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A Phase I Trial of SIM1811-03 in Subjects With Advanced Tumors

NCT05781386 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2023-09-21

No results posted yet for this study

Summary

This is a first in human, open-label, dose escalation and expansion Phase I study of SIM1811-03 in adult patients with advanced tumors. SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors.

Conditions

Interventions

DRUG

SIM1811-03 or in combination with Sintilimab injectiont

SIM1811-03 is a first-in-class igG-1 based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumor. Sintilimab is an IgG4 humanized monoclonal antibody against programmed cell death protein 1 (PD-1)

Sponsors & Collaborators

  • Jiangsu Simcere Biologics Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Ruihua Xu, MD · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-06
Primary Completion
2025-06-30
Completion
2025-12-30

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 NCT05781386 on ClinicalTrials.gov