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A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06725381•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 .

Detailed Description

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 solid tumors .
•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 ≥ 3 months.
•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.
•18. Subjects with a known history of psychosis or drug abuse that will preclude the subject from completing the study.
+1 more criteria

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 known active pulmonary tuberculosis.
•5. Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
•6. Subjects with major surgery within 28 days prior to the first dose.
•7. Subjects with known allergy or hypersensitivity to SKB571 or its excipients.
•8. Subjects with clinically severe lung injuries due to pulmonary complications.
•9. Subjects with a history of allogeneic tissue/solid organ transplant.
•10. Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.
+6 more criteria

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

Key Dates

Start Date

December 17, 2024

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

January 7, 2026

Enrollment

138

ESTIMATED participants

Conditions

Solid Malignancies

Interventions

SKB571

DRUG

Contacts

Xin Li

CONTACT

086-010-58302512 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: January 7, 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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A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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