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RECRUITING
NCT06725381
PHASE1

A Phase 1 Study of SKB571 in Subjects 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 study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .

Official title: A Phase 1 Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB571 for Injection in Subjects With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2024-12-17

Completion Date

2027-12

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DRUG

SKB571

SKB571 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Locations (15)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Affliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Shandong Cancer Hospital

Jinan, Shandong, China

Guangxi Medical University Cancer Hospital

Linyi, Shandong, China

Si Chuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Bei Jing Cancer Hospital

Beijing, China

Chongqing University Cancer Hospital

Chongqing, China

Shanghai East Hospital

Shanghai, China

Shanghai Pulmonary Hospital

Shanghai, China

Zhongshan Hospital

Shanghai, China