Actively Recruiting
A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
180
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors.
CONDITIONS
Official Title
A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants between 18 and 75 years old
- Histologically or cytologically confirmed advanced solid tumors with no effective or tolerable standard treatment
- Ability to provide tumor tissue sample for biomarker testing during screening
- At least one measurable tumor lesion by RECIST Version 1.1
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate blood, kidney, and liver function
- Recovery to grade 1 or less toxicity from prior anti-cancer treatments
- Agreement to use highly effective contraception throughout the study
- Ability and willingness to provide informed consent and comply with study procedures
You will not qualify if you...
- Known active central nervous system metastases, carcinomatous meningitis, leptomeningeal metastases, or spinal cord compression
- Other malignancies within 5 years before first dose
- Severe or uncontrolled diseases that may interfere with study participation
- Active hepatitis B or C, active tuberculosis, HIV positive, or AIDS
- Allergy to SKB500 components or severe hypersensitivity to other monoclonal antibodies
- History of interstitial lung disease, non-infectious pneumonia, or significant lung diseases
- History of organ or stem cell transplantation
- Uncontrolled pleural, pericardial, or abdominal effusions
- Previous treatment with antibody-drug conjugates targeting the same molecule or toxins
- Recent chemotherapy, targeted therapy, immunotherapy, or extensive radiotherapy within specified intervals before first dose
- Major surgery or severe trauma within 28 days before first dose
- Use of other clinical trial drugs within 28 days before first dose
- Previous anti-cancer or live vaccines within 28 days before first dose
- Systemic steroids or immunosuppressive treatments within 14 days before first dose
- Use of potent CYP3A4 or BCRP inhibitors or inducers within 14 days before first dose
- Pregnant or lactating females
- Any other condition that could compromise safety or study assessments in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
JILIN Cancer Hospital
Jilin, China
Actively Recruiting
Research Team
Y
Yan Qing
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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