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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer (Non-Small Cell)
• Intervention / Treatment: Drug: SKB571 for injection

• Study Type: Interventional
• Enrollment (Estimated): 295
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xin Li; Phone Number: 086-010-58202512; Email: lixin@kelun.com

Study Locations

• China
  • Guangzhou, China
    • Not yet recruiting
    • Sun Yat-sen University Cancer Center
    • Contact: Li Zhang; Phone Number: 086-020-87343458; Email: zhangli@sysucc.org.cn
  • Zhengzhou, China
    • Recruiting
    • Henan Cancer Hospital
    • Contact: Qiming Wang; Phone Number: 086-0371-65588421; Email: qimingwang1006@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SKB571 monotherapy	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE	Incidence and severity of adverse events (AEs)	Up to 24 months
ORR	Objective response rate (ORR) (assessed by the investigators as per RECIST v1.1)	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.	Up to 24 months
DOR	Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.	Up to 24 months
OS	Time from start of treatment to death due to any reason.	Up to 24 months
DCR	Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1)	Up to 24 months

Collaborators and Investigators

• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): January 19, 2028
• Study Completion (Estimated): January 19, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: SKB571-II-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No