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

Status: Recruiting
Location: See all (63) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Phase 1a (Dose Escalation) and 1b (Dose Expansion): 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.

• 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.

Locations
United States
Colorado
Sarah Cannon Research Institute (Scri) At Health One
RECRUITING
Denver
Florida
Florida Cancer Specialists and Research Institute
RECRUITING
Lake Mary
Michigan
Karmanos Cancer Institute
COMPLETED
Detroit
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Duke Cancer Center
RECRUITING
Durham
Ohio
James Cancer Hospital and Solove Research Institute
RECRUITING
Columbus
Tennessee
Scri Oncology Partners
RECRUITING
Nashville
Texas
Next Oncology
RECRUITING
Austin
The University of Texas Md Anderson Cancer Center
RECRUITING
Houston
Next Dallas
RECRUITING
Irving
Other Locations
Australia
Genesiscare St Andrews
RECRUITING
Adelaide
Blacktown Cancer and Haematology Centre
RECRUITING
Blacktown
Southern Highlands Private Hospital
RECRUITING
Bowral
Concord Repatriation General Hospital
RECRUITING
Concord
Townsville University Hospital
RECRUITING
Douglas
Austin Health
RECRUITING
Heidelberg
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
Macquarie University
RECRUITING
North Ryde
Brazil
Fundacao Pio Xii Hospital de Amor de Barretos
RECRUITING
Barretos
Hospital Sirio Libanes Brasilia
RECRUITING
Brasília
Centro de Pesquisas Oncologicas Cepon
RECRUITING
Florianópolis
Liga Norte Riograndene Contra O Cancer
RECRUITING
Natal
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
RECRUITING
Petrópolis
Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia
RECRUITING
Porto Algre
Instituto Nacional de Cancer
RECRUITING
Rio De Janeiro
Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael
RECRUITING
Salvador
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
RECRUITING
São Paulo
Hospital Israelita Albert Einstein
RECRUITING
São Paulo
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
RECRUITING
São Paulo
China
Beijing Cancer Hospital
RECRUITING
Beijing
Fujian Cancer Hospital
RECRUITING
Fuzhou
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
RECRUITING
Guangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The First Affiliated Hospital of Nanchang University Branch Donghu
RECRUITING
Nanchang
Fudan University Shanghai Cancer Centerpudong
RECRUITING
Shanghai
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
France
Centre de Lutte Contre Le Cancer Institut Bergonie
RECRUITING
Bordeaux
Centre Francois Baclesse
RECRUITING
Caen
Centre Oscar Lambret
RECRUITING
Lille
Institut Paoli Calmettes
RECRUITING
Marseille
Institut Curie
RECRUITING
Paris
Centre Eugene Marquis
RECRUITING
Rennes
Institut de Cancerologie de Louest
RECRUITING
Saint-herblain
Institut Gustave Roussy
RECRUITING
Villejuif
Japan
National Cancer Center Hospital East
RECRUITING
Kashiwa
Nagoya University Hospital
RECRUITING
Nagoya
Shizuoka Cancer Center
RECRUITING
Suntogun
Malaysia
Pulau Pinang Hospital
RECRUITING
George Town
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Sarawak General Hospital
RECRUITING
Kuching
National Cancer Institute (Institut Kanser Negara)
RECRUITING
Putrajaya
New Zealand
Harbour Cancer and Wellness
RECRUITING
Auckland
Nzcr Christchurch
RECRUITING
Christchurch
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Bundanggu Seongnamsi
Samsung Medical Center
RECRUITING
Gangnamgu
Gachon University Gil Medical Center
RECRUITING
Namdonggu
The Catholic University of Korea, Seoul St Marys Hospital
RECRUITING
Seochogu
Severance Hospital Yonsei University Health System
RECRUITING
Seodaemungu
Korea University Anam Hospital
RECRUITING
Seongbukgu
Seoul National University Hospital
RECRUITING
Seoul
Asan Medical Center
RECRUITING
Songpagu
Republic of Moldova
The Institute of Oncology, Arensia Exploratory Medicine
RECRUITING
Chisinau
Thailand
Srinagarind Hospital (Khon Kaen University)
ACTIVE_NOT_RECRUITING
Muang
Contact Information
Primary
Study Director
clinicaltrials@beigene.com
1.877.828.5568
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2028-06
Participants
Target number of participants: 300
Treatments
Experimental: 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.
Experimental: 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.
Sponsors
Leads: BeiGene

This content was sourced from clinicaltrials.gov

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