Sacituzumab Tirumotecan for Pancreatic Cancer

Prior treatment

• Prior treatment with TROP2-targeted agents or antibody-drug conjugates (ADCs)
• Requirement for strong CYP3A4 inhibitors or inducers within 2 weeks prior to the first dose, or inability to avoid their use during the study
• Major surgery within 28 days prior to the first dose (excluding palliative procedures), or receipt of curative radiotherapy within 3 months
• Presence of other malignancies within 3 years prior to the first treatment (except for certain definitively treated cancers)
• Presence of severe underlying pulmonary disease, autoimmune disease, or prior total pneumonectomy
• Toxicities from prior antitumor therapy not recovered to ≤ Grade 1 (except for low-risk toxicities)
• Known allergy to the investigational drug or its components, or history of severe hypersensitivity to other biologic agents
• Severe infection within 4 weeks prior to dosing, or active infection requiring systemic therapy within 2 weeks
• Receipt of non-specific immunomodulatory therapy or antitumor traditional Chinese medicine within 2 weeks prior to dosing
• Receipt of live vaccines within 30 days prior to dosing or planned during the study period

Other illness

• History of or current presence of central nervous system metastases
• High risk of gastrointestinal or intra-abdominal bleeding
• History of severe dry eye syndrome, meibomian gland disease, or other corneal disorders that may impair corneal healing
• Uncontrolled severe systemic diseases such as cardiovascular or cerebrovascular disease, diabetes mellitus, or hypertension
• History of interstitial lung disease or non-infectious pneumonitis, or current related lesions
• Active chronic inflammatory bowel disease, gastrointestinal obstruction, or other severe gastrointestinal disorders
• Tumor invasion of critical organs or vessels with associated symptoms, or risk of fistula formation
• Active hepatitis B, hepatitis C, HIV infection, or active syphilis
• Individuals considered vulnerable populations (e.g., patients with psychiatric disorders or critically ill patients), or any other condition deemed unsuitable for enrollment by the investigator.

Other

• Presence of untreated or unstable spinal cord compression
• Pregnant or breastfeeding women, or individuals of childbearing potential who are not using highly effective contraception as required

• Voluntary participation with written informed consent provided
• Age ≥18 years at the time of signing the informed consent form
• Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma)
• Failure of or disease progression after at least one prior line of systemic therapy for locally advanced or metastatic pancreatic cancer
• At least one measurable target lesion at baseline per RECIST 1.1 criteria (a single measurable lesion must not have received prior radiotherapy, or must have demonstrated clear progression after radiotherapy)
• ECOG performance status score of 0-2
• Adequate organ and bone marrow function (including hematologic, hepatic, renal, and coagulation parameters meeting specified criteria)
• Subjects of childbearing potential must use highly effective contraception, and female subjects must have a negative pregnancy test
• Ability and willingness to comply with study-related procedures.