A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma

ClinicalTrials.gov ID: NCT05569057

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ClinicalTrials.gov public records Last synced Nov 12, 2026, 12:51 PM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a first in human, open-label, dose escalation and expansion Phase 1 study of SIM1811-03 in adult patients with advanced solid tumors and cutaneous T-cell lymphoma. 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 identification

NCT ID: NCT05569057
Recruitment status: Not listed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.; Industry
Enrollment: 100 participants

Conditions and interventions

Conditions

Interventions

SIM1811-03 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 30, 2022 (Estimated)
Primary completion: Jun 1, 2024 (Estimated)
Completion: Mar 31, 2025 (Estimated)
Last update posted: Oct 7, 2022

2022 – 2025

United States locations

U.S. sites: 6
U.S. states: 4
U.S. cities: 5

Facility	City	State	ZIP	Site status
Henry Ford Health	Detroit	Michigan	48202	Not yet recruiting
NYU Lagone Health	New York	New York	10016	Not yet recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Not yet recruiting
Carolina Biooncology Institute	Huntersville	North Carolina	28078	Recruiting
Mary Crowley Cancer Research	Dallas	Texas	75230	Not yet recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05569057, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 7, 2022 · Synced Nov 12, 2026