Phase
Condition
Neoplasms
Treatment
Tislelizumab
LBL-007
BGB-A425
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
Adequate organ function
Phase 1 Dose Escalation + Phase 2 Safety Lead-In: Participants with histologicallyor cytologically confirmed advanced, metastatic, unresectable solid tumors who havepreviously received standard systemic therapy or for which treatment is notavailable, not tolerated or refused.
Phase 2 Dose-Expansion: Participants with one of the following histologically orcytologically confirmed solid tumors:
For HNSCC participants in cohort 1,4 and 6 (PD-L1 positive):
Recurrent/metastatic head and neck squamous cell cancer of the oral cavity, oropharynx, hypopharynx, and/or larynx whose tumor is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy • For NSCLC participants in Cohort 2, 5 and 7 (PD-L1 positive): Locally recurrent Stage IIIB, stage IIIC or Stage IV squamous or non-squamous non-small cell lung cancer
• For RCC participants in Cohort 3: Locally advanced unresectable or metastatic and histologically confirmed renal cell carcinoma with a clear cell histology
Exclusion
Key Exclusion Criteria:
NSCLC patients with known EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion
Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
Interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases
Uncontrolled diabetes or significant cardiac issues
Infections requiring systemic antibacterial, antifungal, or antiviral therapy
History of severe hypersensitivity reactions to other monoclonal antibodies
History of HIV infection or untreated chronic hepatitis B or chronic hepatitis Bvirus carriers
Major surgical procedure within 28 days before study drug administration
Chemotherapy, radiotherapy, immunotherapy or any investigational therapies within 28days (PH 2 Safety Lead-In) or 14 days (PH 2 Dose Expansion) or 5 half-lives of (whichever is shorter) of first administration of study drug(s).
With infections (including tuberculosis infection, etc) requiring systemicantibacterial, antifungal, or antiviral therapy ≤ 14 days prior to the first dose ofstudy drug(s), or a requirement for chronic prophylactic treatment with antibiotics.
Concurrent participation in another therapeutic clinical trial
Received prior therapies targeting TIM-3and/or LAG3
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Sydney Southwest Private Hospital
Liverpool, New South Wales 2170
AustraliaSite Not Available
Sydney Southwest Private Hospital
Sydney, New South Wales 2170
AustraliaSite Not Available
Sunshine Coast Hospital and Health Service
Birtinya, Queensland 4575
AustraliaSite Not Available
Sunshine Coast University Hospital
Birtinya, Queensland 4575
AustraliaActive - Recruiting
Gold Coast University Hospital
Gold Coast, Queensland 4215
AustraliaSite Not Available
Cancer Care Service Hervey Bay Hospital
Hervey Bay, Queensland
AustraliaSite Not Available
Gold Coast University Hospital
Southport, Queensland 4215
AustraliaSite Not Available
Calvary North Adelaide Hospital
Adelaide, South Australia 5006
AustraliaSite Not Available
Lyell McEwin Hospital
Adelaide, South Australia 5112
AustraliaActive - Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
AustraliaSite Not Available
Calvary North Adelaide Hospital
North Adelaide, South Australia 5006
AustraliaSite Not Available
Box Hill Hospital
Box Hill, Victoria 3128
AustraliaSite Not Available
Cabrini Hospital Malvern
Malvern, Victoria 3144
AustraliaActive - Recruiting
Cabrini Research and Education Institute
Malvern, Victoria 3144
AustraliaSite Not Available
Box Hill Hospital
Melbourne, Victoria 3128
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3128
AustraliaSite Not Available
Peter Maccallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
Western Health- Sunshine Hospital
Melbourne, Victoria 3021
AustraliaActive - Recruiting
Western Health Sunshine Hospital
St Albans, Victoria 3021
AustraliaSite Not Available
Hollywood Private Hospital
Nedlands, Western Australia 6009
AustraliaSite Not Available
Linear Clinical Research
Nedlands, Western Australia 6009
AustraliaSite Not Available
Hollywood Private Hospital
Perth, Western Australia 6009
AustraliaActive - Recruiting
Linear Clinical Research
Perth, Western Australia 6009
AustraliaSite Not Available
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076
FranceSite Not Available
Centre de Lutte Contre Le Cancer Francois Baclesse
Caen, 14000
FranceSite Not Available
Institut Curie Paris
Paris, 75005
FranceSite Not Available
Institut Curie
SaintCloud, 92210
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna, 40138
ItalySite Not Available
Fondazione Irccs Istituto Nazionale Dei Tumori
Milano, 20133
ItalySite Not Available
Istituto Di Candiolo Irccs
Torino, 10060
ItalySite Not Available
Dong A University Hospital
Busan, Busan Gwang'yeogsi 49201
Korea, Republic ofSite Not Available
