An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors
- Conditions
- Breast CancerAdvanced Solid Tumor
- Interventions
- Drug: BG-75202Drug: Estrogen Receptor AntagonistDrug: CDK4 InhibitorDrug: Aromatase Inhibitor
- Registration Number
- NCT07222267
- Lead Sponsor
- BeOne Medicines
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 86
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1A: Dose Escalation and Safety Expansion, BG-75202 Monotherapy BG-75202 Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy. Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist BG-75202 Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist. Part 1B: Dose Escalation and Safety Expansion, BG-75202 + Estrogen Receptor Antagonist Estrogen Receptor Antagonist Sequential cohorts of increasing dose levels of BG-75202 will be evaluated in combination with an estrogen receptor antagonist. Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist BG-75202 Participants will receive BG-75202 in combination with an estrogen receptor antagonist. Part 2A: Dose Optimization, BG-75202 + Estrogen Receptor Antagonist Estrogen Receptor Antagonist Participants will receive BG-75202 in combination with an estrogen receptor antagonist. Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor BG-75202 Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor. Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor CDK4 Inhibitor Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor. Part 2B: Safety Run-In, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor Aromatase Inhibitor Participants will receive BG-75202 in combination with a cyclin-dependent kinase 4 (CDK4) inhibitor and an aromatase inhibitor. Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor BG-75202 Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor. Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor CDK4 Inhibitor Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor. Part 2C: Dose Expansion, BG-75202 + CDK4 inhibitor + Aromatase Inhibitor Aromatase Inhibitor Participants will receive BG-75202 in combination with a CDK4 inhibitor and an aromatase inhibitor.
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Part 1: ORR Up to approximately 1 year ORR is defined as the percentage of participants with partial response (PR) or complete response (CR), as assessed by the investigator using RECIST v1.1.
Part 1: Duration of Response (DOR) Up to approximately 1 year DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first.
Part 1: Time to Response (TTR) Up to approximately 1 year TTR is defined as the time from treatment initiation to the first determination of objective response.
Part 2: DOR Up to approximately 2 years DOR is defined as the time from the first determination of an objective response to disease progression documented after treatment initiation or death, whichever occurs first.
Part 2: TTR Up to approximately 2 years TTR is defined as the time from treatment initiation to the first determination of objective response.
Part 2: Disease Control Rate (DCR) Up to approximately 2 years DCR is defined as the percentage of participants who achieve CR, PR, or stable disease as assessed by investigator's review.
Part 2: Clinical Benefit Rate (CBR) Up to approximately 2 years CBR is defined as the percentage of participants who achieve CR, PR, or durable stable disease (stable disease ≥ 24 weeks).
Part 2: Progression-Free Survival (PFS) Up to approximately 2 years PFS is defined as the time from the date of the first dose of study treatment(s) to the date of the first documentation of disease progression assessed by investigator's review or death, whichever occurs first.
Part 2: Number of Participants with Adverse Events (AEs) Up to approximately 2 years Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, and laboratory values.
Part 2: Recommended Phase 2 Dose (RP2D) Up to approximately 2 years The RP2D of BG-75202 will take into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity.
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of BG-75202 Up to approximately 4 months Parts 1 and 2: Minimum Observed Plasma Concentration (Ctrough) of BG-75202 Up to approximately 4 months Parts 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202 Up to approximately 4 months Parts 1 and 2: Terminal Half-Life (t1/2) of BG-75202 Up to approximately 4 months
Trial Locations
- Locations (1)
Next Oncology
🇺🇸Austin, Texas, United States
Next Oncology🇺🇸Austin, Texas, United States