Actively Recruiting
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
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
90
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SKB107 in adults with advanced solid tumors that have spread to the bones. This open-label Phase I trial aims to assess the safety, tolerability, how the drug moves through and affects the body, dosimetry, and potential effectiveness of SKB107. The study is sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and involves participants aged 18 to 75 years with bone metastases from solid tumors, including metastatic castration-resistant prostate cancer in the dose expansion phase. The trial has two parts: Phase Ia, a dose escalation phase where participants receive increasing doses of SKB107 to find the maximum tolerated or administered dose while monitoring for dose-limiting toxicities; and Phase Ib, a dose expansion phase where the optimal dose identified in Phase Ia is given to evaluate safety and efficacy. SKB107 is a radionuclide conjugated drug targeting bone, administered as an injection. Phase Ia plans five dose levels, while Phase Ib uses the selected dose from Phase Ia. Bone metastases are confirmed by bone scans and imaging before treatment. Participants will undergo monitoring for adverse events, blood tests to measure drug concentration, dosimetry assessments, and imaging to track bone progression and survival outcomes over an average of up to three years. The primary outcome is the incidence and severity of adverse events graded by standard criteria. Secondary measures include drug levels, time to bone progression, progression-free survival, overall survival, and event-free survival related to skeletal symptoms. Participants must comply with visits and procedures throughout the study period from 2025 to 2028.
CONDITIONS
Brief 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 signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or less
- Expected survival period of at least 3 months
- For Phase Ia: Advanced solid tumor bone metastases confirmed by histology or cytology, with prior failure or intolerance to standard treatment
- For Phase Ib: Advanced metastatic castration-resistant prostate cancer (mCRPC) confirmed 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 function
- Use of effective medical contraceptive measures during treatment and for 6 months after last administration if of reproductive capacity
- Voluntary participation with signed informed consent and ability to comply with study visits and procedures
You will not qualify if you...
- Insufficient washout period before first administration of study drug
- Previous similar radionuclide internal irradiation treatment
- 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 below
- 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 formulation components
- Rapid clinical deterioration before first administration
- Participation in another clinical study except observational or intervention follow-up
- Any unstable disease or condition that risks safety or compliance or deemed inappropriate by investigator
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 - Single administration with follow-up up to 3 years
Participants receive a single administration of SKB107 to evaluate safety, tolerability, pharmacokinetics, dosimetry, and efficacy in advanced solid tumors with bone metastases.
Multiple visits for safety, pharmacokinetics, and dosimetry assessments within 1 week; longer-term visits for monitoring adverse events and outcomes for up to 3 years
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
Y
Yina Diao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here