A Study of SKB107 in Advanced Solid Tumors With Bone Metastases

Description:

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.

Sponsor:

Sichuan Baili Pharmaceutical Co., Ltd.

Phase:

Phase 1

Contacts:

Yina Diao (CONTACT)

diaoyina@kelun.com

028-67252634

IBA

Isotope(s):
Target(s):
  • Bone Metabolism
Ligand Class: Small Molecules
Chelator: DOTA
Inclusion
  • The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;
  • Phase Ib: Subjects with advanced mCRPC diagnosed by histology or cytology;
  • Have adequate organ and bone marrow functions;
  • 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;
Exclusion
  • Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.
  • Known "super bone imaging".
  • Subjects with a history of radionuclide/radioactive drug allergy, or allergic to any component of the study formulation.