Estrogen Receptor Antagonist: Administered by intramuscular injection.
Aromatase Inhibitor: Administered orally.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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 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.
Part 1: Recommended Dose for Expansion (RDFE) — Estimated approximately 1 year 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.
Part 2: Overall Response Rate (ORR) — Up to approximately 2 years 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).
Trial sites (31)
Facility
City
Region
Status
University of Alabama At Birmingham Hospital
Birmingham
Alabama
Recruiting
Yale Cancer Center
New Haven
Connecticut
Recruiting
Washington University in St Louis
St Louis
Missouri
Recruiting
Next Oncology Austin
Austin
Texas
Recruiting
The University of Texas Md Anderson Cancer Center
Houston
Texas
Recruiting
Fred Hutchinson Cancer Research Center
Seattle
Washington
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown
New South Wales
Recruiting
Chris Obrien Lifehouse
Camperdown
New South Wales
Recruiting
Cancer Research South Australia
Adelaide
South Australia
Recruiting
Austin Health
Heidelberg
Victoria
Recruiting
Peter Maccallum Cancer Centre
Melbourne
Victoria
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
Recruiting
Sun Yat Sen University Cancer Center Huangpu Branch
Guangzhou
Guangdong
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
Jiangsu Province Hospital Longjiang Branch
Nanjing
Jiangsu
Recruiting
Fudan University Shanghai Cancer Centerpudong
Shanghai
Shanghai Municipality
Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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