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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
SKB107 for injection
Drug177Lu-DOTA-IBA is a Radionuclide conjugated drugs (RDC) targeting bone.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Phase 1a：Dose escalationExperimental treatment 1 intervention
Group B: Phase 1b: Dose expansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame
Up to 3 yearSecondary outcomes
1
Maximum plasma concentration (Cmax) of SKB107
Time frame
Up to 1 week2
Dosimetry
To collec the biological distribution of major tissues/organs.
Time frame
Up to 1 week3
Time to Radiographic Bone Progresion (TTRBP)
Time from start of treatment to progression of bone lesion (PD) or death, whichever occurs first, during the study period
Time frame
Through study completion, an average of 1 year.4
Radiographic progression-free survival (rPFS)
Time from start of treatment to progression of Disease (PD) or death, whichever occurs first
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov