A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

Exclusion Criteria18

• Participants with a history of known autoimmune disease with exceptions of:
• Vitiligo;
• Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;
• History of Graves' disease, now euthyroid for \> 4 weeks;
• Hypothyroidism managed by thyroid replacement;
• Alopecia;
• Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.
• Adrenal insufficiency well controlled on replacement therapy.
• Major surgery or traumatic injury within 8 weeks before first dose of study drug.
• Unhealed wounds from surgery or injury.
• Treatment with \>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.
• Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
• Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
• Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
• Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
• Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.
• Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).
• Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.