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SIM1811-03 for Cutaneous T-Cell Lymphoma
Study Summary
This trial is testing a new drug, SIM1811-03, to see if it is safe and works against advanced solid tumors and cutaneous T-cell lymphoma.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't been in a drug trial or used experimental devices in the last 28 days.I can provide samples of my tumor for the study.I have CTCL (either Mycosis fungoides or Sézary Syndrome) and at least 2 treatments haven't worked for me.I have advanced cancer or CTCL confirmed through testing, but not other types of lymphoma.I have active cancer spread to my brain or spinal cord.I have a serious heart condition.My skin lymphoma has not changed into a more aggressive form.I have provided a skin biopsy for my cutaneous T-cell lymphoma.My organs and bone marrow are functioning well.I am 18 years or older.My side effects from cancer treatments are mild or non-existent, except for hair loss or mild neuropathy.I have never had lung conditions like interstitial lung disease or severe pneumonia.I have at least one tumor that can be measured and has not been treated with radiation unless it's grown.I haven't had cancer in the last 2 years, except for specific non-aggressive types or treated early-stage cancers.I have a measurable skin lesion from cutaneous T-cell lymphoma.I have or am at risk for an autoimmune disease.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had major surgery or any unhealed wounds in the last 4 weeks.I have received an organ or tissue transplant from another person.My cancer has returned or didn't respond to treatment and has gotten worse after standard therapy.I have CTCL and need treatment beyond just skin or radiotherapy.I am using reliable birth control during the study.I have been on corticosteroids for more than a week recently.
- Group 1: SIM1811-03 Monotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What potential results are expected from this research endeavor?
"Per the study sponsor, Jiangsu Simcere Pharmaceutical Co., Ltd., this trial seeks to measure an Objective Response Rate (ORR) within 28 days from initial dosing. Secondary endpoints include Half-life (T1/2), Progression-Free Survival (PFS), and Overall Response Rate (ORR)."
Is SIM1811-03 Monotherapy a safe treatment option for those with health issues?
"With limited data supporting the safety and efficacy of SIM1811-03 Monotherapy, our team at Power assessed it as a 1 on their risk scale."
Is recruitment ongoing for this research endeavor?
"Affirmative. Clinicaltrials.gov lists this research trial as actively recruiting, which began on September 30th 2022 and was last revised on October 6th of the same year. A hundred patients must be sourced from six different medical sites to complete the study."
What is the magnitude of participation in this medical experiment?
"To fulfil the necessary requirements of this medical study, 100 volunteers with appropriate qualifications must be recruited. These individuals may come from numerous places such as Henry Ford Health in Detroit and Carolina Biooncology Institute located in Huntersville, North carolina."
How widespread is the access to this research endeavor?
"The trial has identified 9 sites, 3 of which are Henry Ford Health in Detroit, Michigan; Carolina Biooncology Institute in Huntersville, North carolina; and NYU Lagone Health in New york. These locations alongside 6 others are currently enrolling patients for the study."
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