SKB571 in Gastrointestinal Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label Phase II trial will enroll about 120 adults with histologically confirmed gastrointestinal tumors to assess safety, tolerability, preliminary anti-tumor activity, pharmacokinetics, and immunogenicity of SKB571. Participants will receive SKB571 by injection across four cohorts, with 20–30 participants per cohort. Key endpoints include safety and tolerability, objective tumor response by RECIST v1.1, and early signals of efficacy, along with PK and immunogenicity data. The study will be conducted at three sites in China and aims to characterize the candidate across diverse gastrointestinal tumor subtypes. Enrollment is limited to those with adequate organ function, ECOG 0–1, and measurable disease, while excluding individuals with recent other malignancies, CNS metastases, or uncontrolled diseases.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chongqing University Three Gorges Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• The Sixth Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The People's Hospital of Guangxi Zhuang Autonomous Region
  Nanning, Guangxi, China Recruiting

Study contacts

• Study coordinator: Xin Li, MD
• Email: lixin@kelun.com
• Phone: 86-13311373861

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.