Actively Recruiting
A Study of SKB107 in Advanced Solid Tumors With Bone Metastases
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
90
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of SKB107 in subjects with advanced solid tumors with bone metastases.
CONDITIONS
Official Title
A Study of SKB107 in Advanced Solid Tumors With Bone Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or less
- Expected survival of at least 3 months
- For Phase Ia: Advanced solid tumor bone metastases diagnosed by histology or cytology, with failed or no standard treatment or intolerance to standard treatment
- For Phase Ib: Advanced metastatic castration-resistant prostate cancer diagnosed by histology or cytology
- Multiple bone metastases confirmed by 99mTc-MDP bone scan and at least one site confirmed by CT or MRI
- Adequate organ and bone marrow functions
- Use of effective contraceptive measures during treatment and for 6 months after last dose if of reproductive capacity
- Ability to voluntarily join the study, sign informed consent, and comply with study visits and procedures
You will not qualify if you...
- Insufficient washout period before first study drug administration
- Previous treatment with similar radionuclide internal irradiation
- Previous or planned semi-body external radiotherapy targeting bone metastases during study
- Known "super bone imaging"
- Known spinal cord compression or signs suggesting impending spinal cord compression
- Cardiovascular or cerebrovascular diseases or risk factors affecting study drug treatment
- Poorly controlled diabetes or hypertension
- Toxicity from previous anti-tumor treatment not recovered to grade 1 or less
- Other malignant tumors within 3 years before first administration
- Severe or uncontrolled concomitant diseases
- Active hepatitis B or C
- Positive HIV test or history of AIDS; active syphilis infection
- History of allergy to radionuclide/radioactive drugs or study drug components
- Rapid deterioration in condition before first administration
- Participation in another clinical study except observational or follow-up studies
- Unstable disease or clinical conditions endangering safety or compliance, or deemed inappropriate by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
Y
Yina Diao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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