Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments

April 14, 2026 updated by: Evopoint Biosciences Inc.

A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Efficacy of XNW28012 in Subjects With Advanced Solid Tumors

This is an open-label, dose escalation, multicenter, phase 1, first-in-human study of XNW28012 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies or are intolerant to such therapies. The study consists of two parts: a dose escalation part and a dose expansion part.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of University of Science and Technology of China
      • Hefei, Anhui, China
        • Recruiting
        • Second Affiliated Hospital of Anhui Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing University Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Provincial Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • Affiliated Hospital of Guizhou Medical University
    • Hebei
      • Baoding, Hebei, China
        • Recruiting
        • Affiliated Hospital of Hebei University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Affiliated Cancer Hospital of Harbin Medical University
    • Henan
      • Luoyang, Henan, China
        • Recruiting
        • First Affiliated Hospital of Henan University of Science and Technology
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
    • Jiangxi
      • Ganzhou, Jiangxi, China
        • Recruiting
        • First Affiliated Hospital of Gannan Medical College
    • Kunming
      • Yunnan, Kunming, China
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
    • Shandong
      • Binzhou, Shandong, China
        • Recruiting
        • Affiliated Hospital of Binzhou Medical College
      • Jinan, Shandong, China
        • Recruiting
        • Jinan Central Hospital
      • Linyi, Shandong, China
        • Recruiting
        • Linyi Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Provincial People's Hospital
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University school of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. For the dose escalation part: subjects with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have failed the established standard anti-cancer therapies for a given tumor type or have been intolerant to such therapies.
  2. For the dose expansion part: subjects must have a histological or cytological diagnosis of progressive, locally advanced, and/or metastatic ovarian cancer, cervical cancer, pancreatic cancer, or colorectal cancer (CRC) who have failed the following anti-cancer therapies: Ovarian cancer, Cervical cancer, Pancreatic cancer, Colorectal cancer.
  3. Age ≥ 18 years old at the time of consent.
  4. Subjects must have at least 1 measurable lesion as defined per RECIST version 1.1 (for dose expansion part only).
  5. 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 warrants discussion with the medical monitor.
  6. Subjects must have adequate organ function within 7 days prior to the first study drug administration, as indicated by the flaboratory values:
  7. Life expectancy of at least 12 weeks.
  8. Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  9. 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.
  10. Subjects are able to provide written informed consent, understand and are willing to comply with the requirements of the study.

Exclusion Criteria:

  1. A history of severe infusion reactions to other monoclonal antibodies/antibody drug conjugates (ADCs) or allergic reactions to any components of XNW28012.
  2. Any anti-tumor therapy within 28 days prior to the first dose, including but not limited to: small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or any other experimental drugs.
  3. Any active malignancy, with the exception of the specific types of cancers under investigation in this study and any locally recurring cancer that has been treated curatively .
  4. 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.
  5. 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.
  6. Subjects with toxicities (as a result of prior anti-cancer therapy) which have not improved to CTCAE grade ≤1 or stabilized, except those AEs not considered as a likely safety risk (e.g., alopecia).
  7. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack) ≤ 3 months prior to screening is allowed if stable.
  8. Any of the hematological risk factors:
  9. Subjects who are unwilling or unable to provide tumor tissue samples that meet the requirements for tissue factor (TF) expression testing.

11. Clinically significant cardiovascular/cerebrovascular conditions. 12. Active ocular surface disease at screening, or subjects with any prior episode of cicatricial conjunctivitis.

13. Any history of Toxic Epidermal Necrolysis (TEN) or Steven Johnson Syndrome. 14. Subjects who have undergone major surgery within 28 days prior to the first dose of study drug, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter [PICC] line).

and so on.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part.
Based on the toxicology data from preclinical studies, the Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part with preset doses at 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.0 mg/kg, and 7.5 mg/kg. Eligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent. The first treatment cycle will be the dose limiting toxicity (DLT) assessment period. The safety, tolerability, and occurrence of DLTs will be assessed during the DLT period. The proposed dose escalation plan is shown below.
Drug: XNW28012
Eligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ph 1: Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability].
Time Frame: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Ph 2: To evaluate the antitumor efficacy of XNW28012 at the recommended Part 2 dose.
Time Frame: through study completion, an average of 1 year
ORR per RECIST1.1 assessed by Investigators.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ph 1:Maximum tolerated dose (MTD) and/or the recommended Part 2 dose.
Time Frame: The first 21-day cycle of therapy
To determine the maximum tolerated dose (MTD) and the recommended Part 2 dose with XNW28012;
The first 21-day cycle of therapy
Ph 1/II: Maximum (peak) observed concentration (Cmax) of XNW28012.
Time Frame: through study completion, an average of 1 year
Blood samples were collected at specified intervals for the determination of Cmax.
through study completion, an average of 1 year
Ph 1/II: Maximum (peak) observed concentration (Cmax) of total antibody of XNW28012..
Time Frame: through study completion, an average of 1 year
Blood samples were collected at specified intervals for the determination of Cmax.
through study completion, an average of 1 year
Ph 1/II: Maximum (peak) observed concentration (Cmax) of YL0010014
Time Frame: through study completion, an average of 1 year
Blood samples were collected at specified intervals for the determination of Cmax.
through study completion, an average of 1 year
Ph 1/II: Anti-drug antibody (ADA)
Time Frame: through study completion, an average of 1 year
To assess the incidence of anti-drug antibody (ADA) against XNW28012
through study completion, an average of 1 year
Ph I/II：Objective response rate (ORR)
Time Frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
ORR is defined as the proportion of subjects who have a confirmed CR or a PR per RECIST 1.1 assessed by Investigator.
Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II: Disease control rate (DCR)
Time Frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Rate of complete response [CR], partial response [PR], and stable disease per RECIST1.1 assessed by Investigator.
Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II：Progression free survival (PFS)
Time Frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Progression free survival (PFS) per RECIST1.1 assessed by Investigator
Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Ph I/II: Duration of response (DOR)
Time Frame: Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).
Duration of response (DOR) per RECIST1.1 assessed by Investigator.
Efficacy assessments will be performed at screening (≤ 28 days prior to the first dose), every 6 weeks for 24 weeks after the first dose, and every 12 weeks after the 24 weeks response assessments until disease progression (up to 1 year).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ph 1/2: Tissue factor expression
Time Frame: At screening
Correlation between tissue factor expression and the antitumor efficacy of XNW28012.
At screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evopoint Biosciences Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 25, 2024

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XNW28012-I/II-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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