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Metastatic Pancreatic CancerPhase 1NCT07707674

Phase I Open-Label Randomized Multicenter Study of XNW28012 Monotherapy in Metastatic Pancreatic Cancer

A Phase 1 study testing XNW28012 in people with Metastatic Pancreatic Cancer, run by Evopoint Biosciences Inc. at 8 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

A Phase I, Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of XNW28012 Monotherapy in the Treatment of Subjects with Metastatic Pancreatic Cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
XNW28012
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
8 sitesUnited States
Study dates
30 Jul 2026to 30 Apr 2028
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • subjects with histologically or cytologically confirmed metastatic PDAC, whose disease has progressed after at least 1 prior systemic therapy.
  • Age ≥ 18 years old at the time of consent.
  • Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. ECOG status of 2 can be allowed if it is a result of disease progression and warrantsdiscussion with the medical monitor.
  • Subjects must have adequate organ function within 7 days prior to the first study drug administration, as indicated by the following laboratory values;
  • Life expectancy of at least 12 weeks.
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug.
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  • Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized.
  • Subjects are able to provide written informed consent, understand and are willing to comply with the requirements of the study.
  • -

Who cannot join

  • A history of severe infusion reactions to other monoclonal antibodies/antibody drug conjugates (ADCs), or allergic reactions to any components of XNW28012, or treatment with TF-directed therapy.
  • Any anti-tumor therapy within 21 days prior to the first dose, including but not limited to: small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or any other experimental drugs.
  • Any active malignancy, with the exception of the specific types of cancersunder investigation in this study and any locally recurring cancer that has been treated curatively .
  • Have received a live vaccine within 4 weeks prior to the first dose of study drug. Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed; however, intranasal influenza vaccines will not be allowed if they are attenuated live vaccines.
  • Have received granulocyte colony stimulating factor (G-CSF) or granulocyte / macrophage colony stimulating factor support within 1 week before screening, or pegylated G-CSF within 2 weeks before screening.
  • Subjects with toxicities (as a result of prior anti-cancer therapy) that have not improved to CTCAE grade ≤ 1 or stabilized, except those AEs not considered as a likely safety risk (e.g., alopecia).
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  • Any history of pneumonitis or interstitial lung disease (ILD).
  • Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack) ≤ 3 months prior to screening is allowed if stable.
  • Any hematological risk factors.
  • Clinically significant cardiovascular/cerebrovascular conditions.
  • Subjects have known active CNS metastases and/or carcinomatous meningitis.
  • Active ocular surface disease at screening, or subjects with any prior episode of cicatricial conjunctivitis, or corneal nebula; subjects with glaucoma of CTCAE grade ≥ 2.
  • Any history of Toxic Epidermal Necrolysis (TEN) or Steven Johnson Syndrome.
  • Subjects who have undergone major surgery within 28 days prior to the first dose of study drug, except if the procedure is minimally invasive.
  • Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is higher than 500 IU/mL or subjects with positive hepatitis C virus (HCV) RNA. Inactive hepatitis B surface antigen (HbsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL), and cured hepatitis C subjects may be enrolled.
  • A known history of HIV infection or acquired immunodeficiency syndrome (AIDS).
  • Subjects with severe chronic or active infections requiring antibacterial, antifungal or antiviral therapy.
  • Known immunodeficiency or any condition that requires systemic treatment with either corticosteroids (≥ 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days before the first dose of study drug.
  • Subjects who have received (or plan to receive during the study treatment period) strong/moderate CYP3A4 inhibitors or inducers, or strong/moderate CYP2D6 inhibitors within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug.
  • Have an ongoing significant, uncontrolled medical condition.
  • Subjects who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study.
  • Underlying medical conditions or alcohol, drug abuse or dependence that, in Investigator's opinion, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or adverse events, or insufficient compliance during the study according to Investigator's judgment.

