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ACTIVE NOT RECRUITING
NCT06076291
PHASE1

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

Sponsor: Hangzhou Sumgen Biotech Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2023-09-27

Completion Date

2026-12-31

Last Updated

2025-06-27

Healthy Volunteers

No

Interventions

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.

Locations (6)

The Affiliated Hospital of USTC

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Henan Cancer Hospital

Zhenzhou, Henan, China

The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Changsha, Hunan, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China