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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523165-19-00 | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.
This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy | Experimental | Sequential cohorts of increasing dose levels of BG-75098 will be evaluated as monotherapy. |
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| Phase 1a, Part B: Dose Escalation, BG-75098 Combination | Experimental | Sequential cohorts of increasing dose levels of BG-75098 will be evaluated in combination with BGB-43395 and fulvestrant. |
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| Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination | Experimental | Participants will receive BG-75098 at the recommended dose level from Phase 1a in combination with BGB-43395 and fulvestrant. |
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| Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy | Experimental | Participants will receive BG-75098 as monotherapy at the recommended dose level from Phase 1a. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG-75098 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Number of Participants with Adverse Events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria. | From first dose to 30 days after last dose, up to approximately 12 months |
| Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-75098 | MTD is determined based on a target for dose-limiting toxicities. MAD is defined as the maximum administered dose, and it is used when MTD is not reached. | Up to approximately 2 years |
| Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-75098 as Monotherapy and in Combination with BGB-43395 and Fulvestrant | The RDFE(s) will be determined from safety, tolerability, pharmacokinetic, pharmacodynamic biomarker(s), preliminary antitumor activity, and any other relevant data that are obtained from the dose escalation phase. | Up to approximately 2 years |
| Phase 1b: Objective Response Rate (ORR) as Assessed by the Investigator | ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator using RECIST v1.1. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: ORR as Assessed by the Investigator | ORR is defined as the percentage of participants with best overall response of CR or PR, as assessed by the investigator using RECIST v1.1. | Up to approximately 2 years |
| Phase 1a: Duration of Response (DOR) as Assessed by the Investigator |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 8778285568 | clinicaltrials@beonemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeOne Medicines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham Hospital | Recruiting | Birmingham | Alabama | 35294-0004 | United States | |
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See plan description
See plan description
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| BGB-43395 | Drug | Administered orally. |
|
| Fulvestrant | Drug | Administered by intramuscular injection. |
|
DOR is defined as the time from the first confirmed objective response assessed by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first. |
| Up to approximately 2 years |
| Phase 1a: Time to Response (TTR) as Assessed by the Investigator | TTR is defined as the time from treatment initiation to the first determination of overall response assessed by the investigator using RECIST v1.1. | Up to approximately 2 years |
| Phase 1a: Progression-Free Survival (PFS) as Assessed by the Investigator | PFS is defined as the time from the date of the first dose of study treatment to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first. | Up to approximately 2 years |
| Phase 1b: DOR as Assessed by the Investigator | DOR is defined as the time from the first confirmed objective response assessed by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first. | Up to approximately 2 years |
| Phase 1b: TTR as Assessed by the Investigator | TTR is defined as the time from treatment initiation to the first determination of overall response assessed by the investigator using RECIST v1.1. | Up to approximately 2 years |
| Phase 1b: Disease Control Rate (DCR) | DCR is defined as the percentage of participants with a best overall response, of CR, PR, or stable disease assessed by the investigator using RECIST v1.1. | Up to approximately 2 years |
| Phase 1b: Clinical Benefit Rate (CBR) | CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks. | Up to approximately 2 years |
| Phase 1b: PFS | PFS is defined as the time from the date of the first dose of study treatment to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first. | Up to approximately 2 years |
| Phase 1b: Number of Participants with AEs | Number of participants with TEAEs and SAEs, including physical examination findings, electrocardiogram results, and laboratory values. | Up to approximately 2 years |
| Observed Plasma Maximum Concentration (Cmax) of BG-75098 | Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days) |
| Observed Plasma Trough Concentration (Ctrough) of BG-75098 | Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days) |
| Area Under the Concentration-Time Curve (AUC) of BG-75098 | Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days) |
| Terminal Half-Life (t1/2) of BG-75098 | Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days) |
| Phase 1b: Plasma Concentrations of BG-75098 | Assessed at select time points between Cycle 1 and Cycle 7 (each Cycle is 28 days) |
| Phase 1a: Observed Plasma Maximum Concentration (Cmax) of BGB-43395 | Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days) |
| Phase 1a: Observed Plasma Trough Concentration (Ctrough) of BGB-43395 | Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days) |
| Phase 1a: Area Under the Concentration-Time Curve (AUC) of BGB-43395 | Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days) |
| Phase 1a: Terminal Half-Life (t1/2) of BGB-43395 | Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days) |
| Plasma Concentrations of BGB-43395 | Assessed at select time points between Cycle 1 and Cycle 7 (each Cycle is 28 days) |
| Yale Cancer Center |
| Recruiting |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Sidney Kimmel Comprehensive Cancer At Johns Hopkins | Recruiting | Baltimore | Maryland | 21287 | United States |
| The University of Texas Md Anderson Cancer Center | Recruiting | Houston | Texas | 77030-4009 | United States |
| Next Houston | Recruiting | Houston | Texas | 77054 | United States |
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226-3522 | United States |
| Blacktown Cancer and Haematology Centre | Recruiting | Blacktown | New South Wales | NSW 2148 | Australia |
| Genesiscare St Leonards | Recruiting | St Leonards | New South Wales | NSW 2065 | Australia |
| Icon Cancer Centre Wesley | Recruiting | Auchenflower | Queensland | QLD 4066 | Australia |
| Cabrini Hospital Malvern | Recruiting | Malvern | Victoria | VIC 3144 | Australia |
| Peter Maccallum Cancer Centre | Recruiting | Melbourne | Victoria | VIC 3000 | Australia |
| One Clinical Research | Recruiting | Nedlands | Western Australia | WA 6009 | Australia |
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) | Recruiting | Guangzhou | Guangdong | 510245 | China |
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150000 | China |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch | Recruiting | Wuhan | Hubei | 430048 | China |
| Jiangsu Province Hospital Longjiang Branch | Recruiting | Nanjing | Jiangsu | 210036 | China |
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250000 | China |
| Weifang Peoples Hospital | Recruiting | Weifang | Shandong | 261000 | China |
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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