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A Phase II Study of SKB571 in Patients With Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Phase II Study of SKB571 in Patients With Lung Cancer

A Phase II Study to Evaluate the Safety and Efficacy of SKB571 in Patients With Advanced Non-small Cell Lung Cancer

NCT07230405•Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Summary

This is a multicenter, phase II study. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of SKB571 in patients with advanced non-small cell lung cancer. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects aged 18-75 years at the time of signing the informed consent form
•2. Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC .
•3. Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
•4. Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
•5. Subjects who are assessed by the investigator to have an expected survival of ≥ 12 weeks.
•6. Subjects who have adequate organ function.
•7. Subjects who have recovered from all toxicities due to prior therapy .
•8. Male and female subjects must agree to use highly effective contraception methods during the study treatment.
•9. Subjects who voluntarily sign the informed consent form.

Exclusion Criteria

•1. Subjects with known active or untreated central nervous system (CNS) metastases.
•2. Subjects with other malignant tumors within 3 years prior to the first dose.
•3. Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
•4. Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
•5. Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.
•6. Subjects with known allergy or hypersensitivity to SKB571 or its excipients.
•7. Subjects with clinically severe lung injuries due to pulmonary complications.
•8. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
•9. Subjects with major surgery within 28 days prior to the first dose.
•10. Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study.
+5 more criteria

Locations (2)

Sun Yat-Sen University Cancer Center

Guangzhou, China

Henan Cancer Hospital

Zhengzhou, China

Key Dates

Start Date

January 19, 2026

Primary Completion Date

January 19, 2028

Completion Date

January 19, 2028

Last Updated

February 6, 2026

Enrollment

190

ESTIMATED participants

Conditions

Lung Cancer (Non-Small Cell)

Interventions

SKB571 for injection

DRUG

Contacts

Xin Li

CONTACT

086-010-58202512 lixin@kelun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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