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New treatment option for Metastatic Solid Tumors
Official title A Study of SKB107 in Advanced Solid Tumors With Bone Metastases
ClinicalTrials.gov ID: NCT07087197
What this study is testing
What is SKB107 for injection?
SKB107 for injection is an investigational medicine, being studied as a potential treatment for metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The age should be between 18 years and 75 years at the time of signing the informed consent form (ICF);
- The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;
- The expected survival period should be ≥ 3 months;
- Phase Ia: people with advanced solid tumor bone metastases diagnosed by histology or cytology; and the people have failed standard treatment, or have...
- Phase Ib: people with advanced mCRPC diagnosed by histology or cytology;
You likely can't join if
- The washout period before the first administration of the study drug was insufficient.
- Previous received similar radionuclide internal irradiation treatment.
- Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.
- Known "super bone imaging".
- Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.
- Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug.
See the full eligibility criteria
- The age should be between 18 years and 75 years at the time of signing the informed consent form (ICF);
- The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;
- The expected survival period should be ≥ 3 months;
- Phase Ia: people with advanced solid tumor bone metastases diagnosed by histology or cytology; and the people have failed standard treatment, or have no standard treatment, or are intolerant or not applicable to...
- Phase Ib: people with advanced mCRPC diagnosed by histology or cytology;
- Before the first administration, a 99mTc-MDP bone scan diagnosed multiple bone metastases, and at least one site was confirmed by CT or MRI;
- Have adequate organ and bone marrow functions;
- For people with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration;
- The people voluntarily join this study, sign the informed consent form, and can comply with the visit and related procedures stipulated in the protocol.
- The washout period before the first administration of the study drug was insufficient.
- Previous received similar radionuclide internal irradiation treatment.
- Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.
- Known "super bone imaging".
- Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.
- Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug.
- Poorly controlled diabetes and hypertension.
- The toxicity of previous anti-tumor treatment before the first administration has not recovered to ≤ 1 grade (evaluated based on NCI-CTCAE v5.0) or has not reached the level specified in the inclusion/exclusion criteria.
- Had other malignant tumors within 3 years before the first administration.
- people with severe and/or uncontrolled concomitant diseases.
- Active hepatitis B or active hepatitis C.
- Human immunodeficiency virus (HIV) test positive or having a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection.
- people with a history of radionuclide/radioactive drug allergy, or allergic to any component of the study formulation.
- During the screening process before the first administration, the condition deteriorated rapidly, such as significant changes in the investigator's assessment of physical condition, etc.
- people participating in another clinical study, unless it is an observational (non-treatment) clinical study or the follow-up period of an intervention study.
- Any unstable disease or clinical condition, or any condition that may endanger the safety of the subject or affect the subject's compliance, or any other conditions that the investigator deems inappropriate for...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.