First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors

Exclusion Criteria

• •Untreated brain or meningeal metastases (participants with history of metastases are eligible provide they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 28 days after definitive therapy).
• •Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
• •History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
• •Recent history (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, pericarditis, or clinically significant pericardial effusion, cardiac arrythmia or peripheral artery disease.
• •Recent history (within 6 months) of Childs-Pugh B or C classification of liver disease.
• •History of clinically significant medical and/or psychiatric conditions or any other reason that, in the opinion of the investigator, would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug.
• •History of uncontrolled, clinically significant endocrinopathy.
• •Known gastrointestinal disorders making absorption of oral medications problematic. Inability to swallow capsules.
• •If treated with anti-programmed cell death protein-1 (aPD-1)/antiprogrammed cell death protein-ligand 1(aPD-L1) targeting or other immunostimulatory agents in the past: excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity, hypersensitivity to administered drug or drug related toxicity requiring discontinuation.
• •Active autoimmune disease requiring systemic treatment in past 2-years (exceptions for endocrinopathies, vitiligo or atopic conditions)
• •History of solid organ transplant or allogeneic stem cell transplant.
• •History of interstitial lung disease or pneumonitis.
• •Major surgery ≤ 28 days prior to first dose of study drug.
• •Poorly controlled hypertension
• •History of hemorrhage, including hemoptysis, hematemesis, or melena
• •History of other malignancy, with the following exceptions:
• •* No known active disease present for within 3 years before first dose of study treatment and felt to be at low recurrence by investigator
• •* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• •* Adequately treated carcinoma in situ without evidence of disease
• •Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.