To hear about similar clinical trials, please enter your email below
Trial Title:
A Phase I Trial of SIM1811-03 in Subjects With Advanced Tumors
NCT ID:
NCT05781386
Condition:
Advanced Solid Tumor
Cutaneous T Cell Lymphoma
Conditions: Official terms:
Lymphoma, T-Cell, Cutaneous
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SIM1811-03 or in combination with Sintilimab injectiont
Description:
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)
Arm group label:
SIM1811-03 monotherapy or SIM1811-03 in combination with Sintilimab injection
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Written informed consent must be obtained prior to any procedures that are not
considered standard of care.
2. ≥18 years old on the day of signing informed consent, male or female;
3. Histologically and/or cytologically documented advanced/metastatic solid tumors or
histologically confirmed CTCL;
4. Have relapsed or refractory advanced solid tumors or CTCL, whose disease has
progressed during or after standard therapy
5. At least one measurable tumor lesion (RECIST 1.1) for participants with solid
tumors. Tumor lesions previously treated with radiotherapy or local therapy should
not be considered as measurable unless progression is documented.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
7. Life expectancy of ≥ 12 weeks.
8. Adequate organ and marrow functions 9） Provide archived or fresh biopsy tumor tissue
samples or tissue sections
10) Females of childbearing potential require strict contraception during the study.
Exclusion Criteria:
1) Participated in an interventional clinical trial or has used investigational devices
within 28 days prior to first dose of study drug or received systemic anti-cancer
treatments.
2）Toxicity due to previous antineoplastic therapy has not recovered to grade 0 or 1
unless such AEs are not considered to pose safety risks.
3) Required use of corticosteroids for more than 7 consecutive days within 14 days
prior to the first dose of study treatment.
4) Participated with active or history of or risk of autoimmune disease 5) Major
surgery (except biopsy) or unhealed wound within 4 weeks prior to first dose of
study drug.
6) Other known malignancies within 2 years prior to enrollment. 7) Has known active
central nervous system (CNS) metastases. 8) History of interstitial lung disease,
drug-induced interstitial lung disease, radiation pneumonitis, symptomatic
interstitial lung disease or evidence of active pneumonia that is not considered
appropriate by the investigator.
9) Participants with a history of active pulmonary tuberculosis infection within 1 year
prior to first dose of study drug.
10) History of hemorrhagic disease requiring transfusion within the last 3 months.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guanzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ruihua Xu, MD
Phone:
86-20-8734-3468
Email:
xurh@sysucc.org.cn
Start date:
March 6, 2022
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Jiangsu Simcere Biologics Co., Ltd
Agency class:
Industry
Source:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05781386
