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BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
NCT06120283 · BeOne Medicines
In plain English
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Official title
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
About this study
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Eligibility criteria
Inclusion Criteria:
* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. 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 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4/6 inhibitor. For combination with letrozole, participants must be CDK4/6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.
* Phase 1b: Participants with HR+/HER2- breast cancer.
* Phase 1b: For combination with fulvestrant, participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced/metastatic disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4/6 inhibitor treatment naïve and have not received any previous systemic treatment 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study design
Enrollment target: 399 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-12-01
Estimated completion: 2028-11
Last updated: 2026-04-15
Interventions
Drug: BGB-43395Drug: FulvestrantDrug: LetrozoleDrug: ElacestrantDrug: Anti-Diarrheal Agent
Primary outcomes
- • Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Up to approximately 60 months)
- • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395 (Up to approximately 60 months)
- • Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395 (Up to approximately 60 months)
Sponsor
BeOne Medicines · industry
Contacts & investigators
ContactStudy Director · contact · clinicaltrials@beonemed.com · 1.877.828.5568
InvestigatorStudy Director · study_director, BeOne Medicines
All locations (63)
Sarah Cannon Research Institute (Scri) At Health OneRecruiting
Denver, Colorado, United States
Florida Cancer Specialists and Research InstituteCompleted
Lake Mary, Florida, United States
Karmanos Cancer InstituteCompleted
Detroit, Michigan, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Duke Cancer CenterRecruiting
Durham, North Carolina, United States
James Cancer Hospital and Solove Research InstituteRecruiting
Columbus, Ohio, United States
Scri Oncology PartnersRecruiting
Nashville, Tennessee, United States
The University of Texas Md Anderson Cancer CenterRecruiting
Houston, Texas, United States
Next DallasRecruiting
Irving, Texas, United States
Next OncologyRecruiting
San Antonio, Texas, United States
Blacktown Cancer and Haematology CentreRecruiting
Blacktown, New South Wales, Australia
Southern Highlands Private HospitalRecruiting
Bowral, New South Wales, Australia
Concord Repatriation General HospitalRecruiting
Concord, New South Wales, Australia
Macquarie UniversityRecruiting
North Ryde, New South Wales, Australia
Townsville University HospitalRecruiting
Douglas, Queensland, Australia
Genesiscare St AndrewsRecruiting
Adelaide, South Australia, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
Peter Maccallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Fundacao Pio Xii Hospital de Amor de BarretosRecruiting
Barretos, Brazil
Hospital Sirio Libanes BrasiliaRecruiting
Brasília, Brazil
Centro de Pesquisas Oncologicas CeponRecruiting
Florianópolis, Brazil
Liga Norte Riograndene Contra O CancerRecruiting
Natal, Brazil
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em SaudeRecruiting
Petrópolis, Brazil
Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E AssistenciaRecruiting
Porto Algre, Brazil
Instituto Nacional de CancerRecruiting
Rio de Janeiro, Brazil
Instituto Dor de Pesquisa E Ensino Hospital Sao RafaelRecruiting
Salvador, Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de OliveiraRecruiting
São Paulo, Brazil
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E MamariaRecruiting
São Paulo, Brazil
Hospital Israelita Albert EinsteinRecruiting
São Paulo, Brazil
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
Fujian Cancer HospitalRecruiting
Fuzhou, Fujian, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)Recruiting
Guangzhou, Guangdong, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, Heilongjiang, China
The First Affiliated Hospital of Nanchang University Branch DonghuRecruiting
Nanchang, Jiangxi, China
Liaoning Cancer Hospital and InstituteRecruiting
Shenyang, Liaoning, China
Fudan University Shanghai Cancer CenterpudongRecruiting
Shanghai, Shanghai Municipality, China
Centre de Lutte Contre Le Cancer Institut BergonieRecruiting
Bordeaux, France
Centre Francois BaclesseRecruiting
Caen, France
Centre Oscar LambretRecruiting
Lille, France
Institut Paoli CalmettesRecruiting
Marseille, France
Institut CurieRecruiting
Paris, France
Centre Eugene MarquisRecruiting
Rennes, France
Institut de Cancerologie de LouestRecruiting
Saint-Herblain, France
Institut Gustave RoussyRecruiting
Villejuif, France
Nagoya University HospitalRecruiting
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital EastRecruiting
Kashiwa, Chiba, Japan
Shizuoka Cancer CenterRecruiting
Suntogun, Shizuoka, Japan
Pulau Pinang HospitalRecruiting
George Town, Malaysia
University Malaya Medical CentreRecruiting
Kuala Lumpur, Malaysia
Sarawak General HospitalRecruiting
Kuching, Malaysia
National Cancer Institute (Institut Kanser Negara)Recruiting
Putrajaya, Malaysia
The Institute of Oncology, Arensia Exploratory MedicineActive Not Recruiting
Chisinau, Moldova
Harbour Cancer and WellnessRecruiting
Auckland, New Zealand
Nzcr ChristchurchRecruiting
Christchurch, New Zealand
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea
Gachon University Gil Medical CenterRecruiting
NamdongGu, Incheon Gwang'yeogsi, South Korea
Samsung Medical CenterRecruiting
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys HospitalRecruiting
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Korea University Anam HospitalRecruiting
SeongbukGu, Seoul Teugbyeolsi, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical CenterRecruiting
SongpaGu, Seoul Teugbyeolsi, South Korea
Srinagarind Hospital (Khon Kaen University)Active Not Recruiting
Muang, Thailand