BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

Launched by BEIGENE · Nov 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BGB-43395, which targets a specific protein involved in cell growth, to see how well it works on its own or in combination with other treatments for patients with advanced breast cancer and other serious tumors. The main goal is to find the best dose of this medication. The trial focuses on patients with hormone receptor-positive (HR+) and HER2-negative breast cancer, as well as other advanced solid tumors, to help determine if this treatment can be beneficial for them.

To participate in this trial, individuals should have advanced cancer that has not responded to standard treatments, such as hormone therapy or chemotherapy. Specifically, women with HR+/HER2- breast cancer must be postmenopausal or receiving treatment to suppress their ovarian function. Participants can expect to be closely monitored during the study, and they may receive BGB-43395 alone or in combination with other medications. It's important to note that participants should not have received certain prior treatments that specifically target the same protein, and they should not have other serious health issues that could interfere with the study. This research aims to provide new options for patients who may have limited choices left in their cancer treatment journey.

Gender

ALL

Eligibility 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. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced/metastatic disease including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting.
• • 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:
• • 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.
• • Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at screening.
• • Participants with active hepatitis C infection.
• • Prior allogeneic stem cell transplantation, or organ transplantation.
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.