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RECRUITING
NCT06428331
PHASE1

A Study of SKB518 in Patients With Advanced Solid Tumors

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-07-04

Completion Date

2026-06-30

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

DRUG

SKB518 for injection

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China, China