Lung Carcinoma
Conditions
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.
Interventions
DRUGSKB518
SKB518 is administered every 3 weeks(Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
DRUGTislelizumab
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.
DRUGCarboplatin
Carboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles
Sponsors
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AE | Up to 24 months | Incidence and severity of Adverse Events (AEs) |
| ORR in specific arms | Up to 24 months | Objective Response Rate (ORR) assessed by the investigators per RECIST v1.1 |
| PFS in specific arm | Up to 24 months | Progression-Free Survival (PFS) assessed by the investigators per RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS in specific arms | Up to 24 months | Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors. |
| DOR in specific arms | 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. |
| Pharmacokinetics | 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 |
| Immunogenicity | Up to 24 months | Anti-Drug Antibody(ADA) Titre of SKB518 |
Countries
China
Contacts
CONTACTXin Li
Outcome results
None listed