NCT06076291

An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG1827 in Subjects With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Hangzhou Sumgen Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 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 SG1827 in subjects with Advanced Solid Tumors, refractory or resistant to standard therapy, or without available standard or curative therapy.

Detailed description

After a screening period of up to 28 days for each study phase, qualified patients will be enrolled to receive their assigned dose of SG1827, administered every three weeks (Q3W), until disease progression, intolerable toxicity or others, whichever occurs first. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for SG1827 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of SG1827 as a single agent at the MTD or RP2D.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SG1827	PhaseⅠa will use an accelerated titration and Bayesian optimal interval (AT-BOIN) design with 7 dose cohorts: 0.02mg/kg, 0.2mg/kg, 1mg/kg, 3mg/kg, 6mg/kg, 10mg/kg, and 15mg/kg by IV infusion. Accelerated titration (1 patient) will be only applied to the first cohort.

Timeline

• Start date: 2023-09-27
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2023-10-10
• Last updated: 2025-06-27

Locations

6 sites across 1 country: China