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Pancreatic CancerPhase 3NCT07823049

Study of XNW28012 in Subjects With Metastatic Pancreatic Cancer Who Received Prior Systemic Therapy

A Phase 3 study testing XNW28012 for injection and XNW28012 Mimetic for Injection in people with Pancreatic Cancer, run by Evopoint Biosciences Inc. at 48 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Pancreatic Cancer
What is being tested?
XNW28012 for injection and XNW28012 Mimetic for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
226 participants
Where
48 sitesChina
Study dates
8 Jul 2025to 31 Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.
  • Major surgery, except minimally invasive procedures (e.g., peripherally inserted central catheter), was performed within 4 weeks before randomization.
  • Subjects with active hepatitis B (HBsAg and/or HbcAb positive but HBV DNA<2000 IU/mL), active hepatitis C (HCV antibody positive but HCV RNA negative), and HIV antibody positive;
  • Use of systemic antibacterial, antifungal, or antiviral agents within 14 days prior to randomization to allow antiviral therapy for subjects with viral hepatitis.
  • The presence of immunodeficiency conditions requiring treatment or systemic use of corticosteroids (≥10 mg/ day of prednisone or another corticosteroid at a pharmacologic physiological dose) or other immunosuppressive drugs within 7 days before randomization.
  • Receipt of a strong CYP3A4 inhibitor or inducer or a strong CYP2D6 inhibitor within 2 weeks or five half-lives, whichever was shorter, before the first study drug.
  • Present with the following health conditions, including but not limited to:Clinically relevant bilateral hydronephrosis that is not relieved by ureteral or percutaneous drainage;Complete biliary obstruction;the presence of acute or chronic inflammatory skin diseases;the presence of inflammatory lung disease, including but not limited to moderate/severe asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease;High risk of rupture and bleeding or GI/respiratory fistula due to tumor invasion of surrounding vital structures such as large blood vessels, trachea, etc.
  • Presence of clinical symptoms or signs of gastrointestinal obstruction within 4 weeks before randomization; A history of chronic diarrhoea, gastrointestinal perforation, fistula or bleeding; Inflammatory bowel diseases, including Crohn's disease and ulcerative colitis.
  • Presence of uncontrolled serous effusion requiring frequent drainage or medical intervention (e.g., pleural effusion, peritoneal effusion, pericardial effusion, etc.) within 14 days before randomization, requiring additional intervention within 2 weeks after intervention, excluding exfoliative cytology of exudate.
  • Pregnant, lactating women, or subjects who planned to become pregnant during the study period.
  • There are diseases that the investigator considers to be detrimental to the study treatment or interfere with the judgment of drug toxicity/adverse events; Or the presence of alcohol or drug abuse; Or subjects who, as judged by the investigator, were not compliant during the study.

