Comparing STAR0602 with Irinotecan (Camptosar) for advanced solid tumors

Exclusion

• −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.
• −Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
• −Participants with a history of known autoimmune disease with exceptions of:
• −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;
• −Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.
• −Adrenal insufficiency well controlled on replacement therapy.
• −Prior therapy within the following timeframe before planned infusion of STAR0602 as follows:
• −Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies within 6 weeks prior to the initiation of study drug or participants who have not recovered (i.e., ≤ Grade 1 or to baselineBaselineYour starting measurements, taken before treatment begins.Read more →) from AEs due to agents administered more than 4 weeks earlier. Note: Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.
• −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.
• −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.
• −Bulky disease defined as any lesion ≥ 5 cm in greatest dimension unless approved by the SponsorSponsorThe organisation responsible for the study overall.Read more →.
• −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).
• −Major surgery or traumatic injury within 8 weeks before first dose of study drug.
• −Unhealed wounds from surgery or injury.
• −Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventionalInterventional studyA study where participants are given something to see what happens.Read more → radiology procedure, or similar investigational therapies within ≤ 2 weeks or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to a previously administered agent;
• −Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.