> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/bgb-43395-alone-or-as-part-of-combination-therapies-in-7911d36e-b7ad-48e1-98d0-ccaa83a2f342 > Record changed: 2026-10-13 # BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors NCT06120283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) Participants 433 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) Lead sponsor BeOne Medicines Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) Start date 2023-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) Number of sites 62 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Short title** BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Dates **Completion date** 2029-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **First posted** 2023-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Primary completion date** 2029-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Start date** 2023-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Size and sites **Participants** 433 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Planned participants** 433 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Number of sites** 62 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Lead sponsor** BeOne Medicines Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Identifiers **Registry ID** NCT06120283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **ClinicalTrials.gov ID** NCT06120283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Outcomes ### Primary outcomes 1. Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: Up to approximately 60 months Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria. 2. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395 Timeframe: Up to approximately 60 months MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 28%. MAD is defined as the highest dose administered if MTD is not reached. 3. Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395 Timeframe: Up to approximately 60 months RDFE of BGB-43395 alone or in combination with fulvestrant, letrozole, or elacestrant will be determined based upon the MTD or MAD. 4. Phase 1b: Objective Response Rate (ORR) Timeframe: Up to approximately 60 months ORR is defined as the percentage of participants who have confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. ### Secondary outcomes 1. Phase 1a: ORR Timeframe: Up to approximately 60 months ORR is defined as the percentage of participants who have confirmed CR or PR assessed by the investigator using RECIST v1.1. 2. Phase 1a and 1b: Duration of Response (DOR) Timeframe: Up to approximately 60 months DOR is defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator. 3. Phase 1a and 1b: Time to Response (TTR) Timeframe: Up to approximately 60 months TTR is defined as the time from the date of the first dose of study drugs to the date of the first determination of objective response by the investigator using RECIST v1.1. 4. Phase 1b: Disease Control Rate (DCR) Timeframe: Up to approximately 60 months DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease assessed by the investigator using RECIST v1.1. 5. Phase 1b: Clinical Benefit Rate (CBR) Timeframe: Up to approximately 60 months CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks. 6. Phase 1b: Progression-Free Survival (PFS) Timeframe: Up to approximately 60 months PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first. 7. Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: Up to approximately 60 months Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments. 8. Phase 1a: Observed Plasma Maximum Concentration (Cmax) of BGB-43395 and its metabolite Timeframe: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days) 9. Phase 1a: Observed Plasma Trough Concentration (Ctrough) of BGB-43395 and its metabolite Timeframe: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days) 10. Phase 1a: Area under the concentration-time curve (AUC) of BGB-43395 and its metabolite Timeframe: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days) 11. Phase 1a: Half-life (t1/2) of BGB-43395 and its metabolite Timeframe: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days) 12. Phase 1b: Plasma concentrations of BGB-43395 and its metabolite Timeframe: From Cycle 1 Day 1 up to Cycle 5 Day 1 (each cycle is 28 days) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Sites - Sarah Cannon Research Institute (Scri) At Health OneDenver, United StatesRecruiting - Florida Cancer Specialists and Research InstituteLake Mary, United StatesCompleted - Karmanos Cancer InstituteDetroit, United StatesCompleted - Washington University School of MedicineSt Louis, United StatesRecruiting - Duke Cancer CenterDurham, United StatesRecruiting - James Cancer Hospital and Solove Research InstituteColumbus, United StatesRecruiting - Scri Oncology PartnersNashville, United StatesRecruiting - The University of Texas Md Anderson Cancer CenterHouston, United StatesRecruiting - Next DallasIrving, United StatesRecruiting - Next OncologySan Antonio, United StatesRecruiting - Blacktown Cancer and Haematology CentreBlacktown, AustraliaRecruiting - Southern Highlands Private HospitalBowral, AustraliaRecruiting - Concord Repatriation General HospitalConcord, AustraliaRecruiting - Macquarie UniversityNorth Ryde, AustraliaRecruiting - Townsville University HospitalDouglas, AustraliaRecruiting - Genesiscare St AndrewsAdelaide, AustraliaRecruiting - Austin HealthHeidelberg, AustraliaCompleted - Peter Maccallum Cancer CentreMelbourne, AustraliaRecruiting - Fundacao Pio Xii Hospital de Amor de BarretosBarretos, BrazilRecruiting - Hospital Sirio Libanes BrasiliaBrasília, BrazilRecruiting - Centro de Pesquisas Oncologicas CeponFlorianópolis, BrazilRecruiting - Liga Norte Riograndene Contra O CancerNatal, BrazilRecruiting - Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em SaudePetrópolis, BrazilRecruiting - Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E AssistenciaPorto Algre, BrazilRecruiting - Instituto Nacional de CancerRio de Janeiro, BrazilRecruiting And 37 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## References ### Other registry identifiers (3) - 2023 - 2023-506888-34-00 - CTR20243370 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06120283) ## Related records ### Drugs (4) - [Anti-melanoma mab fragments](https://trialight.com/data/asset/anti-melanoma-mab-fragments-abef3d43-ce8d-4999-b59c-dad5d3bfda00.md) - [Elacestrant hydrochloride](https://trialight.com/data/asset/elacestrant-hydrochloride-13959fda-16a0-4471-b7ed-8c2cda471800.md) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) - [Letrozole](https://trialight.com/data/asset/letrozole-67319198-7e88-4130-b185-d776c835863c.md) ### Lead sponsors (1) - [BeOne Medicines](https://trialight.com/data/company/beone-medicines-ca965972-7362-4484-b43f-72a02fc75941.md) ### Conditions (3) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Hormone receptor-positive breast cancer](https://trialight.com/data/condition/hormone-receptor-positive-breast-cancer-1615b277-fa91-513c-addf-371a0c1fe840.md) ### Targets (2) - [CYP19A1](https://trialight.com/data/target/cyp19a1-9682b33b-ed66-55a7-8155-bf00584059c7.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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