ClinicalTrials.gg
RecruitingNCT07823049Updated Sep 16, 2026

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

A Phase 3 interventional study of XNW28012 for injection and XNW28012 Mimetic for Injection in Pancreatic Cancer, sponsored by Evopoint Biosciences Inc.. Recruiting at 48 sites in China. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Evopoint Biosciences Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jul 2025, registered Jul 2026).
  • Started Jul 2025; still recruiting 1 year 4 months later.

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Phase
Phase 3
Study type
Interventional
Enrollment
226
Allocation
Randomized
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 629 studies in Pancreatic Neoplasms with a site in China — 334 open to participants now, 359 under way, 30 of them phase 3. Pancreatic Neoplasms · China.

Planned enrollment
89th of 507
226 · median 58
Started
2025
with 83 others
Phase 3
41 of 629
22 open now
Primary completion
2027-05
later than 233 of 358 live
Registered
607th of 629
by date

Among the 629 studies in Pancreatic Neoplasms with a site in China, this one is the 89th largest by planned enrollment of the 507 interventional ones that give a count, is one of 84 that started in 2025, is one of 41 in phase 3, reaches primary completion later than 233 of the 358 other live ones, and was the 607th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,006 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

334 of the 629 studies in Pancreatic Neoplasms with a site in China are open now. Recruiting first, the newest first:

329 more — sign in →

All 334 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Pancreatic Cancer
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 . At least one met 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.
  • (ECOG) performance status 0-2.
  • Subjects had to have adequate levels of organ function within 7 days before randomization.
  • Female subjects of 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 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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 , 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 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 score increase of ≥1 point from the ICF signing score or a weight loss of ≥10%.
  • Subjects who have not recovered to 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 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 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 (NYHA) class 3-4 congestive heart failure;Abnormal 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 (LVEF) \< 50%.
  • Subjects with central nervous system (CNS) 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 (HBsAg and/or HbcAb positive but HBV DNA\<2000 IU/mL), active (HCV antibody positive but HCV RNA negative), and 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 (≥10 mg/ day of prednisone or another corticosteroid at a pharmacologic physiological dose) or other drugs within 7 days before randomization.
  • Receipt of a strong 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, (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.

Terms in these criteria, in plain language(23)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
226 participants (estimated)

Study arms

  • Active comparator
    XNW28012 for injection

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

    Drug: XNW28012 for injection

  • Placebo comparator
    XNW28012 mimetic for injection

    XNW28012 Mimetic for Injection (administered once every 3 weeks)

    Drug: XNW28012 Mimetic for Injection

Interventions

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

  • DrugXNW28012 Mimetic for Injection

    XNW28012 Mimetic for Injection (administered once every 3 weeks)

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Progression free survival (PFS)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: through study completion, an average of 2 year

  4. Duration of response (DOR)

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

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: through study completion, an average of 2 year

07

Study locations

48 of 48 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for May 2027, 22 months after the start.

Of 84 phase 3 interventional studies under Pancreatic Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 77. This study's planned 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2026
First posted
Sep 16, 2026
StartActual
Jul 8, 2025
Primary completionEst.
May 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07823049
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
Jul 8, 2025
Primary completion
May 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Yingjie zhao
Contact
yingjie.zhao@evopointbio.com
+86 15553136593

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Anti-TF/TOP1i Antibody-drug Conjugate XNW28012

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