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

NCT06076291 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-06-27

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Hangzhou Sumgen Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06076291 on ClinicalTrials.gov