Advanced Solid Tumor, Breast Cancer
Conditions
Keywords
KAT6 inhibitor
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.
Interventions
DRUGBG-75202
Administered orally.
DRUGCDK4 Inhibitor
Administered orally.
DRUGEstrogen Receptor Antagonist
Administered by intramuscular injection.
DRUGAromatase Inhibitor
Administered orally.
Sponsors
BeOne Medicines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Australia, China, Italy, New Zealand, Spain, United States
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed