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A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Capecitabine Versus Bevacizumab Plus Capecitabine in Participants With Unresectable or Metastatic Colorectal Cancer

Program Status

Active, not recruiting

Phase

Phase 1 Phase 2

Prior Immunotherapy Allowed

CRC-directed Trial

Yes

Drugs

Bevacizumab, capecitabine, LBL-007, Tislelizumab

Tags

MSS/ MMRp

Comments

For MSS CRC patients who are about to start first line of treatment in the metastatic setting (no prior chemo for metastatic cancer allowed). Patients with BRAF V600E mutated cancer are excluded from participation.
Standard of care (bevacizumab + fluoropyrimidine (5-FU or capecitabine)) vs different combinations/ different doses of two experimental agents, immunotherapies:
tislelizumab: anti PD-1, checkpoint inhbitor.
LBL-007: anti LAG-3 antibody (immunotherapy targeting human Lymphocyte-activation gene3 (LAG-3).

Helpful Links

Liberty-201: maintenance capecitabine and bevacizumab with or without anti-lymphocyte activation gene 3 (LAG3) antibody LBL-007 plus anti-programmed cell death protein 1 (PD-1) antibody tislelizumab (TIS) for patients (pts) with metastatic or unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer (CRC)

Location	Location Status
United States
Alaska Oncology and Hematology, Llc Anchorage, Alaska 99508	Active, not recruiting
Banner Md Anderson Cancer Center Gilbert, Arizona 85234	Active, not recruiting
Toi Clinical Research Cerritos, California 90703	Active, not recruiting
Usc Norris Comprehensive Cancer Center (Nccc) Los Angeles, California 90033	Active, not recruiting
Valkyrie Clinical Trials Los Angeles, California 90067	Active, not recruiting
UCLA Los Angeles, California 90095	Active, not recruiting
Hoag Memorial Presbyterian Newport, California 92663	Active, not recruiting
Kaiser Permanente Northern California Vallejo, California 94510	Active, not recruiting
Baptist Md Anderson Cancer Center Jacksonville, Florida 32207	Active, not recruiting
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana 46804	Active, not recruiting
Baptist Health Lexington Lexington, Kentucky 40503	Active, not recruiting
University of Kentucky Markey Cancer Center Lexington, Kentucky 40536	Active, not recruiting
Norton Cancer Institute Louisville, Kentucky 40217	Active, not recruiting
Pontchartrain Cancer Center Covington, Louisiana 70433	Active, not recruiting
Ochsner Clinic Foundation New Orleans, Louisiana 70121	Active, not recruiting
Washington University School of Medicine Saint Louis, Missouri 63110	Active, not recruiting
St Vincent Frontier Cancer Center Billings, Montana 59102	Active, not recruiting
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada 89169	Active, not recruiting
Cancer Care Specialists Reno, Nevada 89511	Active, not recruiting
University of New Mexico Cancer Center Albuquerque, New Mexico 87102	Active, not recruiting
Perlmutter Cancer Center At Winthrop Oncology Hematology Associatesnyu Winthrop Hospital Mineola, New York 11501	Active, not recruiting
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health New York, New York 10016	Active, not recruiting
Columbia University Medical Center New York, New York 10032	Active, not recruiting
Duke Cancer Center Durham, North Carolina 27710	Active, not recruiting
University of Tennessee Medical Center Knoxville, Tennessee 37920	Active, not recruiting
Ut Southwestern Medical Center Dallas, Texas 75390	Active, not recruiting
Ut Health San Antonio Mays Cancer Center San Antonio, Texas 78229	Active, not recruiting
Virginia Cancer Specialists Fairfax, Virginia 22031	Active, not recruiting
Cancer Care Northwest Spokane Valley, Washington 99216	Active, not recruiting
Multicare Health System Institute For Research and Innovation Tacoma, Washington 98405	Active, not recruiting
Australia
Blacktown Cancer and Haematology Centre Blacktown, New South Wales 2148	Active, not recruiting
Orange Health Service (Central West Cancer Care Centre) Orange, New South Wales 2800	Active, not recruiting
