RecruitingPhase 1Phase 2NCT07811037

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

A Multicenter, Dose-Escalation and Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors


Sponsor

Beijing Sungen Biomedical Technology Co., Ltd

Enrollment

332 participants

Start Date

Aug 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SGT003 for people with advanced solid tumor. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSGT003

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.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT07811037


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