A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors
SGT003: Dosage 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.
Study summary
A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patient can fully understand the trial, participates voluntarily, and signs informed consent form (ICF) prior to any study procedures
2. Patients aged 18 to 75 years at the time of ICF signature.
3. Study population:
* 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.
4. ECOG 0 or 1.
5. Radiographic evidence (CT/MRI, etc.) of disease progression documented during or after the most recent prior treatment.
6. Patients must have adequate bone marrow reserve and organ function.
Exclusion Criteria:
1. 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.
2. Subjects who have received systemic immunosuppressant therapy within 14 days prior to the first administration of the investigational product.
3. Subjects receiving anticoagulants such as therapeutic-dose heparin or vitamin K antagonists.
4. Subjects who have received any live or attenuated live vaccine within 28 days prior to the first administration of the investigational product.
5. Subjects who have undergone major surgery within 4 weeks prior to the first administration of the investigational product.
6. Subjects with a history of Grade ≥3 immune-related adverse events (irAEs), hypersensitivity reactions, or Grade ≥2 immune-related myocarditis.
7. Subjects with active autoimmune disease or prior autoimmune disease with a risk of recurrence. Exceptions: well-controlled type 1 diabetes, hypothyroidism controlled solely by hormone replacement therapy, and skin diseases that do not require systemic treatment.
8. Subjects with current or prior active interstitial lung disease (ILD). Subjects with radiation-induced pulmonary fibrosis that does not require steroid therapy are eligible.
Primary outcome measure(s)
Adverse Events (AEs), immune-related Adverse Events (irAEs) — First dose up to 28 days (+3 days) after EOT, or prior to initiation of other anti-tumor therapy, whichever occurs first. 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) — Within the first dose cycle (Day1-Day21) of SGT003 Evaluated at each dose level of SGT003 graded by NCI CTCAE v6.0.
Phase I: Maximum Toxicity Dose（MTD） — Within the first dose cycle (Day1-Day21) of SGT003 The MTD is based on the incidence of DLTs
Phase I: Recommended Phase II dose (RP2D) — Within the first dose cycle (Day1-Day21) of SGT003 The RP2D is based on the results of safety、PK/PD and preliminary efficacy of SGT003 in the stage of dose escalation
Phase IIa: Objective Response Rate (ORR) — 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. average Up to 24 months The ratio of CR and PR Evaluated by RECIST1.1 and iRECIST,
Trial sites (1)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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