An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors
Recruiting · NCT07222267 · Interventional (participants receive a specific treatment) · Lead sponsor: BeOne Medicines
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
31 locations listed across 5 US states.
- University of Alabama At Birmingham Hospital - Birmingham, Alabama, United States
- Yale Cancer Center - New Haven, Connecticut, United States
- Washington University in St Louis - St Louis, Missouri, United States
- Next Oncology Austin - Austin, Texas, United States
- The University of Texas Md Anderson Cancer Center - Houston, Texas, United States
- Fred Hutchinson Cancer Research Center - Seattle, Washington, United States
- Hospital Universitario Vall Dhebron - Barcelona, Spain
- Next Oncology Barcelona - Barcelona, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Hospital Clinico San Carlos - Madrid, Spain
- Istituto Europeo Di Oncologia - Milan, Italy
- Hospital Universitario Virgen de La Victoria - Málaga, Spain
- Istituto Nazionale Tumori Fondazione G Pascale - Naples, Italy
- Fondazione Policlinico Universitario Agostino Gemelli - Roma, Italy
- Istituto Clinico Humanitas - Rozzano, Italy
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing, Beijing Municipality, China
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China
- Chongqing University Cancer Hospital - Chongqing, Chongqing Municipality, China
- The First Affiliated Hospital of Xiamen University - Xiamen, Fujian, China
- Auckland City Hospital - Auckland, Grafton, New Zealand
- Sun Yat Sen University Cancer Center Huangpu Branch - Guangzhou, Guangdong, China
- Harbin Medical University Cancer Hospital - Harbin, Heilongjiang, China
- Jiangsu Province Hospital Longjiang Branch - Nanjing, Jiangsu, China
- Blacktown Cancer and Haematology Centre - Blacktown, New South Wales, Australia
- Chris Obrien Lifehouse - Camperdown, New South Wales, Australia
- Fudan University Shanghai Cancer Centerpudong - Shanghai, Shanghai Municipality, China
- Cancer Research South Australia - Adelaide, South Australia, Australia
- Tianjin Medical University Cancer Institute and Hospital - Tianjin, Tianjin Municipality, China
- Austin Health - Heidelberg, Victoria, Australia
- Peter Maccallum Cancer Centre - Melbourne, Victoria, Australia
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China