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New hope for Hard-to-Treat breast cancer: targeted drug trial begins

NCT ID NCT06120283

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 9 times

Summary

This early-phase study tests a new drug called BGB-43395 in people with advanced HR+/HER2- breast cancer and other solid tumors. The drug blocks a protein (CDK4) that helps cancer cells grow. Researchers want to find the safest and most effective dose, either alone or combined with other treatments. About 399 participants will join to check safety, side effects, and early signs of tumor shrinkage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 433 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm endometrial cancer Her2-receptor negative breast cancer hormone receptor-positive breast cancer neoplasm non-small cell lung carcinoma ovarian cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer Advanced solid tumor HER2-negative breast cancer Hormone receptor positive HER-2 negative breast cancer Hormone receptor positive malignant neoplasm of breast Hormone receptor-positive breast cancer Hormone receptor-positive breast carcinoma Metastatic breast cancer Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    58 sites in 10 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center

    RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Austin Health

    COMPLETED

    Heidelberg, Victoria, VIC 3084, Australia

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Blacktown Cancer and Haematology Centre

    RECRUITING

    Blacktown, New South Wales, NSW 2148, Australia

  • Centre Eugene Marquis

    RECRUITING

    Rennes, 35043, France

  • Centre Francois Baclesse

    RECRUITING

    Caen, 14000, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59000, France

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    RECRUITING

    Bordeaux, 33076, France

  • Centro de Pesquisas Oncologicas Cepon

    RECRUITING

    Florianópolis, 88034-000, Brazil

  • Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria

    RECRUITING

    São Paulo, 01318-001, Brazil

  • Concord Repatriation General Hospital

    RECRUITING

    Concord, New South Wales, NSW 2139, Australia

  • Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710-2000, United States

  • Florida Cancer Specialists and Research Institute

    COMPLETED

    Lake Mary, Florida, 32746-2115, United States

  • Fudan University Shanghai Cancer Centerpudong

    RECRUITING

    Shanghai, Shanghai Municipality, 201321, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fundacao Pio Xii Hospital de Amor de Barretos

    RECRUITING

    Barretos, 14.784-400, Brazil

  • Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude

    RECRUITING

    Petrópolis, 95070-560, Brazil

  • Gachon University Gil Medical Center

    RECRUITING

    NamdongGu, Incheon Gwang'Yeogsi, 21565, South Korea

  • Genesiscare St Andrews

    RECRUITING

    Adelaide, South Australia, SA 5000, Australia

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Harbour Cancer and Wellness

    RECRUITING

    Auckland, 1023, New Zealand

  • Hospital Israelita Albert Einstein

    RECRUITING

    São Paulo, 05652-900, Brazil

  • Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia

    RECRUITING

    Porto Algre, 90610-000, Brazil

  • Hospital Sirio Libanes Brasilia

    RECRUITING

    Brasília, 70200-730, Brazil

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Institut Curie

    RECRUITING

    Paris, 75005, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13009, France

  • Institut de Cancerologie de Louest

    RECRUITING

    Saint-Herblain, 44800, France

  • Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael

    RECRUITING

    Salvador, 41253-190, Brazil

  • Instituto Nacional de Cancer

    RECRUITING

    Rio de Janeiro, 20560-120, Brazil

  • James Cancer Hospital and Solove Research Institute

    RECRUITING

    Columbus, Ohio, 43210-1240, United States

  • Karmanos Cancer Institute

    COMPLETED

    Detroit, Michigan, 48201-2013, United States

  • Korea University Anam Hospital

    RECRUITING

    SeongbukGu, Seoul Teugbyeolsi, 02841, South Korea

  • Liaoning Cancer Hospital and Institute

    RECRUITING

    Shenyang, Liaoning, 110042, China

  • Liga Norte Riograndene Contra O Cancer

    RECRUITING

    Natal, 59062-000, Brazil

  • Macquarie University

    RECRUITING

    North Ryde, New South Wales, NSW 2109, Australia

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • National Cancer Institute (Institut Kanser Negara)

    RECRUITING

    Putrajaya, 62250, Malaysia

  • Next Oncology

    RECRUITING

    San Antonio, Texas, 78229-6028, United States

  • Next Oncology Dallas

    RECRUITING

    Irving, Texas, 75039-2743, United States

  • Peter Maccallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, VIC 3000, Australia

  • Pulau Pinang Hospital

    RECRUITING

    George Town, 10450, Malaysia

  • Samsung Medical Center

    RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Sarah Cannon Research Institute (Scri) At Health One

    RECRUITING

    Denver, Colorado, 80218-1238, United States

  • Sarawak General Hospital

    RECRUITING

    Kuching, 93586, Malaysia

  • Scri Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203-1503, United States

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shizuoka Cancer Center

    RECRUITING

    Suntogun, Shizuoka, 411-8777, Japan

  • Southern Highlands Private Hospital

    RECRUITING

    Bowral, New South Wales, NSW 2576, Australia

  • Srinagarind Hospital (Khon Kaen University)

    ACTIVE_NOT_RECRUITING

    Muang, 40002, Thailand

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

    RECRUITING

    Guangzhou, Guangdong, 510245, China

  • The Catholic University of Korea, Seoul St Marys Hospital

    RECRUITING

    SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The Institute of Oncology, Arensia Exploratory Medicine

    RECRUITING

    Chisinau, 2025, Moldova

  • The University of Texas Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4009, United States

  • Townsville University Hospital

    RECRUITING

    Douglas, Queensland, QLD 4814, Australia

  • University Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

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