Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors

Exclusion Criteria

• •Untreated central nervous system metastases and/or leptomeningeal carcinomatosis
• •Known additional malignancy that is progressing and/or requires active treatment
• •Prior exposure to drugs that are agonists of IL-2- or IL-15-like but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar)
• •History of and current interstitial lung disease or fibrosis and pneumonitis; patients with clinically significant or oxygen requiring chronic obstructive pulmonary disease or any chronic inflammatory disease (sarcoidosis etc.)
• •Has received a live vaccine within 30 days of planned start of study therapy
• •Absolute white blood cell count ≤2.0 ×10e9/L
• •Absolute neutrophil count ≤1.0 ×10e9/L
• •Platelet count ≤100×10e9/L
• •Pregnant or breastfeeding women
• •Any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma, or history of syndrome that required systemic steroids (except the allowed doses) or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy
• •Specific co-morbidities
• •Parts B and B1:
• •* Is hypersensitive to any of the ingredients of pembrolizumab drug product (KEYTRUDA®)
• •* History of solid organ transplantation or hematopoietic stem cell transplantation