Actively Recruiting
A Phase 1 Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB571 for Injection 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a first-in-human, phase 1, open-label study to evaluate SKB571 in adults with advanced or metastatic solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, immune response, and preliminary anti-tumor activity of this treatment. This early-phase trial is important to understand how the drug behaves in the body and its potential effects on tumors. Participants will receive SKB571 by injection every three weeks. Treatment will continue until the disease progresses as shown by scans, unacceptable side effects occur, the participant passes away, or treatment is stopped for other reasons. This study uses a dose escalation approach to find the appropriate dosage while monitoring safety. Throughout the study, participants will undergo various assessments including measuring responses to treatment, monitoring survival, and checking for side effects up to 24 months. The primary outcome is to track dose-limiting toxicities within 21 days after dosing. Researchers will also evaluate tumor response, progression-free survival, duration of response, and overall survival. Participants will be closely monitored with medical exams and tests to ensure safety and collect data on how the treatment affects their cancer.
CONDITIONS
Brief 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 consent
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- At least one measurable lesion by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Expected survival of 3 months or more
- Adequate organ function
- Recovered from prior therapy toxicities
- Agrees to use highly effective contraception during treatment
- Voluntarily signed informed consent form
You will not qualify if you...
- Active or untreated central nervous system metastases
- Other malignant tumors within 3 years before first dose
- History of major cardiovascular, cerebrovascular, or thromboembolic disease
- Active pulmonary tuberculosis
- HIV infection or active viral hepatitis B or C
- Major surgery within 28 days before first dose
- Allergy or hypersensitivity to SKB571 or its ingredients
- Severe lung injuries from pulmonary complications
- History of allogeneic tissue or solid organ transplant
- Uncontrolled pleural, pericardial, or ascites effusions needing repeated drainage
- Received live vaccines within 30 days before first dose or planned during study
- Used strong CYP3A4 or BCRP inhibitors or inducers within 2 weeks or 5 half-lives before first dose
- Received chemotherapy, immunotherapy, or biological therapy within 4 weeks before first dose
- Active infection requiring systemic treatment within 14 days before first dose
- Requires systemic corticosteroids or immunosuppressive therapy within 14 days before first dose
- Used investigational agents or devices within 28 days before SKB571 administration
- Rapid condition deterioration before first dose or ECOG no longer 0 or 1
- History of psychosis or drug abuse preventing study completion
- Any condition interfering with treatment assessment, safety, or study results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive SKB571 injections every 3 weeks until disease progression, intolerable toxicity, death, or discontinuation.
Visits every 3 weeks for SKB571 administration and assessments
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
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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