Actively Recruiting
A Study of SKB518 in Patients With Advanced Solid Tumors
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
150
Participants Needed
1
Research Sites
103 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, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available.
CONDITIONS
Official Title
A Study of SKB518 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at time of consent
- Histologically or cytologically confirmed advanced or metastatic solid tumor that has progressed on or is intolerant/ineligible for standard treatments
- Able to provide tumor tissue samples (fresh or archived paraffin-embedded tissue, max 2 years old) before first dose for biomarker testing
- At least one measurable lesion per RECIST v1.1, including previously irradiated lesions if progression is shown
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ and bone marrow function confirmed by labs within 7 days prior to first dose
- Recovered from previous therapy toxicities except stable chronic toxicities not considered safety risks
- Use effective contraception during the study and for 6 months after last dose if of childbearing potential
- Able to provide documented voluntary informed consent
You will not qualify if you...
- Known active or untreated central nervous system metastases or carcinomatous meningitis
- Additional progressing malignancy requiring treatment within past 5 years
- History of major cardiovascular, cerebrovascular, or thromboembolic diseases
- Serious or uncontrolled concomitant diseases
- Known active tuberculosis
- Known uncontrolled HIV infection
- Active viral hepatitis B or C
- Major surgery within 28 days prior to first dose
- Allergy or hypersensitivity to SKB518 or its excipients
- History of interstitial lung disease or non-infectious pneumonitis requiring steroids
- Serious lung injuries due to lung diseases
- History of severe dry eye syndrome
- History of allogeneic tissue or solid organ transplant
- Known uncontrollable effusion
- Vaccination with live vaccine within 30 days before first dose or planned during study
- Use of strong CYP3A4 or BCRP inhibitors within 2 weeks before first dose
- Chemotherapy, radiotherapy, immunotherapy, or biologic therapy within 4 weeks, or small molecule tyrosine kinase inhibitors, antitumor hormonal therapy, immune-stimulating therapy, or traditional Chinese medicines for antitumor treatment within 2 weeks before first dose
- Active infection requiring systemic therapy
- Disease requiring systemic corticosteroids (>10 mg/d prednisolone or equivalent) or immunosuppressive therapy within 14 days before first dose
- Participation in another investigational study or use of investigational device within 28 days before first dose
- Rapid deterioration of condition before first dose
- Known psychiatric or substance abuse disorders
- Other conditions that may interfere with safety evaluation or study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, China
Actively Recruiting
Research Team
X
Xiaoping Jin, PhD
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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