Actively Recruiting
A Phase 1a/1b Study Investigating Safety, Dosing, and Antitumor Activity of BGB-43395 Alone or with Fulvestrant, Letrozole, or Elacestrant in Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Led by BeOne Medicines · Updated on 2026-05-27
399
Participants Needed
63
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and dosing of BGB-43395, a selective CDK4 inhibitor, alone or combined with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and HER2-negative breast cancer as well as other advanced solid tumors. The study aims to find the recommended dose of BGB-43395 and assess its tolerability and antitumor activity. This Phase 1a/1b trial is sponsored by BeOne Medicines and includes dose escalation and expansion phases to evaluate different dosing levels and combinations. The trial includes sequential cohorts receiving increasing doses of BGB-43395 as monotherapy and combined with fulvestrant, letrozole, or elacestrant. In Phase 1a, doses are tested for safety and tolerability. Phase 1b focuses on evaluating the recommended dose for expansion, especially in combination with fulvestrant or letrozole in HR+ breast cancer. Some participants receiving letrozole will also take an anti-diarrheal agent to prevent diarrhea. BGB-43395 and the other drugs are given orally or by intramuscular injection depending on the drug. Participants will undergo safety monitoring for adverse events, pharmacokinetic testing, and tumor response assessments over up to about 60 months. Blood samples will be collected to measure drug levels and effects. Researchers will track response rates, duration of response, disease control, and progression-free survival. Participants must have stable health status and adequate organ function. The study includes careful follow-ups to evaluate safety and effectiveness of the dosing regimens in advanced breast cancer and other solid tumors.
CONDITIONS
Brief Title
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Participants with confirmed advanced, metastatic, or unresectable solid tumors dependent on CDK4 including HR+ breast cancer, ovarian, endometrial, or non-small cell lung cancer
- For combination with elacestrant, prior treatment including endocrine therapy and CDK4/6 inhibitor required
- For combination with fulvestrant, prior endocrine therapy and CDK4/6 inhibitor required (Phase 1a Safety Expansion)
- For combination with letrozole, must be CDK4/6 inhibitor treatment naive and no prior systemic treatment for advanced disease
- Participants with HR+/HER2- breast cancer in Phase 1b
- Female participants must be postmenopausal or receiving ovarian suppression treatment
- Stable ECOG performance status of 0 or 1
- Adequate organ function without symptomatic visceral disease
You will not qualify if you...
- Known leptomeningeal disease or untreated, uncontrolled brain metastases
- Any other malignancy within 3 years before first study dose except the cancer under study or treated local recurrences
- Uncontrolled diabetes
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 28 days before first study dose or symptomatic COVID-19
- Untreated chronic hepatitis B or carriers with high HBV DNA levels
- Active hepatitis C infection
- Prior allogeneic stem cell or organ transplantation
- Other protocol defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 60 months
Participants receive planned doses of BGB-43395 alone or in combination with fulvestrant, letrozole, or elacestrant to assess safety and dosing.
Visits occur each 28-day cycle from Cycle 1 Day 1 up to Cycle 7 Day 1
Duration - Up to approximately 60 months
Participants continue receiving BGB-43395 alone or in combination with fulvestrant, letrozole, or elacestrant, with some participants also receiving an anti-diarrheal agent for prophylaxis.
Visits occur each 28-day cycle from Cycle 1 Day 1 up to Cycle 5 Day 1
Duration - Up to approximately 60 months
Participants are monitored for safety and antitumor activity after treatment completion.
