Recruiting NCT07222267
An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BG-75202, CDK4 Inhibitor, Estrogen Receptor Antagonist, Aromatase Inhibitor.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Advanced Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, China, Italy, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug BG-75202
Administered orally. - Drug CDK4 Inhibitor
Administered orally. - Drug Estrogen Receptor Antagonist
Administered by intramuscular injection. - Drug Aromatase Inhibitor
Administered orally.
Primary outcome measures
- Part 1: Number of Participants with Adverse Events (AEs) [Time frame: 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) [Time frame: Estimated approximately 1 year]
- Part 2: Overall Response Rate (ORR) [Time frame: Up to approximately 2 years]
Secondary outcome measures (12)
- Part 1: ORR [Time frame: Up to approximately 1 year]
- Part 1: Duration of Response (DOR) [Time frame: Up to approximately 1 year]
- Part 1: Time to Response (TTR) [Time frame: Up to approximately 1 year]
- Part 2: DOR [Time frame: Up to approximately 2 years]
- Part 2: TTR [Time frame: Up to approximately 2 years]
- Part 2: Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
- Part 2: Clinical Benefit Rate (CBR) [Time frame: Up to approximately 2 years]
- Part 2: Progression-Free Survival (PFS) [Time frame: Up to approximately 2 years]
- Part 2: Number of Participants with Adverse Events (AEs) [Time frame: Up to approximately 2 years]
- Part 2: Recommended Phase 2 Dose (RP2D) [Time frame: Up to approximately 2 years]
- Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of BG-75202 [Time frame: Up to approximately 4 months]
- Parts 1 and 2: Minimum Observed Plasma Concentration (Ctrough) of BG-75202 [Time frame: Up to approximately 4 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 10 centers
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- Beijing Cancer Hospital — Beijing
- Chongqing University Cancer Hospital — Chongqing
- The First Affiliated Hospital of Xiamen University — Xiamen
- Sun Yat Sen University Cancer Center Huangpu Branch — Guangzhou
- Harbin Medical University Cancer Hospital — Harbin
- Jiangsu Province Hospital Longjiang Branch — Nanjing
- Fudan University Shanghai Cancer Centerpudong — Shanghai
- … and 2 more centers
United States · 6 centers
- University of Alabama At Birmingham Hospital — Birmingham
- Yale Cancer Center — New Haven
- Washington University in St Louis — St Louis
- Next Oncology Austin — Austin
- The University of Texas Md Anderson Cancer Center — Houston
- Fred Hutchinson Cancer Research Center — Seattle
Australia · 5 centers
- Blacktown Cancer and Haematology Centre — Blacktown
- Chris Obrien Lifehouse — Camperdown
- Cancer Research South Australia — Adelaide
- Austin Health — Heidelberg
- Peter Maccallum Cancer Centre — Melbourne
Spain · 5 centers
- Hospital Universitario Vall Dhebron — Barcelona
- Next Oncology Barcelona — Barcelona
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Clinico San Carlos — Madrid
- Hospital Universitario Virgen de La Victoria — Málaga
Italy · 4 centers
- Istituto Europeo Di Oncologia — Milan
- Istituto Nazionale Tumori Fondazione G Pascale — Naples
- Fondazione Policlinico Universitario Agostino Gemelli — Roma
- Istituto Clinico Humanitas — Rozzano
Identifiers
NCT: NCT07222267 · BG-75202-101 · 2025-523553-34-00