BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Recruiting · NCT06120283 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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. 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.
Where it is running
60 locations listed across 8 US states.
- 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
- The University of Texas Md Anderson Cancer Center - Houston, Texas, United States
- Next Oncology Dallas - Irving, Texas, United States
- Next Oncology - San Antonio, Texas, United States
- Harbour Cancer and Wellness - Auckland, New Zealand
- Fundacao Pio Xii Hospital de Amor de Barretos - Barretos, Brazil
- Centre de Lutte Contre Le Cancer Institut Bergonie - Bordeaux, France
- Hospital Sirio Libanes Brasilia - Brasília, Brazil
- Centre Francois Baclesse - Caen, France
- The Institute of Oncology, Arensia Exploratory Medicine - Chisinau, Moldova
- Centro de Pesquisas Oncologicas Cepon - Florianópolis, Brazil
- Pulau Pinang Hospital - George Town, Malaysia
- University Malaya Medical Centre - Kuala Lumpur, Malaysia
- Sarawak General Hospital - Kuching, Malaysia
- Centre Oscar Lambret - Lille, France
- Institut Paoli Calmettes - Marseille, France
- Srinagarind Hospital (Khon Kaen University) - Muang, Thailand
- Liga Norte Riograndene Contra O Cancer - Natal, Brazil
- Institut Curie - Paris, France
- 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
- National Cancer Institute (Institut Kanser Negara) - Putrajaya, Malaysia
- Centre Eugene Marquis - Rennes, France
- Instituto Nacional de Cancer - Rio de Janeiro, Brazil
- Institut de Cancerologie de Louest - Saint-Herblain, France
- 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
- Institut Gustave Roussy - Villejuif, France
- Nagoya University Hospital - Nagoya, Aichi-ken, Japan
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China
- National Cancer Center Hospital East - Kashiwa, Chiba, Japan
- Fujian Cancer Hospital - Fuzhou, Fujian, China
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) - Guangzhou, Guangdong, China
- Seoul National University Bundang Hospital - Seongnam-si, Gyeonggi-do, South Korea
- Harbin Medical University Cancer Hospital - Harbin, Heilongjiang, China
- Gachon University Gil Medical Center - NamdongGu, Incheon Gwang'Yeogsi, South Korea
- The First Affiliated Hospital of Nanchang University Branch Donghu - Nanchang, Jiangxi, China
- Liaoning Cancer Hospital and Institute - Shenyang, Liaoning, China
- 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
- 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
- Fudan University Shanghai Cancer Centerpudong - Shanghai, Shanghai Municipality, China
- Shizuoka Cancer Center - Suntogun, Shizuoka, Japan
- Genesiscare St Andrews - Adelaide, South Australia, Australia
Showing 60 of 62 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →