This study was a randomized, double-blind, multicenter phase III clinical study.
A total of 226 patients with metastatic pancreatic ductal carcinoma who had failed or were intolerant to two previous standard therapies were planned.Subjects will be randomized in a 2:1 ratio to either the experimental group or the control group:Experimental Group: XNW28012 for Injection (2.4 mg/kg, administered once every 3 weeks);Control group: XNW28012 mimetic for Injection (administered once every 3 weeks).Both experimental and control subjects will receive optimal supportive care, including but not limited to nutritional support, adjustment of electrolyte balance, and cancer pain support treatment.
Metastatic pancreatic ductal adenocarcinoma (PDAC), including adenosquamous carcinoma, confirmed histologically or cytologically.
Disease progression or toxicity intolerance after receiving two previous standard therapies (gemcitabine and fluorouracil-based chemotherapy).
Men and women were 18 years of age or older at the time of informed consent. At least one measurable lesion met RECIST 1.1 criteria. The region should have received no previous local treatment, such as radiotherapy, or there should be evidence of definite progression after the completion of local treatment, such as radiotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Patients with prior severe infusion reactions to macromolecular drugs such as antibody-drug conjugates (ADCs) or monoclonal antibodies, or allergic reactions to any component of XNW28012; patients with prior exposure to ADCs with a topoisomerase I inhibitor payload or TF-targeted anti-tumor agents.
Inadequate washout period from previous antineoplastic therapy before the first study drug, defined as follows:Chemotherapy or small molecule targeted therapy <2 weeks or 5 half-lives, whichever is shorter;Macromolecule monoclonal antibody treatment <3 weeks;Hormone therapy <3 weeks;Anti-tumor Chinese patent Medicine (with clear indications in the package insert) <2 weeks;Brain radiotherapy <2 weeks, palliative radiotherapy <2 weeks, and radical radiotherapy <4 weeks.
Any active malignancy, with the exception of the specific cancers studied in this trial and any cured localized neoplasm, e.g., eradicated noninvasive basal cell or squamous cell carcinoma, noninvasive superficial bladder cancer, carcinoma in situ of the cervix or breast, etc.
Receive live vaccine within 4 weeks before randomization. Note: Seasonal influenza vaccine is generally inactivated vaccine and can be used. However, intranasal influenza vaccines are not permitted if they are live attenuated.
Parallel
XNW28012 for injection
DrugXNW28012 for Injection (2.4 mg/kg, administered once every 3 weeks)
XNW28012 Mimetic for Injection
DrugXNW28012 Mimetic for Injection (administered once every 3 weeks)
The time from the date of subject enrollment to the date of death from any cause
Progression free survival (PFS)
Progression free survival (PFS) per RECIST1.1 assessed by Investigator
Objective response rate (ORR)
ORR is defined as the proportion of subjects who have a confirmed CR or a PR per RECIST 1.1 assessed by Investigator.
Disease control rate (DCR)
Rate of complete response \[CR\], partial response \[PR\], and stable disease per RECIST1.1 assessed by Investigator.
Duration of response (DOR)
Duration of response (DOR) per RECIST1.1 assessed by Investigator.
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