Trial locations and contacts

48 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yingjie zhao contact

+86 15553136593

yingjie.zhao@evopointbio.com

48 sites in 1 country

China48 sites, 48 recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

    Recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing

    Recruiting

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing

    Recruiting

  • Affiliated Hospital of Binzhou Medical College

    Binzhou

    Recruiting

  • Hunan Cancer Hospital

    Changsha

    Recruiting

  • The First People's Hospital of Changzhou

    Changzhou

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing

    Recruiting

  • Fuyang Cancer Hospital

    Fuyang

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Recruiting

  • Union Hospital Affiliated to Fujian Medical University

    Fuzhou

    Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

    Recruiting

  • Harbin Medical University Cancer Hospital

    Ha’erbin

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei

    Recruiting

  • The First Hospital of Jilin University

    Jilin City

    Recruiting

  • Cancer Hospital Affiliated to Shandong First Medical University

    Jinan

    Recruiting

  • Jinan Central Hospital

    Jinan

    Recruiting

  • Gansu Provincial Cancer Hospital

    Lanzhou

    Recruiting

  • Meizhou People's Hospital

    Meizhou

    Recruiting

  • Jiangxi Provincial Cancer Hospital

    Nanchang

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing

    Recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing

    Recruiting

  • Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

    Nanjing

    Recruiting

  • Tumor Hospital Affiliated to Guangxi Medical University

    Nanning

    Recruiting

  • Peking University Cancer Hospital Inner Mongolia Hospital

    Neimeng

    Recruiting

  • People's Hospital Affiliated to Ningbo University

    Ningbo

    Recruiting

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality

    Recruiting

  • Shanghai East Hospital

    Shanghai

    Recruiting

  • Shanghai Fourth People's Hospital

    Shanghai

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan

    Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin

    Recruiting

  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

    Recruiting

  • The Second Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an

    Recruiting

  • Xiamen Hospital of Traditional Chinese Medicine

    Xiamen

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang

    Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
XNW28012 for injection, XNW28012 Mimetic for Injection
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XNW28012 for injectionDrug

    XNW28012 for Injection (2.4 mg/kg, administered once every 3 weeks)

  • XNW28012 Mimetic for InjectionDrug

    XNW28012 Mimetic for Injection (administered once every 3 weeks)

Study groups in NCT07823049
Study groupRoleWhat they receive
XNW28012 for injectionActive comparatorXNW28012 for injection (2.4 mg/kg, administered once every 3 weeks)
Receives: Drug: XNW28012 for injection
XNW28012 mimetic for injectionPlacebo comparatorXNW28012 Mimetic for Injection (administered once every 3 weeks)
Receives: Drug: XNW28012 Mimetic for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The time from the date of subject enrollment to the date of death from any cause

    Measured: through study completion, an average of 2 year

Secondary outcomes (11)

  1. Progression free survival (PFS)

    Progression free survival (PFS) per RECIST1.1 assessed by Investigator

    Measured: through study completion, an average of 2 year

  2. 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.

    Measured: through study completion, an average of 2 year

  3. Disease control rate (DCR)

    Rate of complete response [CR], partial response [PR], and stable disease per RECIST1.1 assessed by Investigator.

    Measured: through study completion, an average of 2 year

  4. Duration of response (DOR)

    Duration of response (DOR) per RECIST1.1 assessed by Investigator.

    Measured: through study completion, an average of 2 year

  5. Time to Response (TTR)

    Defined as the time from the date of randomization to the date of first documented complete response (CR) or partial response (PR).

    Measured: through study completion, an average of 2 year

  6. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

    Incidence and severity of adverse events that are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

    Measured: through study completion, an average of 2 year

  7. Maximum (peak) observed concentration (Cmax) of total antibody of XNW28012 TAb

    Blood samples were collected at specified intervals for the determination of Cmax.

    Measured: through study completion, an average of 2 year

  8. Anti-drug antibody (ADA)

    The incidence of positivity for anti-drug antibodies (ADA) and neutralizing antibodies (if data are available), and the impact of anti-drug antibodies (ADA) on pharmacokinetics (PK), safety, and efficacy.

    Measured: through study completion, an average of 2 year

  9. Tissue factor expression

    To evaluate the correlation between tissue factor expression in tumor tissue and the anti-tumor efficacy of XNW28012

    Measured: through study completion, an average of 2 year

  10. Maximum (peak) observed concentration (Cmax) of XNW28012

    Blood samples were collected at specified intervals for the determination of Cmax.

    Measured: through study completion, an average of 2 year

  11. Maximum (peak) observed concentration (Cmax) of YL0010014

    Blood samples were collected at specified intervals for the determination of Cmax.

    Measured: through study completion, an average of 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2026
  2. Study start8 Jul 2025
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07823049
Sponsor's protocol ID
XNW28012-III-01
Status last verified
Sep 2026
First submitted
21 Jul 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XNW28012 for injection and XNW28012 Mimetic for Injection in people with Pancreatic Cancer, run by Evopoint Biosciences Inc. at 48 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yingjie zhao (+86 15553136593, yingjie.zhao@evopointbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The time from the date of subject enrollment to the date of death from any cause (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07823049.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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