A Phase II Study of SKB571 in Patients With Lung Cancer
ConditionLung Cancer (Non-Small Cell)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects aged 18-75 years at the time of signing the informed consent form
Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC .
Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
Disqualifiers
Subjects with known active or untreated central nervous system (CNS) metastases.
Subjects with other malignant tumors within 3 years prior to the first dose.
Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
Trial design
Design model
Single group
Treatments tested in this trial
SKB571 for injection
DrugSKB571 for injection is administered every 3 weeks(Q3W) until radiographic disease progression,intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Treatment groups
295 Participants
are divided into 1 treatment groupGroup A: SKB571 monotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
AE
Incidence and severity of adverse events (AEs)
Time frame
Up to 24 months2
ORR
Objective response rate (ORR) (assessed by the investigators as per RECIST v1.1)
Time frame
Up to 24 monthsSecondary outcomes
1
PFS
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Time frame
Up to 24 months2
DOR
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Time frame
Up to 24 months3
OS
Time from start of treatment to death due to any reason.
Time frame
Up to 24 months4
DCR
Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1)
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov