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Clinical Trial Summary

This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available.


Clinical Trial Description

This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available. Dose escalation and de-escalation decisions are based on the mTPI-2 design and depend on the number of subjects enrolled and the number of DLTs observed at the current dose level. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06428331
Study type Interventional
Source Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Contact Xiaoping Jin, PhD
Phone 86-028-67255165
Email jinxp@kelun.com
Status Not yet recruiting
Phase Phase 1
Start date June 30, 2024
Completion date June 30, 2026

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