A Study of SKB571 in Participants With Gastrointestinal Tumors
A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Gastrointestinal Tumors
1 other identifier
interventional
120
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2026
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2026
CompletedFirst Posted
Study publicly available on registry
May 4, 2026
CompletedStudy Start
First participant enrolled
June 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
Study Completion
Last participant's last visit for all outcomes
June 30, 2028
May 4, 2026
April 1, 2026
1.2 years
April 14, 2026
April 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR)
Up to approximately 24 months
Secondary Outcomes (9)
Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)
Up to approximately 24 months
Safety and tolerability
Up to approximately 24 months
Maximum Plasma Concentration (Cmax) of SKB571-ADC
Up to approximately 24 months
Immunogenicity
Up to approximately 24 months
Minimum Plasma Concentration(Cmin) of SKB571-ADC
Up to approximately 24 months
- +4 more secondary outcomes
Other Outcomes (1)
Correlation between biomarkers and efficacy
Up to approximately 24 months
Study Arms (4)
Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJ)
EXPERIMENTALOesophageal Squamous Cell Carcinoma (ESCC)
EXPERIMENTALColorectal Adenocarcinoma (CRC)
EXPERIMENTALHepatocellular Carcinoma (HCC) or Bile Duct Cancer (BTC) or other types of gastrointestinal tumors
EXPERIMENTALInterventions
Intravenous(IV) infusion(Q3W)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 3300029, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2026
First Posted
May 4, 2026
Study Start (Estimated)
June 30, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
May 4, 2026
Record last verified: 2026-04