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

NCT07707674 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: XNW28012-I-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events (AEs)

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

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

• Incidence of Serious Adverse Events (SAEs)

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

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

Secondary Outcomes (9)

• RP2D

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

• Maximum Plasma Concentration (Cmax)

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

• Area Under the Plasma Concentration-Time Curve (AUC)

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

• Terminal Elimination Half-Life (t1/2)

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

• Time to Maximum Plasma Concentration (Tmax)

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

Study Arms (2)

XNW28012 2.0 mg/kg dose level

EXPERIMENTAL

XNW28012 2.0 mg/kg, IV, every 3 weeks (Q3W; 21-day cycles).

Drug: XNW28012

XNW 28012 2.4 mg/kg dose level

EXPERIMENTAL

XNW28012 2.4 mg/kg, IV, every 3 weeks (Q3W; 21-day cycles).

Drug: XNW28012

Interventions

XNW28012 DRUG

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.

XNW 28012 2.4 mg/kg dose level; XNW28012 2.0 mg/kg dose level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Evopoint Biosciences Inc.: lead

Study Sites (8)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

START - Midwest

Grand Rapids, Michigan, 49546, United States

Location

START - New York Long Island

Lake Success, New York, 10042, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

SCRI at Mary Crowley

Dallas, Texas, 75230, United States

Location

START - San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Yingyi Zhang

CONTACT

562-796-8006; yingyi.zhang@evopointbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 16, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)