A Phase I Trial of SIM1811-03 in Subjects with Advanced Solid Tumors and Cutaneous T-cell Lymphoma
A Phase I Trial of SIM1811-03 in Subjects with Advanced Solid Tumors and Cutaneous T-cell Lymphoma
Mechanism of Action
SIM1811-03, binds potently and selectively to TNFR2 and induces CD4 and CD8 T cell activation and proliferation. Targeting TNFR2 is anticipated to yield greater anti-tumor immunity by stimulating T-cell activation and proliferation in the tumor microenvironment than targeting other costimulatory receptors.
Purpose
- How much of the study can be given with an acceptable level of side effects • The effects of the study (good and bad)
- How much of the study is absorbed into the blood and how fast it is removed
- How the study is acting on your body
- Histologically and/or cytologically documented advanced/metastatic solid tumors or histologically confirmed CTCL;
- 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 participants with solid tumors. Tumor lesions previously treated with radiotherapy or local therapy should not be considered as measurable unless progression is documented.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Life expectancy of ≥ 12 weeks.
- Adequate organ and marrow functions 9） Provide archived or fresh biopsy tumor tissue samples or tissue sections
- Females of childbearing potential require strict contraception during the study.
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.
Patients who have ascites requiring drainage or diuretic treatment or pleural effusion or pericardial effusion requiring drainage and/or accompanied by shortness of breath within 2 weeks before the first dose of study drug treatment
Location
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