SL-28 for Advanced Solid Tumours

Inclusion Criteria

• •Ability to provide written informed consent prior to any study-related procedures and to understand the nature, purpose, and potential risks of the study
• •Adult males and females ≥18 years of age at screening
• •Life expectancy of at least 3 months
• •Histologically or cytologically confirmed unresectable advanced solid tumor (recurrent, metastatic, or locally advanced)
• •Disease refractory to, intolerant of, or refusal of standard therapies, including immunotherapy and molecular/biomarker-directed treatments, as determined by the Principal Investigator (PI) or delegate
• •Eligible tumor types include:
• •Head and neck squamous cell carcinoma
• •Thoracic malignancies (small-cell lung cancer, non-small cell lung cancer, esophageal cancer)
• •Gastrointestinal malignancies (gastric, liver, colorectal, pancreatic adenocarcinoma)
• •Genitourinary malignancies (bladder, renal cell, prostate cancer)
• •Gynecologic malignancies (ovarian, endometrial cancer)
• •Breast cancer and melanoma
• •Evaluable disease per RECIST v1.1
• •ECOG performance status 0-1 (or up to 2 at PI discretion)
• •Adequate organ function, defined as:
• •Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for liver metastases or Gilbert's syndrome)
• •AST, ALT, alkaline phosphatase ≤2.5 × ULN (≤5 × ULN if liver metastases, at PI discretion)
• •Creatinine clearance ≥50 mL/min (Cockcroft-Gault) or eGFR ≥50 mL/min (CKD-EPI)
• •Absolute neutrophil count ≥1,000/mm³
• •Platelet count ≥100,000/mm³
• •Hemoglobin ≥90 g/L without transfusion within 2 weeks
• •Prothrombin time and aPTT ≤1.5 × ULN (or stable INR if on anticoagulation)
• •Female patients:
• •Non-childbearing potential (surgically sterile or postmenopausal), or of childbearing potential with negative pregnancy tests and agreement to effective contraception through 90 days post-dose
• •Male patients:
• •Agreement not to donate sperm for 90 days post-dose
• •Agreement to use adequate contraception as applicable
• •Suitable venous access for blood sampling
• •Willingness and ability to comply with study procedures and protocol requirements