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NCT Number: NCT07019675

A Study of SKB518 in Patients With Lung Cancer

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.

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Key information

Conditions

Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Symptomatic or uncontrolled cardiovascular disease
  • History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
  • 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.
  • Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
  • 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.

Treatment and study plan

SKB518

Drug

SKB518 is administered every 3 weeks(Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Tislelizumab

Drug

Tislelizumab is administered every 3 weeks(200 mg, Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

Other names: Tevimbra

carboplatin

Drug

Carboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles

Primary outcomes

  1. AE

    Time frame: Up to 24 months

    Incidence and severity of Adverse Events (AEs)

  2. ORR in specific arms

    Time frame: Up to 24 months

    Objective Response Rate (ORR) assessed by the investigators per RECIST v1.1

  3. PFS in specific arm

    Time frame: Up to 24 months

    Progression-Free Survival (PFS) assessed by the investigators per RECIST v1.1

Secondary outcomes

  1. PFS in specific arms

    Time frame: Up to 24 months

    Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.

  2. DOR in specific arms

    Time frame: 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.

  3. OS

    Time frame: Up to 24 months

    Time from start of treatment to death due to any reason.

  4. Pharmacokinetics

    Time frame: Up to 24 months

    Maximum and minimum drug concentrations (Cmax and Cmin) of SKB518-ADC and SKB518-TAb (antibody-drug conjugate and total antibody forms of SKB518) in Serum; Cmax and Cmin of SKB518-Free Payload in Plasma

  5. Immunogenicity

    Time frame: Up to 24 months

    Anti-Drug Antibody(ADA) Titre of SKB518

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Li

CONTACT

[email protected]

086-010-58202512

Sponsors and collaborators

Lead sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 13, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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