A Study of SKB107 in Advanced Solid Tumors With Bone Metastases
ConditionMetastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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: Subjects with advanced solid tumor bone metastases diagnosed by histology or cytology; and the subjects have failed standard treatment, or have no standard treatment, or are intolerant or not applicable to standard treatment;
Disqualifiers
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".
Trial design
Treatments tested in this trial
- SKB107 for injection
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov