A Study of SKB571 in Participants With Gastrointestinal Tumors

August 2, 2026 updated by: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Gastrointestinal Tumors

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 in participants with gastrointestinal tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with gastrointestinal tumors. Approximately 120 subjects will be enrolled in this study, including 4 cohorts with approximately 20-30 participants enrolled in each cohort.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

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 Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404000
        • Recruiting
        • Chongqing University Three Gorges Hospital
        • Principal Investigator:
          • Li Zhang
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Principal Investigator:
          • Yigui Chen
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Principal Investigator:
          • Jiayi Li
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • Ruihua Xu
      • Guangzhou, Guangdong, China, 510655
        • Not yet recruiting
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Principal Investigator:
          • Yanhong Deng
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Principal Investigator:
          • Yuhua Cao
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Principal Investigator:
          • Jian Shi
        • Principal Investigator:
          • Fengbin Zhang
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Tumor Hospital of Harbin Medical University
        • Principal Investigator:
          • Yanqiao Zhang
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Principal Investigator:
          • Jun Yao
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Ruihua Zhao
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Yan Zhao
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Zhenyang Liu
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Cancer Hospital
        • Principal Investigator:
          • Xia He
        • Principal Investigator:
          • Sheng Li
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • Yanhong Gu
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Anwen Liu
        • Principal Investigator:
          • Hua Wang
      • Nanchang, Jiangxi, China, 3300029
        • Not yet recruiting
        • Jiangxi Cancer hospital
        • Principal Investigator:
          • Huiqing Zhang
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Principal Investigator:
          • Wei Li
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Principal Investigator:
          • Jinglei Qu
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Hui Guo
        • Principal Investigator:
          • Xiaoran Guo
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Principal Investigator:
          • Lei Cong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Cancer Hospital of Shandong First Medical University
        • Principal Investigator:
          • Changzheng Li
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Not yet recruiting
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Xiuying Xiao
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Principal Investigator:
          • Hongxia Lu
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Sichuan Cancer hospital
        • Principal Investigator:
          • Yongdong Jin
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Principal Investigator:
          • Ting Deng

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. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
  2. Participants must have histologically or cytologically confirmed gastrointestinal tumors.
  3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Life expectancy ≥ 12 weeks as assessed by the investigator.
  6. Adequate organ and bone marrow function.
  7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
  8. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.

Exclusion Criteria:

  1. Participants with other malignant tumors within 3 years before the first dose of study treatment.
  2. History or current metastases to central nervous system.
  3. Current uncontrolled concomitant diseases
  4. Clinically severe lung damage due to complications of lung disorder
  5. Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
  6. A history of severe skin diseases
  7. Unresolved toxicity from prior anti-tumor therapy
  8. Serious infection within 4 weeks before the first dose of study treatment
  9. Known active pulmonary tuberculosis.
  10. Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
  11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
  12. Pregnant or breastfeeding women.
  13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJ)
Drug: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Experimental: Oesophageal Squamous Cell Carcinoma (ESCC)
Drug: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Experimental: Colorectal Adenocarcinoma (CRC)
Drug: SKB571 for injection
Intravenous(IV) infusion(Q3W)
Experimental: Hepatocellular Carcinoma (HCC) or Bile Duct Cancer (BTC) or other types of gastrointestinal tumors
Drug: SKB571 for injection
Intravenous(IV) infusion(Q3W)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: Up to approximately 24 months
Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Safety and tolerability
Time Frame: Up to approximately 24 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results, etc.
Up to approximately 24 months
Maximum Plasma Concentration (Cmax) of SKB571-ADC
Time Frame: Up to approximately 24 months
Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma
Up to approximately 24 months
Immunogenicity
Time Frame: Up to approximately 24 months
Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum
Up to approximately 24 months
Minimum Plasma Concentration(Cmin) of SKB571-ADC
Time Frame: Up to approximately 24 months
Blood samples will be collected to determine the Cmin of SKB571-ADC in the plasma
Up to approximately 24 months
Maximum Plasma Concentration(Cmax) of SKB571-TAb
Time Frame: Up to approximately 24 months
Blood samples will be collected to determine the Cmax of SKB571-TAb in the plasma
Up to approximately 24 months
Minimum Plasma Concentration(Cmin) of SKB571-TAb
Time Frame: Up to approximately 24 months
Blood Samples will be collected to determine the Cmin of SKB571-TAb in the plasma
Up to approximately 24 months
Maximum Plasma Concentration (Cmax) of unconjugated KL610348
Time Frame: Up to approximately 24 months
Blood Samples will be collected to determine the Cmax of unconjugated KL610348 in the plasma
Up to approximately 24 months
Minimum Plasma Concentration(Cmin) of unconjugated KL610348
Time Frame: Up to approximately 24 months
Blood Samples will be collected to determine the Cmin of unconjugated KL610348 in the plasma
Up to approximately 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between biomarkers and efficacy
Time Frame: Up to approximately 24 months
To evaluate the correlation between the expression levels of tumor-related genes in tumor tissues and efficacy
Up to approximately 24 months

Collaborators and Investigators

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

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

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)

May 20, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 26, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

August 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKB571-II-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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