Trial 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
NCT ID:
NCT05609370
Condition:
Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Tislelizumab
Capecitabine
Fluorouracil
Conditions: Keywords:
Colorectal Cancer
Microsatellite Stable
Mismatch Repair Proficient
Maintenance Therapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LBL-007
Description:
Low dose intravenously (IV) once every 3 weeks.
Arm group label:
Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine
Intervention type:
Drug
Intervention name:
LBL-007
Description:
Medium dose IV once every 3 weeks
Arm group label:
Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm group label:
Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)
Intervention type:
Drug
Intervention name:
LBL-007
Description:
High dose IV once every 2 or 3 weeks
Arm group label:
Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Low dose IV once every 3 weeks
Arm group label:
Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm group label:
Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm group label:
Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Other name:
BGB-A-317
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
High dose IV once every 4 weeks
Arm group label:
Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)
Arm group label:
Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Other name:
BGB-A-317
Intervention type:
Drug
Intervention name:
Bevacizumab biosimilar
Description:
7.5 mg/kg IV every 3 weeks
Arm group label:
Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm group label:
Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm group label:
Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine
Intervention type:
Drug
Intervention name:
Bevacizumab biosimilar
Description:
5 mg/kg IV once every 2 weeks
Arm group label:
Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)
Arm group label:
Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
850 milligrams per square meter (mg/m^2) twice daily orally for 2 weeks, followed by a
one-week treatment break every 3 weeks
Arm group label:
Phase 1b: Cohort 1a: LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm group label:
Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 1b: Cohort-1: LBL-007 + tislelizumab + bevacizumab + capecitabine
Arm group label:
Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine
Intervention type:
Drug
Intervention name:
5-Fluorouracil
Description:
1600 to 2400 mg/m^2 IV every 2 weeks
Arm group label:
Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5- Flurouracil (5-FU)
Arm group label:
Phase 1b: Cohort 2: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm A and Arm D: LBL-007 + tislelizumab + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm B: LBL-007 + bevacizumab + fluoropyrimidine
Arm group label:
Phase 2: Arm C and Arm E: bevacizumab + fluoropyrimidine
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.
Criteria for eligibility:
Criteria:
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
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner Md Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Facility:
Name:
Toi Clinical Research
Address:
City:
Cerritos
Zip:
90703
Country:
United States
Status:
Recruiting
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Suspended
Facility:
Name:
Ochsner Clinic Foundation
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital
Address:
City:
Mineola
Zip:
11501
Country:
United States
Status:
Recruiting
Facility:
Name:
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Blacktown Cancer and Haematology Centre
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Status:
Recruiting
Facility:
Name:
Riverina Cancer Care Centre
Address:
City:
Wagga Wagga
Zip:
2650
Country:
Australia
Status:
Recruiting
Facility:
Name:
Calvary Mater Newcastle
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Status:
Recruiting
Facility:
Name:
Pindara Private Hospital
Address:
City:
Benowa
Zip:
4217
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
St John of God, Murdoch
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Facility:
Name:
One Clinical Research
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Second Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230601
Country:
China
Status:
Recruiting
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Tsinghua Changgung Hospital
Address:
City:
Beijing
Zip:
102218
Country:
China
Status:
Recruiting
Facility:
Name:
Quanzhou First Affliated Hospital of Fujian Medical University
Address:
City:
Quanzhou
Zip:
362000
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Facility:
Name:
Zhujiang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Shantou University Medical College
Address:
City:
Shantou
Zip:
515041
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Facility:
Name:
Nantong First Peoples Hospital
Address:
City:
Nantong
Zip:
215124
Country:
China
Status:
Recruiting
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Facility:
Name:
Jining No Peoples Hospital West Branch
Address:
City:
Jining
Zip:
272000
Country:
China
Status:
Recruiting
Facility:
Name:
Linyi Peoples Hospital
Address:
City:
Linyi
Zip:
276000
Country:
China
Status:
Recruiting
Facility:
Name:
Renji Hospital Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai East Hospital Branch Hospital
Address:
City:
Shanghai
Zip:
200123
Country:
China
Status:
Recruiting
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Facility:
Name:
Karamay Central Hospital of Xinjiang
Address:
City:
Karamay
Zip:
834009
Country:
China
Status:
Recruiting
Facility:
Name:
The Xinjiang Uygur Autonomous Region Peoples Hospital
Address:
City:
Urumqi
Zip:
830001
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Facility:
Name:
Pan American Oncology Trials, Llc
Address:
City:
Rio Piedras
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Start date:
January 29, 2023
Completion date:
April 2028
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05609370
