A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of BPR-6023021 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 BPR-6023021 in subjects with advanced solid tumors with bone metastases. The study is divided into two parts: Phase I and Phase II. The Phase I study is the dose escalation phase. The primary objective is to assess the safety and tolerability of a single administration of BPR-6023021 and to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) based on the occurrence of Dose-Limiting Toxicities (DLTs) associated with BPR-6023021 (if the MTD cannot be determined).The Phase II study is the dose expansion phase. The primary objective is to explore the efficacy of BPR-6023021 at a selected dose level.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
195
BPR-6023021 is a Radionuclide conjugated drugs (RDC) targeting bone.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to 1 year
Dosimetry,including Maximum plasma concentration (Cmax) of BPR-6023021
To collect the biological distribution of major tissues/organs and so on.
Time frame: Through study completion, an average of 2 year
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 2 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 2 year
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: Through study completion, an average of 2 year
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