Visit frequency depends on individual treatment phase and cohort assignment
Trial Site Locations
Total: 63 locations
1
Sarah Cannon Research Institute (Scri) At Health One
Denver, Colorado, United States, 80218-1238
Actively Recruiting
2
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, United States, 32746-2115
Completed
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-2013
Completed
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
5
Duke Cancer Center
Durham, North Carolina, United States, 27710-2000
Actively Recruiting
6
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210-1240
Actively Recruiting
7
Scri Oncology Partners
Nashville, Tennessee, United States, 37203-1503
Actively Recruiting
8
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Actively Recruiting
9
Next Dallas
Irving, Texas, United States, 75039-2743
Actively Recruiting
10
Next Oncology
San Antonio, Texas, United States, 78229-6028
Actively Recruiting
11
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia, NSW 2148
Actively Recruiting
12
Southern Highlands Private Hospital
Bowral, New South Wales, Australia, NSW 2576
Actively Recruiting
13
Concord Repatriation General Hospital
Concord, New South Wales, Australia, NSW 2139
Actively Recruiting
14
Macquarie University
North Ryde, New South Wales, Australia, NSW 2109
Actively Recruiting
15
Townsville University Hospital
Douglas, Queensland, Australia, QLD 4814
Actively Recruiting
16
Genesiscare St Andrews
Adelaide, South Australia, Australia, SA 5000
Actively Recruiting
17
Austin Health
Heidelberg, Victoria, Australia, VIC 3084
Actively Recruiting
18
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, VIC 3000
Actively Recruiting
19
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, Brazil, 14.784-400
Actively Recruiting
20
Hospital Sirio Libanes Brasilia
Brasília, Brazil, 70200-730
Actively Recruiting
21
Centro de Pesquisas Oncologicas Cepon
Florianópolis, Brazil, 88034-000
Actively Recruiting
22
Liga Norte Riograndene Contra O Cancer
Natal, Brazil, 59062-000
Actively Recruiting
23
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
Petrópolis, Brazil, 95070-560
Actively Recruiting
24
Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia
Porto Algre, Brazil, 90610-000
Actively Recruiting
25
Instituto Nacional de Cancer
Rio de Janeiro, Brazil, 20560-120
Actively Recruiting
26
Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael
Salvador, Brazil, 41253-190
Actively Recruiting
27
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, Brazil, 01246-000
Actively Recruiting
28
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
São Paulo, Brazil, 01318-001
Actively Recruiting
29
Hospital Israelita Albert Einstein
São Paulo, Brazil, 05652-900
Actively Recruiting
30
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
31
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
32
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China, 510245
Actively Recruiting
33
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
34
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China, 330006
Actively Recruiting
35
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China, 110042
Actively Recruiting
36
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
37
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, France, 33000
Actively Recruiting
38
Centre Francois Baclesse
Caen, France, 14000
Actively Recruiting
39
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
40
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
41
Institut Curie
Paris, France, 75005
Actively Recruiting
42
Centre Eugene Marquis
Rennes, France, 35043
Actively Recruiting
43
Institut de Cancerologie de Louest
Saint-Herblain, France, 44800
Actively Recruiting
44
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
45
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
Actively Recruiting
46
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
47
Shizuoka Cancer Center
Suntogun, Shizuoka, Japan, 411-8777
Actively Recruiting
48
Pulau Pinang Hospital
George Town, Malaysia, 10450
Actively Recruiting
49
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
50
Sarawak General Hospital
Kuching, Malaysia, 93586
Actively Recruiting
51
National Cancer Institute (Institut Kanser Negara)
Putrajaya, Malaysia, 62250
Actively Recruiting
52
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, Moldova, 2025
Actively Recruiting
53
Harbour Cancer and Wellness
Auckland, New Zealand, 1023
Actively Recruiting
54
Nzcr Christchurch
Christchurch, New Zealand, 8011
Actively Recruiting
55
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
56
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi, South Korea, 21565
Actively Recruiting
57
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
58
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
Actively Recruiting
59
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
60
Korea University Anam Hospital
SeongbukGu, Seoul Teugbyeolsi, South Korea, 02841
Actively Recruiting
61
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
62
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
63
Srinagarind Hospital (Khon Kaen University)
Muang, Thailand, 40002
Active, Not Recruiting
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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