CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 150 target
Drug / intervention
SKB518 for injectiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06428331
NCT06428331Phase 1RecruitingOn Track

A Phase 1, Multicenter, Open-label First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of SKB518 in Subjects With Advanced Solid Tumors

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·interventional·Posted May 24, 2024·Updated May 8, 2026

In Brief

A Phase 1 clinical trial evaluating SKB518 for injection for Advanced Solid Tumors. Currently recruiting, targeting 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 1RecruitingOverdue
20252026
First PostedMay 24, 2024
Enrollment StartJul 4, 2024
Primary CompletionJun 30, 2026
TodayJul 1, 2026
Enrollment to primary: 2.0 yearsPosted 2.1 years ago

Interventions

SKB518 for injectiondrug

SKB518 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.