Phase I Study of SKB107 for Injection to Assess Safety and Effectiveness in Adults with Advanced Solid Tumors and Bone Metastases

What this Trial Is About

Researchers are evaluating SKB107 in adults with advanced solid tumors that have spread to the bones. This open-label Phase I trial aims to assess the safety, tolerability, how the drug moves through and affects the body, dosimetry, and potential effectiveness of SKB107. The study is sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and involves participants aged 18 to 75 years with bone metastases from solid tumors, including metastatic castration-resistant prostate cancer in the dose expansion phase. The trial has two parts Phase Ia, a dose escalation phase where participants receive increasing doses of SKB107 to find the maximum tolerated or administered dose while monitoring for dose-limiting toxicities and Phase Ib, a dose expansion phase where the optimal dose identified in Phase Ia is given to evaluate safety and efficacy. SKB107 is a radionuclide conjugated drug targeting bone, administered as an injection. Phase Ia plans five dose levels, while Phase Ib uses the selected dose from Phase Ia. Bone metastases are confirmed by bone scans and imaging before treatment. Participants will undergo monitoring for adverse events, blood tests to measure drug concentration, dosimetry assessments, and imaging to track bone progression and survival outcomes over an average of up to three years. The primary outcome is the incidence and severity of adverse events graded by standard criteria. Secondary measures include drug levels, time to bone progression, progression-free survival, overall survival, and event-free survival related to skeletal symptoms. Participants must comply with visits and procedures throughout the study period from 2025 to 2028.

A Study of SKB107 in Advanced Solid Tumors With Bone Metastases