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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523553-34-00 | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A/B inhibitor) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy | Experimental | Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy. |
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| Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist | Experimental | Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist. |
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| Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist | Experimental | Participants will receive BG-75202 in combination with an estrogen receptor antagonist. |
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| Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor | Experimental | Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor. |
|
| Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG-75202 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: 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 or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months |
| Part 1: Recommended Dose for Expansion (RDFE) | The RDFE is based on the maximum tolerated dose (MTD) or maximum administered dose (MAD) with consideration of the tolerability, pharmacokinetics (PK), pharmacodynamics, antitumor activity, and any other available relevant data. | Estimated approximately 1 year |
| Part 2: Overall Response Rate (ORR) | ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: ORR | ORR is defined as the percentage of participants with partial response (PR) or complete response (CR), as assessed by the investigator using RECIST v1.1. | Up to approximately 1 year |
| Part 1: Duration of Response (DOR) |
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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 | 877-828-5568 | 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 | |
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
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Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor.
|
| CDK4 Inhibitor | Drug | Administered orally. |
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| Estrogen Receptor Antagonist | Drug | Administered by intramuscular injection. |
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| Aromatase Inhibitor | Drug | Administered orally. |
|
DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first.
| Up to approximately 1 year |
| Part 1: Time to Response (TTR) | TTR is defined as the time from treatment initiation to the first determination of objective response. | Up to approximately 1 year |
| Part 2: DOR | DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first. | Up to approximately 2 years |
| Part 2: TTR | TTR is defined as the time from treatment initiation to the first determination of objective response. | Up to approximately 2 years |
| Part 2: Disease Control Rate (DCR) | DCR is defined as the percentage of participants who achieve CR, PR, or stable disease as assessed by investigator's review. | Up to approximately 2 years |
| Part 2: Clinical Benefit Rate (CBR) | CBR is defined as the percentage of participants who achieve CR, PR, or durable stable disease (stable disease ≥ 24 weeks). | Up to approximately 2 years |
| Part 2: Progression-Free Survival (PFS) | PFS is defined as the time from the date of the first dose of study treatment(s) to the date of the first documentation of disease progression assessed by investigator's review or death, whichever occurs first. | Up to approximately 2 years |
| Part 2: 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, and laboratory values. | Up to approximately 2 years |
| Part 2: Recommended Phase 2 Dose (RP2D) | The RP2D of BG-75202 will take into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity. | Up to approximately 2 years |
| Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of BG-75202 | Up to approximately 4 months |
| Parts 1 and 2: Minimum Observed Plasma Concentration (Ctrough) of BG-75202 | Up to approximately 4 months |
| Parts 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202 | Up to approximately 4 months |
| Parts 1 and 2: Terminal Half-Life (t1/2) of BG-75202 | Up to approximately 4 months |
| Yale Cancer Center |
| Recruiting |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Washington University in St Louis | Recruiting | St Louis | Missouri | 63110-1010 | United States |
| Next Oncology Austin | Recruiting | Austin | Texas | 78758 | United States |
| The University of Texas Md Anderson Cancer Center | Recruiting | Houston | Texas | 77030-4009 | United States |
| Fred Hutchinson Cancer Research Center | Recruiting | Seattle | Washington | 98109-4433 | United States |
| Blacktown Cancer and Haematology Centre | Recruiting | Blacktown | New South Wales | NSW 2148 | Australia |
| Chris Obrien Lifehouse | Recruiting | Camperdown | New South Wales | NSW 2050 | Australia |
| Cancer Research South Australia | Recruiting | Adelaide | South Australia | SA 5000 | Australia |
| Austin Health | Recruiting | Heidelberg | Victoria | VIC 3084 | Australia |
| Peter Maccallum Cancer Centre | Recruiting | Melbourne | Victoria | VIC 3000 | Australia |
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| Sun Yat Sen University Cancer Center Huangpu Branch | Recruiting | Guangzhou | Guangdong | 510555 | China |
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150000 | China |
| Jiangsu Province Hospital Longjiang Branch | Recruiting | Nanjing | Jiangsu | 210036 | China |
| Fudan University Shanghai Cancer Centerpudong | Recruiting | Shanghai | Shanghai Municipality | 201321 | China |
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| Istituto Europeo Di Oncologia | Recruiting | Milan | 20141 | Italy |
| Istituto Nazionale Tumori Fondazione G Pascale | Recruiting | Naples | 80131 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Recruiting | Roma | 00168 | Italy |
| Istituto Clinico Humanitas | Recruiting | Rozzano | 20089 | Italy |
| Hospital Universitario Vall Dhebron | Recruiting | Barcelona | 08035 | Spain |
| Next Oncology Barcelona | Recruiting | Barcelona | 8023 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Clinico San Carlos | Recruiting | Madrid | 28240 | Spain |
| Hospital Universitario Virgen de La Victoria | Recruiting | Málaga | 29010 | Spain |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019941 | Cyclin-Dependent Kinase Inhibitor p16 |
| D065171 | Estrogen Receptor Antagonists |
| D047072 | Aromatase Inhibitors |
| ID | Term |
|---|---|
| D050756 | Cyclin-Dependent Kinase Inhibitor Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018797 | Cell Cycle Proteins |
| D011506 | Proteins |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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