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.
This study is 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. The study is divided into two parts: Phase Ia and Phase Ib. The Phase Ia study is the dose escalation phase. The primary objective is to assess the safety and tolerability of a single administration of SKB107 and to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) based on the occurrence of Dose-Limiting Toxicities (DLTs) associated with SKB107 (if the MTD cannot be determined).The Phase Ib study is the dose expansion phase. The primary objective is to explore the optimal dose, safety, or efficacy of SKB107 at a selected dose level (confirmed as safe by the Safety Review Committee (SRC) and not exceeding the MTD or MAD)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
177Lu-DOTA-IBA is a Radionuclide conjugated drugs (RDC) targeting bone.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGIncidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Up to 3 year
Maximum plasma concentration (Cmax) of SKB107
Time frame: Up to 1 week
Dosimetry
To collec the biological distribution of major tissues/organs.
Time frame: Up to 1 week
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.
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 year
Overall survival(OS)
Time from start of treatment to death due to any reason
Time frame: Up to 3 years
symptomatic skeletal event-free survival (SSE-FS)
Time from start of treatment to the first occurrence of new SSE or death from any cause , whichever occurs first.
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.