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Gastrointestinal TumorsPhase 2NCT07564466

A Study of SKB571 in Participants With Gastrointestinal Tumors

A Phase 2 study testing SKB571 for injection in people with Gastrointestinal Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 26 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastrointestinal Tumors
What is being tested?
SKB571 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
26 sitesChina
Study dates
20 May 2026to 30 Jun 2028
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Participants with other malignant tumors within 3 years before the first dose of study treatment.
  • History or current metastases to central nervous system.
  • Current uncontrolled concomitant diseases
  • Clinically severe lung damage due to complications of lung disorder
  • Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
  • A history of severe skin diseases
Show all 13Show fewer
  • Unresolved toxicity from prior anti-tumor therapy
  • Serious infection within 4 weeks before the first dose of study treatment
  • Known active pulmonary tuberculosis.
  • 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.
  • Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
  • Pregnant or breastfeeding women.
  • Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Trial locations and contacts

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

Xin Li, MD contact

86-13311373861

lixin@kelun.com

26 sites in 1 country

China26 sites, 26 recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Wei Li

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Zhenyang Liu

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Yongdong Jin

    Recruiting

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

    Li Zhang

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Yigui Chen

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ruihua Xu

    Recruiting

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Yanhong Deng

    Recruiting

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

    Hangzhou, Zhejiang, 310016

    Da Li

    Not yet recruiting

  • Tumor Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

    Yanqiao Zhang

    Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

    Lei Cong

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Changzheng Li

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

    Jun Yao

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 3300029

    Huiqing Zhang

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Anwen Liu

    Hua Wang

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

    Xia He

    Sheng Li

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Yanhong Gu

    Recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

    Yuhua Cao

    Recruiting

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

    Xiuying Xiao

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Jinglei Qu

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Jian Shi

    Fengbin Zhang

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

    Hongxia Lu

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

    Ting Deng

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

    Hui Guo

    Xiaoran Guo

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Jiayi Li

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Yan Zhao

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Ruihua Zhao

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
SKB571 for injection
Keywords
Gastrointestinal tumors
Medical subject headings
Digestive System Neoplasms

What participants receive

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

  • SKB571 for injectionDrug

    Intravenous(IV) infusion(Q3W)

Study groups in NCT07564466
Study groupRoleWhat they receive
Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJ)ExperimentalNot described
Receives: Drug: SKB571 for injection
Oesophageal Squamous Cell Carcinoma (ESCC)ExperimentalNot described
Receives: Drug: SKB571 for injection
Colorectal Adenocarcinoma (CRC)ExperimentalNot described
Receives: Drug: SKB571 for injection
Bile Duct Cancer (BTC)ExperimentalNot described
Receives: Drug: SKB571 for injection
Hepatocellular Carcinoma (HCC) or other types of gastrointestinal tumorsExperimentalNot described
Receives: Drug: SKB571 for injection

What is being measured

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

  1. Objective response rate (ORR)

    Measured: Up to approximately 24 months

Secondary outcomes (9)

  1. Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)

    Measured: Up to approximately 24 months

  2. Safety and tolerability

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results, etc.

    Measured: Up to approximately 24 months

  3. Maximum Plasma Concentration (Cmax) of SKB571-ADC

    Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma

    Measured: Up to approximately 24 months

  4. Immunogenicity

    Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum

    Measured: Up to approximately 24 months

  5. Minimum Plasma Concentration(Cmin) of SKB571-ADC

    Blood samples will be collected to determine the Cmin of SKB571-ADC in the plasma

    Measured: Up to approximately 24 months

  6. Maximum Plasma Concentration(Cmax) of SKB571-TAb

    Blood samples will be collected to determine the Cmax of SKB571-TAb in the plasma

    Measured: Up to approximately 24 months

  7. Minimum Plasma Concentration(Cmin) of SKB571-TAb

    Blood Samples will be collected to determine the Cmin of SKB571-TAb in the plasma

    Measured: Up to approximately 24 months

  8. Maximum Plasma Concentration (Cmax) of unconjugated KL610348

    Blood Samples will be collected to determine the Cmax of unconjugated KL610348 in the plasma

    Measured: Up to approximately 24 months

  9. Minimum Plasma Concentration(Cmin) of unconjugated KL610348

    Blood Samples will be collected to determine the Cmin of unconjugated KL610348 in the plasma

    Measured: Up to approximately 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 posted4 May 2026
  2. Study start20 May 2026
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion30 Jun 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07564466
Sponsor's protocol ID
SKB571-II-04
Status last verified
May 2026
First submitted
14 Apr 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SKB571 for injection in people with Gastrointestinal Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 26 sites in China.

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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Xin Li, MD (86-13311373861, lixin@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to approximately 24 months). 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 NCT07564466.

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 27 Oct 2026.

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