Phase
Condition
Breast Cancer
Non-small Cell Lung Cancer
Metastatic Cancer
Treatment
Letrozole
BGB-43395
Fulvestrant
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Phase 1a (Dose Escalation) and 1b (Dose Expansion): Participants with histologicallyor cytologically confirmed advanced, metastatic, or unresectable solid tumorsassociated with dependency on CDK4, including HR+ breast cancer, ovarian cancer,endometrial cancer, non-small cell lung cancer, and others.
Phase 1a: Received prior therapy for their condition (if available) and should berefractory to or intolerant of standard-of-care therapies. In regions where approvedand available, participants with HR+ breast cancer must have received at least 2prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor.
Phase 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additionaltumor types.
Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6inhibitors are approved and available must have received at least one line oftherapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor.Participants can have received up to 2 lines of prior cytotoxic chemotherapy foradvanced disease.
Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Female participants with metastatic HR+/HER2- breast cancer must be postmenopausalor receiving ovarian function suppression treatment.
Adequate organ function without symptomatic visceral disease.
Exclusion
Exclusion Criteria:
Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy ispermitted and required in local regions where it is approved and available).
Known leptomeningeal disease or uncontrolled, untreated brain metastases.
Any malignancy ≤ 3 years before the first dose of study treatment(s) except for thespecific cancer under investigation in this study and any locally recurring cancerthat has been treated with curative intent (eg, resected basal or squamous cell skincancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
Uncontrolled diabetes.
Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28days before the first dose of study drug(s), or symptomatic COVID-19 infection.
History of hepatitis B or active hepatitis C infection.
Prior allogeneic stem cell transplantation, or organ transplantation.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales 2148
AustraliaActive - Recruiting
Southern Highlands Private Hospital
Bowral, New South Wales 2576
AustraliaActive - Recruiting
Concord Repatriation General Hospital
Concord, New South Wales 2139
AustraliaActive - Recruiting
Macquarie University Hospital
Macquarie Park, New South Wales 2109
AustraliaSite Not Available
Macquarie University
North Ryde, New South Wales 2109
AustraliaActive - Recruiting
Townsville University Hospital
Douglas, Queensland 4814
AustraliaActive - Recruiting
Genesiscare St Andrews
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Austin Health
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, 14.784-400
BrazilActive - Recruiting
Hospital Sirio Libanes Brasilia
Brasilia, 70200-730
BrazilActive - Recruiting
Centro de Pesquisas Oncologicas Cepon
Florianopolis, 88034-000
BrazilActive - Recruiting
Liga Norte Riograndene Contra O Cancer
Natal, 59062-000
BrazilActive - Recruiting
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
Petropolis, 95070-560
BrazilActive - Recruiting
Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia
Porto Algre, 90610-000
BrazilActive - Recruiting
Instituto Nacional de Cancer
Rio de Janeiro, 20560-120
BrazilActive - Recruiting
Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael
Salvador, 41253-190
BrazilActive - Recruiting
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
Sao Paulo, 01317-000
BrazilActive - Recruiting
Hospital Israelita Albert Einstein
Sao Paulo, 05652-900
BrazilActive - Recruiting
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
Sao Paulo, 01246-000
BrazilActive - Recruiting
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian 350014
ChinaActive - Recruiting
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong 510245
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150000
ChinaActive - Recruiting
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning 110042
ChinaActive - Recruiting
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai 201321
ChinaActive - Recruiting
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076
FranceSite Not Available
Centre Francois Baclesse
Caen Cedex, 14076
FranceActive - Recruiting
Centre Oscar Lambret
Lille, 59000
FranceActive - Recruiting
Institut Paoli Calmettes
Marseille, 13009
FranceActive - Recruiting
Institut Curie
Paris, 75005
FranceSite Not Available
Centre Eugene Marquis
Rennes, 35043
FranceActive - Recruiting
Institut de Cancerologie de Louest
St Herblain, 44800
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Nagoya University Hospital
Nagoya, Aichi 466-8560
JapanSite Not Available
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
JapanActive - Recruiting
Shizuoka Cancer Center
Suntogun, Shizuoka 411-8777
JapanSite Not Available
Seoul National University Bundang Hospital
Seongnamsi, Gyeonggi-do 13620
Korea, Republic ofActive - Recruiting
Korea University Anam Hospital
Seoul, Gyeonggi-do 02841
Korea, Republic ofActive - Recruiting
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi 21565
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, Seoul Teugbyeolsi 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, Seoul St Marys Hospital
Seoul, Seoul Teugbyeolsi 06591
Korea, Republic ofActive - Recruiting
Pulau Pinang Hospital
Georgetown, 10450
MalaysiaSite Not Available
University Malaya Medical Centre
Kuala Lumpur, 59100
MalaysiaSite Not Available
Sarawak General Hospital
Kuching, 93586
MalaysiaActive - Recruiting
National Cancer Institute (Institut Kanser Negara)
Putrajaya, 62250
MalaysiaSite Not Available
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, 2025
Moldova, Republic ofActive - Recruiting
Harbour Cancer and Wellness
Auckland, 1023
New ZealandActive - Recruiting
Nzcr Christchurch
Christchurch, 8011
New ZealandActive - Recruiting
Siriraj Hospital
Bangkok, 10700
ThailandSite Not Available
Banphaeo General Hospital
Banphaeo, 74120
ThailandSite Not Available
Srinagarind Hospital (Khon Kaen University)
Muang, 40002
ThailandActive - Recruiting
Sarah Cannon Research Institute (Scri) At Health One
Denver, Colorado 80219
United StatesActive - Recruiting
Florida Cancer Specialists and Research Institute
Lake Mary, Florida 32746
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Duke Cancer Center
Durham, North Carolina 27710
United StatesActive - Recruiting
James Cancer Hospital and Solove Research Institute
Columbus, Ohio 43210
United StatesActive - Recruiting
Scri Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
The University of Texas Md Anderson Cancer Center
Houston, Texas 77030-4009
United StatesActive - Recruiting
Next Dallas
Irving, Texas 75039
United StatesActive - Recruiting
Next Oncology
San Antonio, Texas 78229
United StatesActive - Recruiting
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