow-up, whichever occurs first (up to approximately 12 months)
Secondary outcome [12] 0 0
Phase 1b: Maximum Concentration (Cmax) of LBL-007
Timepoint [12] 0 0
Cycle 1 and Cycle 5, predose and up to 336 hours postdose
Secondary outcome [13] 0 0
Phase 1b: Time to achieve Maximum Concentration (Tmax) of LBL-007
Timepoint [13] 0 0
Cycle 1 and Cycle 5, predose and up to 336 hours postdose
Secondary outcome [14] 0 0
Phase 1b: Area Under the Concentration Curve from Day 0 to Day 21(AUC 0-21)
Timepoint [14] 0 0
Cycle 1 and Cycle 5, predose and up to 336 hours postdose
Secondary outcome [15] 0 0
Phase 1b: Mean Half Life (t1/2) of LBL-007
Timepoint [15] 0 0
Cycle 1 and Cycle 5, predose and up to 336 hours postdose
Secondary outcome [16] 0 0
Phase 1b: Clearance (CL) of LBL-007
Timepoint [16] 0 0
Cycle 1 and Cycle 5, predose and up to 336 hours postdose
Secondary outcome [17] 0 0
Phase 1b: Apparent Volume of Distribution (Vz) of LBL-007
Timepoint [17] 0 0
Cycle 1 and Cycle 5, predose and up to 336 hours postdose
Secondary outcome [18] 0 0
Phase 2: Cmax of LBL-007, Tislelizumab, and Bevacizumab
Timepoint [18] 0 0
Cycle 1 and Cycle 5 end of infusion (for capecitabine) or Cycle 1 and Cycle 8 end of infusion (for 5-FU) (each cycle is 21 days)
Secondary outcome [19] 0 0
Phase 2: Minimum Concentration (Cmin) of LBL-007, Tislelizumab, and Bevacizumab
Timepoint [19] 0 0
Predose at Cycle 5 (for capecitabine) or Cycle 8 (for 5-FU) (each cycle is 21 days)
Secondary outcome [20] 0 0
Number of Participants with anti-drug antibodies (ADAs) to Tislelizumab, and Bevacizumab in Arm A, Arm B and Arm D
Timepoint [20] 0 0
Up to approximately 12 months

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. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/04/2026
Actual
Sample size
Target
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Orange Health Service (Central West Cancer Care Centre) - Orange
Recruitment hospital [3] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [6] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [7] 0 0
Flinders Centre For Innovation in Cancer (Fcic) - Bedford Park
Recruitment hospital [8] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [9] 0 0
Monash Health - Clayton
Recruitment hospital [10] 0 0
Austin Health - Heidelberg
Recruitment hospital [11] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
St John of God, Murdoch - Murdoch
Recruitment hospital [13] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2800 - Orange
Recruitment postcode(s) [3] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
4217 - Benowa
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6150 - Murdoch
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
China
State/province [18] 0 0
Anhui
Country [19] 0 0
China
State/province [19] 0 0
Beijing
Country [20] 0 0
China
State/province [20] 0 0
Fujian
Country [21] 0 0
China
State/province [21] 0 0
Gansu
Country [22] 0 0
China
State/province [22] 0 0
Guangdong
Country [23] 0 0
China
State/province [23] 0 0
Henan
Country [24] 0 0
China
State/province [24] 0 0
Hubei
Country [25] 0 0
China
State/province [25] 0 0
Hunan
Country [26] 0 0
China
State/province [26] 0 0
Jiangsu
Country [27] 0 0
China
State/province [27] 0 0
Jilin
Country [28] 0 0
China
State/province [28] 0 0
Ningxia
Country [29] 0 0
China
State/province [29] 0 0
Shandong
Country [30] 0 0
China
State/province [30] 0 0
Shanghai
Country [31] 0 0
China
State/province [31] 0 0
Shanxi
Country [32] 0 0
China
State/province [32] 0 0
Tianjin
Country [33] 0 0
China
State/province [33] 0 0
Xinjiang
Country [34] 0 0
China
State/province [34] 0 0
Zhejiang
Country [35] 0 0
Puerto Rico
State/province [35] 0 0
Rio Piedras

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
1-877-828-5568
Fax 0 0
Email 0 0
[email protected]
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