Riverina Cancer Care Centre Wagga Wagga, New South Wales 2650	Active, not recruiting
Calvary Mater Newcastle Waratah, New South Wales 2298	Active, not recruiting
Pindara Private Hospital Benowa, Queensland 4217	Active, not recruiting
Icon Cancer Centre South Brisbane South Brisbane, Queensland 4101	Active, not recruiting
Flinders Centre For Innovation in Cancer (Fcic) Bedford Park, South Australia 5042	Active, not recruiting
Lyell McEwin Hospital Elizabeth Vale, South Australia 5112	Active, not recruiting
Monash Health Clayton, Victoria 3168	Active, not recruiting
Austin Health Heidelberg, Victoria 3084	Active, not recruiting
The Alfred Hospital Melbourne, Victoria 3004	Active, not recruiting
St John of God, Murdoch Murdoch, Western Australia 6150	Active, not recruiting
One Clinical Research Nedlands, Western Australia 6009	Active, not recruiting
China
The Second Hospital of Anhui Medical University Hefei, Anhui 230601	Active, not recruiting
Peking University First Hospital Beijing, Beijing 100034	Active, not recruiting
Beijing Tsinghua Changgung Hospital Beijing, Beijing 102218	Active, not recruiting
Fujian Medical University Union Hospital Fuzhou, Fujian 350001	Active, not recruiting
Quanzhou First Affliated Hospital of Fujian Medical University Quanzhou, Fujian 362000	Active, not recruiting
The First Affiliated Hospital of Xiamen University Xiamen, Fujian 361003	Active, not recruiting
Gansu Provincial Hospital Lanzhou, Gansu 730000	Active, not recruiting
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North) Guangzhou, Guangdong 510000	Active, not recruiting
Zhujiang Hospital of Southern Medical University Guangzhou, Guangdong 510000	Active, not recruiting
The First Affiliated Hospital of Shantou University Medical College Shantou, Guangdong 515041	Active, not recruiting
Nanyang Central Hospital Nanyang, Henan 473000	Active, not recruiting
Henan Cancer Hospital Zhengzhou, Henan 450000	Active, not recruiting
Hubei Cancer Hospital Wuhan, Hubei 430079	Active, not recruiting
Hunan Cancer Hospital Changsha, Hunan 410013	Active, not recruiting
The First Peoples Hospital of Changzhou Changzhou, Jiangsu 213000	Active, not recruiting
Nantong First Peoples Hospital Nantong, Jiangsu 215124	Active, not recruiting
Affiliated Hospital of Jiangnan University South Campus Wuxi, Jiangsu 214122	Active, not recruiting
The First Hospital of Jilin University Changchun, Jilin 130021	Active, not recruiting
General Hospital of Ningxia Medical University Yinchuan, Ningxia 750004	Active, not recruiting
Shandong Cancer Hospital Jinan, Shandong 250117	Active, not recruiting
Jining No.1 Peoples Hospital West Branch Jining, Shandong 272000	Active, not recruiting
Linyi Peoples Hospital Linyi, Shandong 276000	Active, not recruiting
Qingdao Municipal Hospital Qingdao, Shandong 266000	Active, not recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai 200000	Active, not recruiting
Shanghai 10Th Peoples Hospital Shanghai, Shanghai 200072	Active, not recruiting
Shanghai East Hospital Branch Hospital Shanghai, Shanghai 200123	Active, not recruiting
Shanxi Provincial Cancer Hospital Taiyuan, Shanxi 030013	Active, not recruiting
Tianjin Medical University Cancer Institute and Hospital Tianjin, Tianjin 300060	Active, not recruiting
Tianjin Union Medical Center (Nankai University Affiliated Hospital) Tianjin, Tianjin 300121	Active, not recruiting
Karamay Central Hospital of Xinjiang Karamay, Xinjiang 834009	Active, not recruiting
The Xinjiang Uygur Autonomous Region Peoples Hospital Urumqi, Xinjiang 830001	Active, not recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang 310009	Active, not recruiting
Puerto Rico
Pan American Oncology Trials, Llc Rio Piedras 00935	Active, not recruiting

Inclusion 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. 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

Exclusion Criteria

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.

NCT ID

NCT05609370

Date Trial Added

2022-11-08

Updated Date

2025-01-01