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New drug candidate takes aim at Hard-to-Treat pancreatic cancer

NCT ID NCT07823049

Disease control Sponsor: Evopoint Biosciences Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing an experimental injectable drug called XNW28012 in people with metastatic pancreatic cancer that has worsened after two standard chemotherapy regimens. The phase III trial plans to enroll 226 adults and randomly assigns them in a 2:1 ratio to receive either XNW28012 or a placebo, both given every three weeks alongside best supportive care such as nutrition, electrolyte balance, and pain management. The main question is whether the drug helps people live longer than placebo. The study also tracks how long participants live without their cancer getting worse and how their tumors respond.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XNW28012, an experimental injectable drug given every three weeks
What this could lead to
If it works, XNW28012 could become a new option for people with metastatic pancreatic cancer whose cancer has grown after standard chemotherapy.
What could go wrong
Pancreatic cancer is hard to treat and many experimental drugs fail in phase III testing. Participants receive either the drug or a placebo, so some may not get the active treatment, and the drug can cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 226 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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 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. * 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.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Binzhou Medical College

    RECRUITING

    Binzhou, China

  • Anhui Provincial Cancer Hospital

    RECRUITING

    Hefei, China

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Beijing Tsinghua Changgung Hospital

    RECRUITING

    Beijing, China

  • Cancer Hospital Affiliated to Shandong First Medical University

    RECRUITING

    Jinan, China

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, China

  • Fudan University Cancer Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, China

  • Fuyang Cancer Hospital

    RECRUITING

    Fuyang, China

  • Gansu Provincial Cancer Hospital

    RECRUITING

    Lanzhou, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Ha’erbin, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, China

  • Jiangsu Cancer Hospital

    RECRUITING

    Nanjing, China

  • Jiangsu Provincial People's Hospital

    RECRUITING

    Nanjing, China

  • Jiangxi Provincial Cancer Hospital

    RECRUITING

    Nanchang, China

  • Jinan Central Hospital

    RECRUITING

    Jinan, China

  • Liaoning Cancer Hospital

    RECRUITING

    Shenyang, China

  • Meizhou People's Hospital

    RECRUITING

    Meizhou, China

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

    RECRUITING

    Nanjing, China

  • Northern Jiangsu People's Hospital

    RECRUITING

    Yangzhou, China

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

    RECRUITING

    Beijing, China

  • Peking University Cancer Hospital Inner Mongolia Hospital

    RECRUITING

    Neimeng, China

  • People's Hospital Affiliated to Ningbo University

    RECRUITING

    Ningbo, China

  • Shanghai East Hospital

    RECRUITING

    Shanghai, China

  • Shanghai Fourth People's Hospital

    RECRUITING

    Shanghai, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, China

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

    RECRUITING

    Hangzhou, China

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

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, China

  • The First Hospital of Jilin University

    RECRUITING

    Jilin City, China

  • The First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, China

  • The First People's Hospital of Changzhou

    RECRUITING

    Changzhou, China

  • The Second Affiliated Hospital of Xi 'an Jiaotong University

    RECRUITING

    Xi'an, China

  • Tianjin Cancer Hospital

    RECRUITING

    Tianjin, China

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

    RECRUITING

    Wuhan, China

  • Tumor Hospital Affiliated to Guangxi Medical University

    RECRUITING

    Nanning, China

  • Union Hospital Affiliated to Fujian Medical University

    RECRUITING

    Fuzhou, China

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

    RECRUITING

    Wuhan, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, China

  • Xiamen Hospital of Traditional Chinese Medicine

    RECRUITING

    Xiamen, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, China

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