Trial locations and contacts

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

Yingyi Zhang contact

562-796-8006

yingyi.zhang@evopointbio.com

8 sites in 1 country

United States8 sites

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Cancer Care Line, +1 (216) 444-7923, CancerAnswer@ccf.org

  • SCRI at Mary Crowley

    Dallas, Texas, 75230

    Reva Schneider, MD, +1 (972) 566-3000, reva.schneider@scri.com

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Dr. Wasif Saif, +1 (800) 527-6266, saifw@karmanos.org

    New Patient Referrals

  • START - Midwest

    Grand Rapids, Michigan, 49546

    New Patient Referrals, +1 (616) 954-5554, hopeteam@startresearch.com

  • START - New York Long Island

    Lake Success, New York, 10042

    New Patient Referrals, +1 (363) 207-5160, hopeteam@startresearch.com

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    New Patient Referrals, +1 (615) 329-7640, scri.referrals@scri.com

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Coordinator Clinicial Operations Director, +1 (405) 271-1112, SCC-Clinical-Trials-Office@ouhsc.edu

  • START - San Antonio

    San Antonio, Texas, 78229

    New Patient Referrals, +1 (210) 593-5250, hopeteam@startresearch.com

Other trials in United States

About this study

Official title: A Phase I, Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of XNW28012 Monotherapy in the Treatment of Subjects With Metastatic Pancreatic Cancer

A Phase I, Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of XNW28012 Monotherapy in the Treatment of Subjects with Metastatic Pancreatic Cancer

Being tested
XNW28012
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • XNW28012Drug

    XNW28012 is an antibody-drug conjugate (ADC) composed of a humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) targeting Tissue Factor (TF) and a topoisomerase I inhibitor.

Study groups in NCT07707674
Study groupRoleWhat they receive
XNW28012 2.0 mg/kg dose levelExperimentalXNW28012 2.0 mg/kg, IV, every 3 weeks (Q3W; 21-day cycles).
Receives: Drug: XNW28012
XNW 28012 2.4 mg/kg dose levelExperimentalXNW28012 2.4 mg/kg, IV, every 3 weeks (Q3W; 21-day cycles).
Receives: Drug: XNW28012

What is being measured

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

  1. Incidence of Adverse Events (AEs)

    Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs), including assessment of severity according to CTCAE criteria.

    Measured: From the first dose of study treatment through 30 days after the last dose of study treatment.

  2. Incidence of Serious Adverse Events (SAEs)

    Number and percentage of participants experiencing treatment-emergent serious adverse events (SAEs).

    Measured: From the first dose of study treatment through 30 days after the last dose of study treatment.

Secondary outcomes (9)

  1. RP2D

    To determine the optimal dose of XNW28012 for future development

    Measured: From the first dose of study treatment through 30 days after the last dose of study treatment.

  2. Maximum Plasma Concentration (Cmax)

    Maximum observed plasma concentration of study drug following administration.

    Measured: From first dose of study treatment through 30 days after the last dose of study treatment.

  3. Area Under the Plasma Concentration-Time Curve (AUC)

    Area under the plasma concentration-time curve of study drug following administration.

    Measured: From the first dose of study treatment through 30 days after the last dose of study treatment.

  4. Terminal Elimination Half-Life (t1/2)

    Terminal elimination half-life of study drug following administration.

    Measured: From first dose of study treatment through 30 days after the last dose of study treatment.

  5. Time to Maximum Plasma Concentration (Tmax)

    Time to reach maximum observed plasma concentration of study drug following administration.

    Measured: From first dose of study treatment through 30 days after the last dose of study treatment.

  6. Incidence of Treatment-Emergent Anti-Drug Antibodies (ADA)

    Proportion of participants who develop treatment-emergent anti-drug antibodies during the study period.

    Measured: From the first dose of study treatment through 30 days after the last dose of study treatment.

  7. Objective Response Rate (ORR)

    Percentage of participants with a best overall response of complete response (CR) or partial response (PR) as assessed by investigator according to [RECIST 1.1/Lugano criteria].

    Measured: 24 months

  8. Duration of Response (DOR)

    Time from the first documented objective response (CR or PR) to disease progression or death, assessed according to [criteria].

    Measured: 24 months

  9. Progression-Free Survival (PFS)

    Time from first dose of study treatment to documented disease progression or death from any cause.

    Measured: 24 months

Timeline

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

  1. First posted16 Jul 2026
  2. Study start30 Jul 2026 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07707674
Sponsor's protocol ID
XNW28012-I-03
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XNW28012 in people with Metastatic Pancreatic Cancer, run by Evopoint Biosciences Inc. at 8 sites in United States.

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 9 inclusion and 22 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Yingyi Zhang (562-796-8006, yingyi.zhang@evopointbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: From the first dose of study treatment through 30 days after the last dose of study treatment.). The study lists 2 primary outcomes in all. 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 NCT07707674.

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 22 Jul 2026.

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