NCT07087197

A Study of SKB107 in Advanced Solid Tumors With Bone Metastases

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	SKB107 for injection	177Lu-DOTA-IBA is a Radionuclide conjugated drugs (RDC) targeting bone.

Timeline

• Start date: 2025-08-15
• Primary completion: 2027-10-01
• Completion: 2028-07-01
• First posted: 2025-07-25
• Last updated: 2025-12-08

Locations

1 site across 1 country: China