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

Inclusion Criteria:

• Phase 1a (Dose Escalation) and 1b (Dose Expansion): Participants with histologicallyor cytologically confirmed advanced, metastatic, or unresectable solid tumorsassociated 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 berefractory to, or intolerant of standard-of-care therapies. In regions whereapproved and available, participants with HR+ breast cancer must have received atleast 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor.For combination with elacestrant, participants must have received at least 1 priorline of treatment for advanced/metastatic disease including prior endocrine therapyand CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting.

• Phase 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additionaltumor types.

• Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6inhibitors are approved and available must have received at least one line oftherapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor.Participants can have received up to 2 lines of prior cytotoxic chemotherapy foradvanced disease.

• Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

• Female participants with metastatic HR+/HER2- breast cancer must be postmenopausalor receiving ovarian function suppression treatment.

• Adequate organ function without symptomatic visceral disease.

Exclusion Criteria:

• Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy ispermitted 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 thespecific cancer under investigation in this study and any locally recurring cancerthat has been treated with curative intent (eg, resected basal or squamous cell skincancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).

• Uncontrolled diabetes.

• Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28days 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.