An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors
NCT ID: NCT07222267
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
86 participants
INTERVENTIONAL
2025-12-11
2036-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
BG-75202
Administered orally.
Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist
Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist.
BG-75202
Administered orally.
Estrogen Receptor Antagonist
Administered by intramuscular injection.
Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist
Participants will receive BG-75202 in combination with an estrogen receptor antagonist.
BG-75202
Administered orally.
Estrogen Receptor Antagonist
Administered by intramuscular injection.
Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor
Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor.
BG-75202
Administered orally.
CDK4 Inhibitor
Administered orally.
Aromatase Inhibitor
Administered orally.
Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor
Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor.
BG-75202
Administered orally.
CDK4 Inhibitor
Administered orally.
Aromatase Inhibitor
Administered orally.
Interventions
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BG-75202
Administered orally.
CDK4 Inhibitor
Administered orally.
Estrogen Receptor Antagonist
Administered by intramuscular injection.
Aromatase Inhibitor
Administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Next Oncology Austin
Austin, Texas, United States
Cancer Research South Australia
Adelaide, South Australia, Australia
Countries
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Central Contacts
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Other Identifiers
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2025-523553-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
BG-75202-101
Identifier Type: -
Identifier Source: org_study_id