A Phase II Study of SKB571 in Patients With Lung Cancer

NCT ID: NCT07230405

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-13
• Study Completion Date: 2027-12-13

Brief 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.

Conditions

Lung Cancer (Non-Small Cell)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SKB571 monotherapy

Group Type: EXPERIMENTAL

SKB571 for injection

Intervention Type: DRUG

SKB571 for injection is administered every 3 weeks(Q3W) until radiographic disease progression,intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Interventions

SKB571 for injection

SKB571 for injection is administered every 3 weeks(Q3W) until radiographic disease progression,intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Intervention Type: DRUG

Eligibility Criteria

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.

11. Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer.

12. Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment.

13. Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment.

14. Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses > 10 mg/d or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment.

15. Any condition that, in the opinion of the investigator, will interfere with the assessment of study treatment or the safety of the subject or the interpretation of the study results.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-Sen University Cancer Center

Guangzhou, , China

Henan Cancer Hospital

Zhengzhou, , China

Countries

China

Central Contacts

Xin Li

Role: CONTACT

lixin@kelun.com

086-010-58202512

Facility Contacts

Li Zhang

Role: primary

zhangli@sysucc.org.cn

086-020-87343458

Qiming Wang

Role: primary

qimingwang1006@126.com

086-0371-65588421

Other Identifiers

SKB571-II-02

Identifier Type: -

Identifier Source: org_study_id