Non-Small Cell Lung Cancer
Conditions
Interventions
Part 1 Dose Selection dose 1:JSKN033 is administered at the predefined dose 1,once per treatment cycle.
Part 1 Dose Selection dose 2:JSKN033 is administered at the predefined dose 1,once per treatment cycle.
Part 1 Cohort Expansion:JSKN033 is administered at the predefined dose,once per treatment cycle.
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects can understand the informed consent form,voluntarily participate in the study, and sign the informed consent form. 2. Subjects are >=18 years old on the day of signing the informed consent form, regardless of gender. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Expected survival time >=3 months. 5. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (per AJCC 8th Edition Lung Cancer TNM Staging) that is not eligible for curative surgery and/or curative radiotherapy. 6. NSCLC confirmed to be no other known driver gene alterations for which first- line targeted therapy has been approved. 7. For Part 1(Dose Selection): Enrolled subjects are those with advanced unresectable or metastatic NSCLC who have failed or are intolerant to standard previous treatments, and have HER2 mutation or HER2 expression in tumor tissue. 8. For Part 2(Cohort Expansion): Enrolled subjects are those with locally advanced or metastatic NSCLC who have not received prior systemic anti-tumor treatment for their advanced disease. 9. Per RECIST 1.1 criteria,subjects have at least one extracranial measurable lesion at baseline. 10. Subjects must provide tumor tissue samples. 11. Sufficient organ function. 12. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use highly effective contraceptive measures from the time of signing the informed consent form until 24 weeks after the last dose.
Exclusion criteria
Exclusion criteria: 1. Presence of any small cell carcinoma component in the histological pathology. 2. History of other malignant tumors within 5 years prior to the first dose administration. 3. History of brainstem, meningeal, or spinal cord metastases/compression, or carcinomatous meningitis; presence of active brain metastases. 4. Imaging during the screening phase shows tumor invasion, compression, or location in surrounding vital organs. 5. Sufficient washout period from previous treatments prior to the first dose. 6. Presence of the following lung diseases or medical history leading to severe respiratory impairment. 7. Presence of risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia. 8. Presence of cardiovascular and cerebrovascular diseases or risk factors. 9. Presence of uncontrolled infections. 10. Toxicity from previous anti-tumor treatment has not recovered to grade=1 (per CTCAE v5.0). 11. Previous history of allogeneic bone marrow or organ transplantation. 12. Known allergy to any component of the study drug. 13. Pregnant and/or lactating women, or women planning to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc.; abnormalities in physical examination findings, laboratory tests, electrocardiograms (ECGs), and other safety assessments;;Objective response rate (ORR) assessed by investigators per RECIST 1.1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR), disease control rate (DCR), clinical benefit rate (CBR), and progression-free survival (PFS) assessed by investigators per RECIST 1.1; overall survival (OS);PK parameters of the investigational drug JSKN033, including but not limited to: maximum concentration (Cmax), time to maximum concentration (Tmax), trough concentration (Ctrough), area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t), volume of distribution (V), elimination half-life (t1/2), clearance (CL), accumulation index (Rac), mean residence time (MRT), etc;Incidence of anti-drug antibodies (ADAs), antibody titers, and incidence of neutralizing antibodies (NAbs, if applicable); | — |
Countries
China
Contacts
Public ContactLin Wu
Hunan Cancer Hospital
Outcome results
None listed