Study of XNW28012 in Subjects With Metastatic Pancreatic Cancer Who Received Prior Systemic Therapy
A Randomized, Double-blind, Multicenter Phase III Clinical Study Comparing XNW28012 Versus Placebo in Combination With Best Supportive Care in Patients With Metastatic Pancreatic Cancer Who Have Received Prior Systemic Therapy
1 other identifier
interventional
226
1 country
48
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pancreatic-cancer
Started Jul 2025
Shorter than P25 for phase_3 pancreatic-cancer
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2025
CompletedFirst Submitted
Initial submission to the registry
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
September 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
September 16, 2026
September 1, 2026
1.9 years
July 21, 2026
September 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The time from the date of subject enrollment to the date of death from any cause
through study completion, an average of 2 year
Secondary Outcomes (11)
Progression free survival (PFS)
through study completion, an average of 2 year
Objective response rate (ORR)
through study completion, an average of 2 year
Disease control rate (DCR)
through study completion, an average of 2 year
Duration of response (DOR)
through study completion, an average of 2 year
Time to Response (TTR)
through study completion, an average of 2 year
- +6 more secondary outcomes
Study Arms (2)
XNW28012 for injection
ACTIVE COMPARATORXNW28012 for injection (2.4 mg/kg, administered once every 3 weeks)
XNW28012 mimetic for injection
PLACEBO COMPARATORXNW28012 Mimetic for Injection (administered once every 3 weeks)
Interventions
XNW28012 for Injection (2.4 mg/kg, administered once every 3 weeks)
XNW28012 Mimetic for Injection (administered once every 3 weeks)
Eligibility Criteria
You may qualify if:
- 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.
- Subjects had to have adequate levels of organ function within 7 days before randomization.
- Female subjects of childbearing potential had to undergo a urine pregnancy or serum pregnancy test with a negative result within 7 days before randomization. If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test must be performed.
- Use of a medically approved, highly effective contraceptive method during the study and for 6 months after the last administration of study medication; Male subjects whose partner is a female of reproductive age should be surgically sterilized or agree to use an effective method of contraception during the study and for 6 months after the last study dose. In addition, male participants had to agree not to donate sperm during the study and for 6 months after the last study dose.
- I have signed the informed consent form and am willing and able to follow the study procedures required by the protocol.
You may not qualify if:
- 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.
- Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte/macrophage colony-stimulating factor within 1 week before randomization or pegylated G-CSF within 2 weeks before randomization. He had received a blood transfusion within 2 weeks before randomization. Erythropoietin (EPO) or IL-11 was administered within 1 week before randomization.
- Hypoalbuminemia that was difficult to correct within 7 days before randomization.
- Within 3 days before randomization, an ECOG score increase of ≥1 point from the ICF signing score or a weight loss of ≥10%.
- Subjects who have not recovered to CTCAE grade ≤1 or stable toxicity from prior anticancer therapy, except for adverse events that are not considered to be a possible safety risk (e.g., alopecia or pigmentation).
- Previous history of cerebral arteriovenous malformation, cerebral aneurysm, or stroke (including transient ischemic attack within 1 month before screening, except old or asymptomatic cerebral infarction).
- Presence of any of the following hematologic risk factors:Known coagulation defects resulting in an increased risk of bleeding;Diffuse alveolar hemorrhage due to vasculitis;Known bleeding-prone constitution;Persistent heavy bleeding;Trauma that increases the risk of life-threatening bleeding;History of severe cranial trauma or intracranial surgery within 8 weeks prior to the start of the trial.
- Subjects who are unwilling or unable to provide tumor tissue samples that meet the requirements for tissue factor (TF) expression detection.
- Presence of clinically significant cardiovascular/cerebrovascular disease:History of unstable angina pectoris;Myocardial infarction within 6 months before screening;Angioplasty or cardiac stenting within 6 months before screening;History of New York Heart Association (NYHA) class 3-4 congestive heart failure;Abnormal QTc interval at baseline (QTcF \> 480 ms);Occurrence of grade ≥ 2 ventricular arrhythmias and/or grade III atrioventricular block requiring clinical management within 6 months prior to screening;Poorly controlled hypertension: systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg while using standard antihypertensive therapy;Presence of cardiac disease/history resulting in a left ventricular ejection fraction (LVEF) \< 50%.
- Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Subjects with previous cicatricial conjunctivitis and active eye diseases during the screening period; Subjects with glaucoma of CTCAE grade ≥2.
- A history of toxic epidermal necrolysis (TEN) or Steven Johnson syndrome.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Tsinghua Changgung Hospital
Beijing, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
Affiliated Hospital of Binzhou Medical College
Binzhou, China
Hunan Cancer Hospital
Changsha, China
The First People's Hospital of Changzhou
Changzhou, China
Sichuan Provincial People's Hospital
Chengdu, China
West China Hospital, Sichuan University
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
Fuyang Cancer Hospital
Fuyang, China
Fujian Cancer Hospital
Fuzhou, China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Ha’erbin, China
Anhui Provincial Cancer Hospital
Hefei, China
The First Hospital of Jilin University
Jilin City, China
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, China
Jinan Central Hospital
Jinan, China
Gansu Provincial Cancer Hospital
Lanzhou, China
Meizhou People's Hospital
Meizhou, China
Jiangxi Provincial Cancer Hospital
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Cancer Hospital
Nanjing, China
Jiangsu Provincial People's Hospital
Nanjing, China
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing, China
Tumor Hospital Affiliated to Guangxi Medical University
Nanning, China
Peking University Cancer Hospital Inner Mongolia Hospital
Neimeng, China
People's Hospital Affiliated to Ningbo University
Ningbo, China
Shanghai East Hospital
Shanghai, China
Shanghai Fourth People's Hospital
Shanghai, China
Zhongshan Hospital, Fudan University
Shanghai, China
Liaoning Cancer Hospital
Shenyang, China
The First Affiliated Hospital of China Medical University
Shenyang, China
Shanxi Cancer Hospital
Taiyuan, China
The First Hospital of Shanxi Medical University
Taiyuan, China
Tianjin Cancer Hospital
Tianjin, China
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The Second Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, China
Xiangyang Central Hospital
Xiangyang, China
Northern Jiangsu People's Hospital
Yangzhou, China
General Hospital of Ningxia Medical University
Yinchuan, China
Henan Cancer Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2026
First Posted
September 16, 2026
Study Start
July 8, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
September 16, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share