NCT06167486

SG2918 For Advanced Malignant Tumors

A Phase I Clinical Study to Evaluate the Safety Tolerability and Preliminary Efficacy of SG2918 in Subjects With Advanced Malignant Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Hangzhou Sumgen Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, open-label, dose escalation and dose expansion study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 in subjects with Advanced Malignant Tumors who are refractory or resistant to standard therapy, or without available standard or curative therapy.

Detailed description

The study consists of dose escalation and dose expansion, the dose escalation will be performed in a standard 3+3 manner at the dose of 0.1mg/kg、0.5mg/kg、1 mg/kg、1.5mg/kg、2 mg/kg、2.5mg/kg and 3 mg/kg, and the dose expansion will be done in specific tumor types. Patients enrolled in the study will receive SG2918 treatment every three weeks (Q3W), until disease progression, intolerable toxicity or others, whichever occurs first.

Conditions

• Advanced Malignant Tumors

Interventions

Type	Name	Description
DRUG	SG2918	The SG2918 will be administrated by intravenous infusion every 3 weeks

Timeline

• Start date: 2023-12-26
• Primary completion: 2025-11-11
• Completion: 2026-12-28
• First posted: 2023-12-12
• Last updated: 2026-03-09

Locations

6 sites across 1 country: China