A Phase I, Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of XNW28012 Monotherapy in the Treatment of Subjects with Metastatic Pancreatic Cancer
subjects with histologically or cytologically confirmed metastatic PDAC, whose disease has progressed after at least 1 prior systemic therapy.
Age ≥ 18 years old at the time of consent.
Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. ECOG status of 2 can be allowed if it is a result of disease progression and warrantsdiscussion with the medical monitor.
Subjects must have adequate organ function within 7 days prior to the first study drug administration, as indicated by the following laboratory values;
A history of severe infusion reactions to other monoclonal antibodies/antibody drug conjugates (ADCs), or allergic reactions to any components of XNW28012, or treatment with TF-directed therapy.
Any anti-tumor therapy within 21 days prior to the first dose, including but not limited to: small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or any other experimental drugs.
Any active malignancy, with the exception of the specific types of cancersunder investigation in this study and any locally recurring cancer that has been treated curatively .
Have received a live vaccine within 4 weeks prior to the first dose of study drug. Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed; however, intranasal influenza vaccines will not be allowed if they are attenuated live vaccines.
Parallel
XNW28012
DrugXNW28012 is an antibody-drug conjugate (ADC) composed of a humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) targeting Tissue Factor (TF) and a topoisomerase I inhibitor.
Incidence of Adverse Events (AEs)
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs), including assessment of severity according to CTCAE criteria.
Incidence of Serious Adverse Events (SAEs)
Number and percentage of participants experiencing treatment-emergent serious adverse events (SAEs).
RP2D
To determine the optimal dose of XNW28012 for future development
Maximum Plasma Concentration (Cmax)
Maximum observed plasma concentration of study drug following administration.
Area Under the Plasma Concentration-Time Curve (AUC)
Area under the plasma concentration-time curve of study drug following administration.
Terminal Elimination Half-Life (t1/2)
Terminal elimination half-life of study drug following administration.
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