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An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors

NCT07222267 · BeOne Medicines
In plain English

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Official title
A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors
About this study
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.
Eligibility criteria
Inclusion Criteria: * Part 1A: Participants with histologically or cytologically confirmed advanced, metastatic breast cancer and other solid tumors who have exhausted, are intolerant of all available standard of care therapies, and/or without available standard of care therapies. * Part 1B and Part 2A: Participants with advanced breast cancer with 1 to 3 prior lines of systemic therapy in the metastatic setting. Prior lines in the advanced/ metastatic setting may not exceed 2 lines of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload). * Parts 2B and 2C: Participants with advanced breast cancer enrolled in regions where cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are not approved and/or not available as the first-line treatment and who are CDK4/6 inhibitor treatment naïve and did not receive any previous systemic treatment for advanced disease. * Participants with breast cancer must have histologically or cytologically confirmed advanced breast cancer at the time of most recent testing, based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. * Female participants with metastatic breast cancer must be postmenopausal or receiving ovarian function suppression treatment. * Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate organ function. Exclusion Criteria: * Prior exposure to KAT6A/B or KAT7 inhibitors/degraders. * Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis. * Participants with any malignancy ≤ 3 years before screening for the study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively which in the opinion of the investigator is unlikely to require intervention during the study. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study design
Enrollment target: 86 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-11
Estimated completion: 2037-01-13
Last updated: 2026-04-15
Interventions
Drug: BG-75202Drug: CDK4 InhibitorDrug: Estrogen Receptor AntagonistDrug: Aromatase Inhibitor
Primary outcomes
  • Part 1: Number of Participants with Adverse Events (AEs) (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) (Estimated approximately 1 year)
  • Part 2: Overall Response Rate (ORR) (Up to approximately 2 years)
Sponsor
BeOne Medicines · industry
Contacts & investigators
ContactStudy Director · contact · clinicaltrials@beonemed.com · 877-828-5568
InvestigatorStudy Director · study_director, BeOne Medicines
All locations (20)
University of Alabama At Birmingham HospitalRecruiting
Birmingham, Alabama, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Washington University in St LouisRecruiting
St Louis, Missouri, United States
Next Oncology AustinRecruiting
Austin, Texas, United States
The University of Texas Md Anderson Cancer CenterRecruiting
Houston, Texas, United States
Blacktown Cancer and Haematology CentreRecruiting
Blacktown, New South Wales, Australia
Cancer Research South AustraliaRecruiting
Adelaide, South Australia, Australia
Peter Maccallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Cancer Hospital Chinese Academy of Medical SciencesRecruiting
Beijing, Beijing Municipality, China
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
Sun Yat Sen University Cancer Centerhuangpu BranchRecruiting
Guangzhou, Guangdong, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, Heilongjiang, China
Jiangsu Province Hospital Longjiang BranchRecruiting
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer CenterpudongRecruiting
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and HospitalRecruiting
Tianjin, Tianjin Municipality, China
Fondazione Policlinico Universitario Agostino GemelliRecruiting
Roma, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Clinico San CarlosRecruiting
Madrid, Spain
Hospital Universitario Virgen de La VictoriaRecruiting
Málaga, Spain
An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors · TrialPath