CI

At a glance

ClinicalIndex Comparison Record
Phase 1Unknown· 255 target
Drug / intervention
SIM1811-03 or in combination with Sintilimab injectiontdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05781386
NCT05781386Phase 1Unknown
CompareCT.gov

An Open-label, Phase I Trial of SIM1811-03 to Assess the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics in Subjects With Advanced Tumors

Jiangsu Simcere Biologics Co., Ltd·interventional·Posted Mar 23, 2023·Updated Sep 21, 2023

In Brief

A Phase 1 clinical trial evaluating SIM1811-03 or in combination with Sintilimab injectiont for Advanced Solid Tumor and Cutaneous T Cell Lymphoma. Targeting 255 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor, Cutaneous T Cell Lymphoma
CountriesChina
Collaborators--

Timeline

Phase 1UnknownOverdue
2023202420252026
First PostedMar 23, 2023
Enrollment StartMar 6, 2022
Primary CompletionJun 30, 2025
Study CompletionDec 30, 2025
TodayJul 1, 2026
Enrollment to primary: 3.3 yearsPosted 3.3 years ago

Interventions

SIM1811-03 or in combination with Sintilimab injectiontdrug

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)