NCT05569057

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a phase I trial to evaluate the safety, efficacy, and pharmacokinetic/ pharmacodynamic characteristics of SIM1811-03 in subjects with advanced solid tumors and subjects with CTCL. The trial is composed of two parts, phase Ia and phase Ib. Phase Ia is a dose escalation part to determine the MTD and/or RD of SIM1811-03. Phase Ib is a dose expansion part at RD level SIM1811-03 determined in phase Ia to primarily assess the anti-tumor activity of SIM1811-03 in subjects with solid tumors or CTCL. The tumor types in PhIb will be adjusted based on the response observed in PhIa. Approximately 50 subjects will be enrolled in this phase. Cohort 1: Patients with CTCL (approximately 20 patients). Cohort 2: Patients with advanced/metastatic solid tumors, including ovarian cancer (approximately 10 patients), NSCLC (approximately 10 patients), and hepatocellular carcinoma etc. Each subject will undergo Screening, Treatment, Safety Follow-up, and survival Follow-up periods. Any subject who has discontinued from study treatment other than disease progression will also enter PFS follow up period and to continue to have tumor assessments until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurs first. Upon completion of the safety follow up and PFS follow-up, as applicable, all patients, except those who died, withdrew consent or were lost to follow-up, will be followed for survival. Eligible subjects will receive intravenous infusion of SIM1811-03 on Days 1 and 15 of each 28-day cycle.

Conditions

• Advanced Solid Tumor
• Cutaneous T-cell Lymphoma (CTCL)

Interventions

Type	Name	Description
DRUG	SIM1811-03	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 tumors

Timeline

• Start date: 2022-09-30
• Primary completion: 2024-06-01
• Completion: 2025-03-31
• First posted: 2022-10-06
• Last updated: 2022-10-07

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study