A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
ConditionSolid Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .
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 solid tumors .
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 known active pulmonary tuberculosis.
Trial design
Design model
Single group
Treatments tested in this trial
SKB571
DrugSKB571 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
Treatment groups
138 Participants
are divided into 1 treatment groupGroup A: Dose escalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of subjects achieving Dose-limiting toxicity (DLT)
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Time frame
From data of initial dose until up to 21 days for treatmentSecondary outcomes
1
Objective Response Rate (ORR)
The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases.
Time frame
Up to 24 months2
Progression Free Survival (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 months3
Duration of Response (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 months4
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov