Trials / Unknown
UnknownNCT05781386
A Phase I Trial of SIM1811-03 in Subjects With Advanced Tumors
An Open-label, Phase I Trial of SIM1811-03 to Assess the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics in Subjects With Advanced Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 255 (estimated)
- Sponsor
- Jiangsu Simcere Biologics 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 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.
Detailed description
This is a phase I trial to evaluate the safety, efficacy, and pharmacokinetic/ pharmacodynamic characteristics of SIM1811-03 in participants with advanced tumors. The trial is composed of two parts, Part I and Part II. Part I is a dose escalation part to determine the MTD and/or RD of SIM1811-03 or SIM1811-03 in combination with Sintilimab Injection . Part II is a dose expansion part at RD level SIM1811-03 determined in Part I to assess the anti-tumor activity of SIM1811-03 or SIM1811-03 in combination with Sintilimab Injection in participants with advanced solid tumors or CTCL. The tumor types in Part II will be adjusted based on the response observed in Part I.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2022-03-06
- Primary completion
- 2025-06-30
- Completion
- 2025-12-30
- First posted
- 2023-03-23
- Last updated
- 2023-09-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05781386. Inclusion in this directory is not an endorsement.