Actively Recruiting
SKB445 for Injection in Solid Tumors
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
126
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB445 for injection in patients with advanced solid tumors.
CONDITIONS
Official Title
SKB445 for Injection in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at the time of consent
- Male or female subjects
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- Failed, intolerant, ineligible for, or no standard therapy available
- At least one measurable lesion per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1
- Expected survival of at least 3 months
- Adequate organ and bone marrow function confirmed by lab results
- Use of effective contraception for subjects of childbearing potential
- Ability to understand and sign informed consent and comply with study visits and procedures
You will not qualify if you...
- Received anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine with anti-tumor effects) within 4 weeks or 5 half-lives of known drugs before first dose
- Major surgery within 4 weeks prior to first dose
- Known allergy to SKB445 or any of its components
- Previous or concurrent other malignancies within 3 years before first dose
- Active central nervous system metastases
- Uncontrolled or severe cardiovascular disease
- Uncontrolled systemic diseases
- HIV infection or active viral hepatitis
- History of psychiatric illness or drug abuse affecting compliance
- Prior hematopoietic stem cell or solid organ transplant
- Any other condition that may interfere with study results or compliance, as judged by investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
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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