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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
XNW28012 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.
Karmanos Cancer Institute
Detroit, Michigan, United States
START - Midwest
Grand Rapids, Michigan, United States
START - New York Long Island
Lake Success, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Incidence of Adverse Events (AEs)
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs), including assessment of severity according to CTCAE criteria.
Time frame: From the first dose of study treatment through 30 days after the last dose of study treatment.
Incidence of Serious Adverse Events (SAEs)
Number and percentage of participants experiencing treatment-emergent serious adverse events (SAEs).
Time frame: From the first dose of study treatment through 30 days after the last dose of study treatment.
RP2D
To determine the optimal dose of XNW28012 for future development
Time frame: From the first dose of study treatment through 30 days after the last dose of study treatment.
Maximum Plasma Concentration (Cmax)
Maximum observed plasma concentration of study drug following administration.
Time frame: From first dose of study treatment through 30 days after the last dose of study treatment.
Area Under the Plasma Concentration-Time Curve (AUC)
Area under the plasma concentration-time curve of study drug following administration.
Time frame: From the first dose of study treatment through 30 days after the last dose of study treatment.
Terminal Elimination Half-Life (t1/2)
Terminal elimination half-life of study drug following administration.
Time frame: From first dose of study treatment through 30 days after the last dose of study treatment.
Time to Maximum Plasma Concentration (Tmax)
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Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
SCRI at Mary Crowley
Dallas, Texas, United States
START - San Antonio
San Antonio, Texas, United States
Time to reach maximum observed plasma concentration of study drug following administration.
Time frame: From first dose of study treatment through 30 days after the last dose of study treatment.
Incidence of Treatment-Emergent Anti-Drug Antibodies (ADA)
Proportion of participants who develop treatment-emergent anti-drug antibodies during the study period.
Time frame: From the first dose of study treatment through 30 days after the last dose of study treatment.
Objective Response Rate (ORR)
Percentage of participants with a best overall response of complete response (CR) or partial response (PR) as assessed by investigator according to \[RECIST 1.1/Lugano criteria\].
Time frame: 24 months
Duration of Response (DOR)
Time from the first documented objective response (CR or PR) to disease progression or death, assessed according to \[criteria\].
Time frame: 24 months
Progression-Free Survival (PFS)
Time from first dose of study treatment to documented disease progression or death from any cause.
Time frame: 24 months