A Phase I Trial of SIM1811-03 in Subjects With Advanced Tumors

Launched by JIANGSU SIMCERE BIOLOGICS CO., LTD · Mar 10, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called SIM1811-03, which aims to treat patients with advanced tumors, including a type of skin cancer known as Cutaneous T Cell Lymphoma (CTCL). This is the first time this drug is being tested in humans, and the study will look at how safe it is and how well it works. The trial is open to adults aged 18 and older who have advanced solid tumors or confirmed CTCL that has not responded to previous treatments. Participants must have at least one measurable tumor and be in good overall health.

If you qualify and choose to join, you’ll receive SIM1811-03 and be closely monitored by doctors during the study. You'll need to provide some medical history and might need some tests to confirm your eligibility. It’s important to know that this trial is currently recruiting participants, and you’ll be asked to give written consent before any treatments begin. Additionally, women who could become pregnant will need to use strict contraception during the study. Your participation could contribute to important research that may help others with similar conditions in the future.

Gender

ALL

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.