A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors.
Patient can fully understand the trial, participates voluntarily, and signs informed consent form (ICF) prior to any study procedures
Patients aged 18 to 75 years at the time of ICF signature.
Phase I (dose-escalation study): Patients with advanced solid tumors confirmed histologically or cytologically, who have failed at least one standard therapy for advanced disease, are intolerant to standard therapy, or have no available standard treatment options.
Phase IIa (dose-expansion study): Patients with advanced solid tumors who have received at least first-line but not up to third-line standard systemic therapy and experienced disease progression or intolerance to such therapy.
Subjects who have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunosuppressive therapy or other anti-tumor therapy within 4 weeks prior to the first administration of the investigational product.
Subjects who have received systemic immunosuppressant therapy within 14 days prior to the first administration of the investigational product.
Subjects receiving anticoagulants such as therapeutic-dose heparin or vitamin K antagonists.
Subjects who have received any live or attenuated live vaccine within 28 days prior to the first administration of the investigational product.
Single group
SGT003
DrugDosage Form: Injection Strength: 50 mg (5 mL) per vial Dosage and Administration: Subjects will receive SGT003 (investigational product) via intravenous (IV) infusion on Day 1 (D1) of each cycle. Dose: During the Phase I dose-escalation, subjects will be dosed according to the assigned dose cohort; during the Phase IIa dose-expansion stage, subjects will be dosed according to the selected expansion dose. Duration of Administration: For each subject, the first infusion will be completed within 90 minutes. If no infusion-related reaction (IRR) and/or hypersensitivity reaction occurs, the subsequent infusion duration may be shortened to no less than 60 minutes.
Adverse Events (AEs), immune-related Adverse Events (irAEs)
This includes clinically significant changes in vital signs, physical examination, electrocardiogram, echocardiogram and clinical laboratory tests, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 6.0.
Phase I: Dose Limit Toxicity (DLTs)
Evaluated at each dose level of SGT003 graded by NCI CTCAE v6.0.
Phase I: Maximum Toxicity Dose（MTD）
The MTD is based on the incidence of DLTs
Phase I: Recommended Phase II dose (RP2D)
The RP2D is based on the results of safety、PK/PD and preliminary efficacy of SGT003 in the stage of dose escalation
Area under the plasma concentration-time curve (AUC)
area under the plasma concentration-time curve
Peak concentration (Cmax)
peak concentration
Time to peak concentration(Tmax)
time to peak concentration
Immunogenicity
ADA detection rate, ADA incidence rate, Nab detection rate (if applicable), Nab incidence rate (if applicable)
Phase I. Objective Response Rate (ORR)
Evaluated by RECIST1.1 and iRECIST, from date of randomization, until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first.
Phase I and phase IIa. Duration of Response (DOR)
Evaluated by RECIST1.1 and iRECIST, from date of randomization, until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first.
Phase I and phase IIa. Disease Control Rate (DCR)
The ratio of CR、PR and SD Evaluated by RECIST1.1 and iRECIST, whichever occurs first.
Phase I and phase IIa. Time to Response (TTR)
The period from the date of randomization to the occurrence of CR/PR，evaluated by RECIST1.1 and iRECIST, , until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first.
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