Actively Recruiting
A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
138
Participants Needed
15
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .
CONDITIONS
Official Title
A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years at the time of informed consent
- Diagnosed with locally advanced or metastatic solid tumors confirmed by biopsy
- Have at least one measurable tumor lesion as assessed by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of 3 months or longer
- Have adequate organ function
- Recovered from all side effects of prior therapies
- Agree to use highly effective contraception during the study treatment
- Voluntarily sign the informed consent form
You will not qualify if you...
- Known active or untreated central nervous system (CNS) metastases
- Other malignant tumors diagnosed within 3 years before the first dose
- History of major cardiovascular, cerebrovascular, or thromboembolic disease
- Known active pulmonary tuberculosis
- Infection with HIV, active viral hepatitis, hepatitis B, or hepatitis C
- Major surgery within 28 days before the first dose
- Allergy or hypersensitivity to SKB571 or its components
- Severe lung injuries due to pulmonary complications
- History of allogeneic tissue or solid organ transplant
- Uncontrolled pleural, pericardial, or ascites effusion requiring repeated drainage
- Received live vaccines within 30 days before the first dose or scheduled to receive them during the study
- Use of strong cytochrome P450 (CYP3A4) inhibitors, inducers, or BCRP inhibitors within 2 weeks or 5 half-lives before the first dose
- Received chemotherapy, immunotherapy, or biological therapy within 4 weeks before the first dose
- Active infection requiring systemic anti-infective therapy within 14 days before the first dose
- Use of systemic corticosteroids (prednisone >10 mg/day) or other immunosuppressive therapy within 14 days before the first dose
- Use of investigational agents or devices within 28 days before the first SKB571 dose
- Rapid health deterioration or ECOG score worsening before the first dose
- History of psychosis or drug abuse preventing study completion
- Any condition interfering with study treatment assessment, safety, or result interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
2
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
3
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
4
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
5
The Affliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Actively Recruiting
6
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
7
Guangxi Medical University Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
8
Si Chuan Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
9
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
10
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
11
Bei Jing Cancer Hospital
Beijing, China
Not Yet Recruiting
12
Chongqing University Cancer Hospital
Chongqing, China
Actively Recruiting
13
Shanghai East Hospital
Shanghai, China
Actively Recruiting
14
Shanghai Pulmonary Hospital
Shanghai, China
Not Yet Recruiting
15
Zhongshan Hospital
Shanghai, China
Actively Recruiting
Research Team
X
Xin Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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