A Study of SKB518 in Patients With Lung Cancer

Phase 2

Not yet recruiting

• Conditions: Lung Carcinoma
• Interventions: Drug: SKB518 for injection

• Registration Number: NCT07019675
• Lead Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Brief Summary

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-06-20
• Primary Completion: 2027-06-20
• Study Completion: 2027-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.
2. Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology, who have failed first-line standard therapy.
3. At least one measurable tumor lesion per RECIST v1.1.
4. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
5. Expected survival period ≥ 12 weeks.
6. The function of important organs meets the requirements of the protocol.

Exclusion Criteria

1. Symptomatic or uncontrolled cardiovascular disease
2. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
3. Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of >10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
4. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
5. The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SKB518 monotherapy	SKB518 for injection	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PFS	Up to 24 months	Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
DOR	Up to 24 months	Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
OS	Up to 24 months	Time from start of treatment to death due to any reason.

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Science; 🇨🇳 Beijing, China