NCT06120283From ClinicalTrials.govRecruiting

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

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

Advanced Solid Tumor
Advanced Breast Cancer
Metastatic Breast Cancer
Hormone-receptor-positive Breast Cancer
Hormone Receptor Positive Breast Carcinoma
Hormone Receptor Positive Malignant Neoplasm of Breast
HER2-negative Breast Cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: BeOne Medicines
Enrolment target: 433
Started: 1 December 2023
Main results due: December 2029
Study sites: 61
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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. 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(61)

Sarah Cannon Research Institute (Scri) At Health One
Denver, Colorado, United States
Recruiting
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, United States
Completed
Karmanos Cancer Institute
Detroit, Michigan, United States
Completed
Duke Cancer Center
Durham, North Carolina, United States
Recruiting
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Recruiting
Scri Oncology Partners
Nashville, Tennessee, United States
Recruiting
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Recruiting
Next Oncology Dallas
Irving, Texas, United States
Recruiting
Next Oncology
San Antonio, Texas, United States
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Recruiting
Southern Highlands Private Hospital
Bowral, New South Wales, Australia
Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Recruiting
Macquarie University
North Ryde, New South Wales, Australia
Recruiting
Townsville University Hospital
Douglas, Queensland, Australia
Recruiting
Genesiscare St Andrews
Adelaide, South Australia, Australia
Recruiting
Austin Health
Heidelberg, Victoria, Australia
Completed
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Recruiting
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, Brazil
Recruiting
Hospital Sirio Libanes Brasilia
Brasília, Brazil
Recruiting
Centro de Pesquisas Oncologicas Cepon
Florianópolis, Brazil
Recruiting
Liga Norte Riograndene Contra O Cancer
Natal, Brazil
Recruiting
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
Petrópolis, Brazil
Recruiting
Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia
Porto Algre, Brazil
Recruiting
Instituto Nacional de Cancer
Rio de Janeiro, Brazil
Recruiting
Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael
Salvador, Brazil
Recruiting
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, Brazil
Recruiting
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
São Paulo, Brazil
Recruiting
Hospital Israelita Albert Einstein
São Paulo, Brazil
Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, China
Recruiting
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China
Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Recruiting
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Recruiting
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Recruiting
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, China
Recruiting
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, France
Recruiting
Centre Francois Baclesse
Caen, France
Recruiting
Centre Oscar Lambret
Lille, France
Recruiting
Institut Paoli Calmettes
Marseille, France
Recruiting
Institut Curie
Paris, France
Recruiting
Centre Eugene Marquis
Rennes, France
Recruiting
Institut de Cancerologie de Louest
Saint-Herblain, France
Recruiting
Institut Gustave Roussy
Villejuif, France
Recruiting
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Recruiting
Shizuoka Cancer Center
Suntogun, Shizuoka, Japan
Recruiting
Pulau Pinang Hospital
George Town, Malaysia
Recruiting
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Recruiting
Sarawak General Hospital
Kuching, Malaysia
Recruiting
National Cancer Institute (Institut Kanser Negara)
Putrajaya, Malaysia
Recruiting
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, Moldova
Recruiting
Harbour Cancer and Wellness
Auckland, New Zealand
Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Recruiting
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'Yeogsi, South Korea
Recruiting
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
Recruiting
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Recruiting
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Recruiting
Korea University Anam Hospital
SeongbukGu, Seoul Teugbyeolsi, South Korea
Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Recruiting
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Recruiting

Showing 60 of 61 sites — filter to narrow it down. 57 of the 61 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06120283. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me