None listed
Conditions
Interventions
-Drug: BGB-43395
Planned doses administered orally.
-Drug: Fulvestrant
Standard dose administered via intramuscular injection.
-Drug: Letrozole
Standard dose administered orally as a tablet.
Sponsors
jRCT Inquiry IQVIA Contact Point
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Phase 1a (Dose Escalation) and 1b (Dose Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. -Phase 1a: Received prior therapy for their condition (if available) and should be refractory to or intolerant of standard-of-care therapies. In regions where approved and available, participants with HR+ breast cancer must have received at least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor. -Phase 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additional tumor types. -Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received at least one line of therapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. -Stable Eastern Cooperative Oncology Group (ECOG) Performance Status <= 1. -Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment. -Adequate organ function without symptomatic visceral disease.
Exclusion criteria
Exclusion criteria: -Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is permitted and required in local regions where it is approved and available). -Known leptomeningeal disease or uncontrolled, untreated brain metastases. -Any malignancy <= 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). -Uncontrolled diabetes. -Infection requiring systemic antibacterial, antifungal, or antiviral therapy <= 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection. -History of hepatitis B or active hepatitis C infection. -Prior allogeneic stem cell transplantation, or organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to approximately 60 months] -Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria. -Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395 [Time Frame: Up to approximately 60 months] -MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 28%. MAD is defined as the highest dose administered if MTD is not reached. -Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395 [Time Frame: Up to approximately 60 months] -RDFE of BGB-43395 alone or in combination with fulvestrant or letrozole will be determined based upon the MTD or MAD. -Phase 1b: Objective Response Rate (ORR) [Time Frame: Up to approximately 60 months] -ORR is defined as the percentage of participants who have confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | — |
Countries
Australia, France, Japan, New Zealand, United States
Contacts
Public ContactShiori Maeda
IQVIA Services Japan G.K
Outcome results
None listed