Trial Title:
A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma
NCT ID:
NCT05569057
Condition:
Advanced Solid Tumor
Cutaneous T-cell Lymphoma (CTCL)
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
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
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 tumors
Arm group label:
SIM1811-03 Monotherapy
Other name:
SIM0235, TNFR2 monoclonal antibody
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Written informed consent must be obtained prior to any procedures that are not
considered standard of care
- ≥18 years old on the day of signing informed consent, male or female
- Histologically and/or cytologically documented advanced/metastatic solid tumors or
histologically confirmed CTCL. Patients with lymphoma other than CTCL are not
eligible.
- Have relapsed or refractory advanced solid tumors or CTCL, whose disease has
progressed during or after standard therapy
- At least one measurable tumor lesion (RECIST 1.1) for patients with solid tumors.
Tumor lesions previously treated with radiotherapy or local therapy should not be
considered as measurable unless progression is documented.
- For patients with CTCL, the following criteria must be met:
- Have at least one measurable lesion (mSWAT criteria) , the lesion that has
previously been treated with local therapy should not be considered as
measurable unless progression is documented;
- Provide tissue from a punch biopsy of the skin at screening (except for
patients in phase Ia dose escalation phase, for whom skin biopsies is
recommended only).
- Mycosis fungoides (MF) or Sézary Syndrome (SS) (Stage IIb-IV based on Tumor
Node Metastasis Blood [TNMB] staging system for SS and MF diagnosed at
screening) failed of at least 2 prior systemic therapies
- Meet clinical criteria for systemic treatment (patients that can be treated
with radiotherapy and/or skin-directly therapies only are to be excluded)
- No current large cell transformation
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Life expectancy of ≥ 12 weeks
- Adequate organ and marrow functions
- Provide archival tumor samples or fresh tumor biopsy (mandatory for Phase Ib, and
recommended for Phase Ia)
- Females of childbearing potential require strict contraception during the study
Exclusion Criteria:
- Participated in an interventional clinical trial or has used investigational devices
within 28 days prior to first dose of study drug or received any following systemic
anti-cancer treatments:
1. cytotoxic chemotherapy, targeted therapy, immune checkpoint inhibitor within 4
weeks (such as PD-1 inhibitor, PD-L1 inhibitor, or CTLA-4 inhibitor);
2. radiotherapy within 2 weeks (palliative radiotherapy is allowed at least 1 week
before the study drug treatment).
- Toxicity and side effects (due to previous anticancer treatments) have not recovered
to ≤ grade 1, unless such AE is not considered to pose safety risks (such as hair
loss and neuropathy ≤ grade 2 caused by chemotherapy).
- Required use of corticosteroids for more than 7 consecutive days within 14 days
prior to the first dose of study treatment (> 10 mg daily prednisone equivalent for
solid tumors; > 20 mg daily prednisone equivalent for CTCL)
- Patients with active or history of or risk of autoimmune disease
- Major surgery (except biopsy) or unhealed wound within 4 weeks prior to first dose
of study drug
- Any other current or previous malignancy within the past 2 years except a)
adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of
the cervix, c) carcinoma in situ of the breast d) local prostate cancer after
radical resection and/ or definitive radiotherapy with stable prostate specific
antigen (PSA) levels for 1 years
- Has known active central nervous system (CNS) metastases
- 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
- History of immunodeficiency (including HIV infection)
- Known active hepatitis B or C infection
- Patients with clinically significant cardiovascular diseases
- History of severe allergic reaction to the study drug or excipients used in the
protocol
- Has had an allogeneic tissue/solid organ transplant or graft-versus-host disease
- Other conditions that researchers consider inappropriate for inclusion
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Henry Ford Health
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Ahmad Mattour, MD
Email:
Principal Investigator
Facility:
Name:
NYU Lagone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Salman Punekar, MD
Email:
Principal Investigator
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Thomas Marron, MD
Email:
Principal Investigator
Facility:
Name:
Carolina Biooncology Institute
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Status:
Recruiting
Investigator:
Last name:
John Powderly, MD
Email:
Principal Investigator
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Douglas Orr, MD
Email:
Principal Investigator
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Sarina Piha-Paul, MD
Email:
Principal Investigator
Start date:
September 30, 2022
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Jiangsu Simcere Pharmaceutical 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/NCT05569057
