RecruitingPhase 1NCT06725381

A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors

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


Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Enrollment

138 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

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 .


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SKB571 for people with solid malignancies. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSKB571

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

View Full Details on ClinicalTrials.gov

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NCT06725381


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