A Study in Subjects With Advanced Solid Tumors

Exclusion Criteria

• •1. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 3 weeks of the first dose of current study drug.
• •2. Any relevant bispecific antibody, and/or anti-PD-1/PDL1 agents. For selected indication cohorts, prior treatment may be permitted after discussion with the Sponsor. Prior therapy with PD-1/PDL1 inhibitor may be allowed in agreement with the Sponsor.
• •3. Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug; a 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease with Sponsor approval.
• •4. Persisting toxicity with Grade \>1 severity related to prior therapy based on NCI-CTCAE Version 5.0.
• •Note: Sensory neuropathy and alopecia of Grade ≤2 are acceptable.
• •5. Expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).
• •6. Known severe hypersensitivity reactions (NCI-CTCAE Grade ≥3) to fully human monoclonal antibodies, or severe reaction to immuno-oncology agents, such as colitis or pneumonitis, requiring treatment with steroids, or has a history of interstitial lung disease (ILD), any history of anaphylaxis, or uncontrolled asthma.
• •7. Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication.
• •Note: Corticosteroid use as a premedication for IV contrast allergies/reactions is allowed. Subjects who are receiving daily corticosteroid replacement therapy are an exception to this rule. Daily prednisone at doses of up to 7.5 mg or equivalent hydrocortisone doses are examples of permitted replacement therapy. Use of inhaled or topical corticosteroids is permitted.
• •8. CNS tumor, metastasis, and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period or identified prior to consent.
• •Note: Subjects with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (defined as 2 brain images, both of which are obtained after treatment to the brain metastases; these imaging scans should both be obtained ≥4 weeks apart). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have returned to baseline or resolved. Any steroids administered as part of this therapy must be completed ≥3 days prior to the first dose of study medication.
• •9. Active or history of autoimmune disease that has required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
• •Note: Subjects with diabetes type 1, vitiligo, psoriasis, and hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
• •10. Allogeneic tissue/solid organ transplant, except those not requiring immuno-suppressive treatment.
• •11. Active infection requiring treatment.
• •12. History of human immunodeficiency virus (HIV) type 1 or 2 antibodies.
• •13. Known active hepatitis B whose virus load is greater than 500 IU/mL.
• •14. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥II), or serious uncontrolled cardiac arrhythmia requiring medication.
• •15. History or current evidence of any condition, therapy, active infections, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• •16. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• •17. Legally incapacitated or has limited legal capacity.
• •18. Pregnant or breastfeeding.