Chungbuk National University Hospital
Cheongju, Chungcheongbuk-do 28644
Korea, Republic ofSite Not Available
Chungbuk National University Hospital
Cheongju si, Chungcheongbukdo 28644
Korea, Republic ofSite Not Available
Chungbuk National University Hospital
Cheongjusi, Chungcheongbukdo 28644
Korea, Republic ofSite Not Available
National Cancer Centre
Goyang, Gyeonggi-do 10408
Korea, Republic ofSite Not Available
CHA Bundang Medical Center, CHA University
Seongnam, Gyeonggi-do 13496
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do 13620
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do 16499
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St. Vincent's Hospital
Suwon, Gyeonggi-do 16247
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Suwonsi, Gyeonggi-do 16499
Korea, Republic ofSite Not Available
The Catholic University of Korea, St Vincents Hospital
Suwonsi, Gyeonggi-do 16247
Korea, Republic ofSite Not Available
National Cancer Center
Goyang si, Gyeonggido 10408
Korea, Republic ofSite Not Available
National Cancer Center
Goyangsi, Gyeonggido 10408
Korea, Republic ofSite Not Available
Cha Bundang Medical Center, Cha University
Gyeonggi-do, Gyeonggido 13496
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido 13620
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnamsi, Gyeonggido 13620
Korea, Republic ofSite Not Available
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi 21565
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St Marys Hospital
Seoul, Seoul Teugbyeolsi 06591
Korea, Republic ofSite Not Available
Ulsan University Hospital
Donggu, Ulsan Gwang'yeogsi 44033
Korea, Republic ofSite Not Available
Dong-A University Hospital
Busan, 49201
Korea, Republic ofActive - Recruiting
National Cancer Centre
Gyeonggi-do, 137-701
Korea, Republic ofSite Not Available
Cha Bundang Medical Center, Cha University
Gyeonggido, 13496
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University
Seoul, 03722
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofActive - Recruiting
Ulsan University Hospital
Ulsan, 44033
Korea, Republic ofSite Not Available
Centrum Onkologiiim Prof F Lukaszczyka Wbydgoszczy
Bydgoszcz, 85-796
PolandSite Not Available
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
Warszawa, 02-034
PolandSite Not Available
Ico Hug Trias I Pujol
Barcelona, 08916
SpainSite Not Available
Institut Catala Dandoncologia
Barcelona, 08908
SpainActive - Recruiting
Institut Catala Doncologia
Barcelona, 08908
SpainSite Not Available
Vall D Hebron Institute of Oncology Vhio
Barcelona, 08035
SpainActive - Recruiting
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Universitario Hm Madrid Sanchinarro
Madrid, 28050
SpainSite Not Available
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainSite Not Available
Banner MD Anderson Cancer Center
Phoenix, Arizona 85234
United StatesSite Not Available
Chao Family Comprehensive Cancer Center
Orange, California 92868
United StatesSite Not Available
UCI Chao Family Comprehensive Cancer Center
Orange, California 92868
United StatesSite Not Available
University of Colorado Cancer Center
Aurora, Colorado 80014
United StatesSite Not Available
University of Colorado Cancer Centre
Aurora, Colorado 80045
United StatesSite Not Available
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesSite Not Available
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesSite Not Available
University of Kentucky Hospital
Lexington, Kentucky 40536
United StatesActive - Recruiting
University of Kentucky Markey Cancer Center
Lexington, Kentucky 40536
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Weill Cornell Medical College
New York, New York 10065
United StatesActive - Recruiting
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York 10021
United StatesSite Not Available
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina 27514
United StatesSite Not Available
University of North Carolina and Chapel Hill
Chapel Hill, North Carolina 27514
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United StatesActive - Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Fox Chase Cancer Centre
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Oncology Consultants, P.A.
Houston, Texas 77024-2545
United StatesActive - Recruiting
The University of Texas Md Anderson Cancer Center
Houston, Texas 77030-4009
United StatesSite Not Available
The University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Xcanceroncology Consultants
Houston, Texas 77030
United StatesActive - Recruiting
UT Health San Antonio Mays Cancer Center
San Antonio, Texas 78229
United StatesActive - Recruiting
Ut Health San Antonio Mays Cancer Center
San Antonio, Texas 78229
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
Schar Cancer Institute
Fairfax, Virginia 22031
United StatesSite Not Available
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