BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
NCT ID: NCT06120283
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
300 participants
INTERVENTIONAL
2023-12-01
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation and Safety Expansion
Phase 1a: Sequential cohorts of increasing dose levels of BGB-43395 will be evaluated as monotherapy and in combination with either fulvestrant, letrozole, or elacestrant to assess for safety and tolerability.
BGB-43395
Planned doses administered orally.
Fulvestrant
Standard dose administered via intramuscular injection.
Letrozole
Standard dose administered orally as a tablet.
Elacestrant
Standard dose administered orally as a tablet.
Dose Expansion
Phase 1b: The recommended dose for expansion (RFDE) for BGB-43395 (in combination with fulvestrant or letrozole) from Phase 1a will be evaluated in HR+ breast cancer and selected tumor-specific cohorts.
BGB-43395
Planned doses administered orally.
Fulvestrant
Standard dose administered via intramuscular injection.
Letrozole
Standard dose administered orally as a tablet.
Interventions
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BGB-43395
Planned doses administered orally.
Fulvestrant
Standard dose administered via intramuscular injection.
Letrozole
Standard dose administered orally as a tablet.
Elacestrant
Standard dose administered orally as a tablet.
Eligibility Criteria
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Inclusion Criteria
* Phase 1a: Received prior therapy for their condition (if available) and should be refractory to, or intolerant of standard-of-care therapies. In regions where approved and available, participants with HR+ breast cancer must have received at least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced/metastatic disease including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting.
* Phase 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additional tumor types.
* Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received at least one line of therapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease.
* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
* Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
* Adequate organ function without symptomatic visceral disease.
Exclusion Criteria
* Known leptomeningeal disease or uncontrolled, untreated brain metastases.
* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
* Uncontrolled diabetes.
* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.
* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at screening.
* Participants with active hepatitis C infection.
* Prior allogeneic stem cell transplantation, or organ transplantation.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Sarah Cannon Research Institute (Scri) At Health One
Denver, Colorado, United States
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke Cancer Center
Durham, North Carolina, United States
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Scri Oncology Partners
Nashville, Tennessee, United States
Next Oncology
Austin, Texas, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Next Dallas
Irving, Texas, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Southern Highlands Private Hospital
Bowral, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Macquarie University
North Ryde, New South Wales, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Genesiscare St Andrews
Adelaide, South Australia, Australia
Austin Health
Heidelberg, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, , Brazil
Hospital Sirio Libanes Brasilia
Brasília, , Brazil
Centro de Pesquisas Oncologicas Cepon
Florianópolis, , Brazil
Liga Norte Riograndene Contra O Cancer
Natal, , Brazil
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
Petrópolis, , Brazil
Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia
Porto Algre, , Brazil
Instituto Nacional de Cancer
Rio de Janeiro, , Brazil
Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael
Salvador, , Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, , Brazil
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
São Paulo, , Brazil
Hospital Israelita Albert Einstein
São Paulo, , Brazil
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, China
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
Centre Oscar Lambret
Lille, , France
Institut Paoli Calmettes
Marseille, , France
Institut Curie
Paris, , France
Centre Eugene Marquis
Rennes, , France
Institut de Cancerologie de Louest
Saint-Herblain, , France
Institut Gustave Roussy
Villejuif, , France
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Shizuoka Cancer Center
Suntogun, Shizuoka, Japan
Pulau Pinang Hospital
George Town, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
National Cancer Institute (Institut Kanser Negara)
Putrajaya, , Malaysia
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, , Moldova
Harbour Cancer and Wellness
Auckland, , New Zealand
Nzcr Christchurch
Christchurch, , New Zealand
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do, South Korea
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Korea University Anam Hospital
SeongbukGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Srinagarind Hospital (Khon Kaen University)
Muang, , Thailand
Countries
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Central Contacts
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Other Identifiers
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2023-506888-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CTR20243370
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-43395-101
Identifier Type: -
Identifier Source: org_study_id