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Monoclonal Antibodies
SIM1811-03 for Cutaneous T-Cell Lymphoma
Phase 1
Recruiting
Research Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to an average of 2 year
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
Adults over 18 with advanced solid tumors or cutaneous T-cell lymphoma (CTCL) who have failed at least two systemic therapies. Participants must have measurable lesions, a life expectancy of more than 12 weeks, and be able to provide tissue samples. They should not have other recent malignancies, autoimmune diseases, organ transplants, or untreated central nervous system metastases.
What is being tested?
The trial is testing SIM1811-03, an experimental antibody targeting the TNFR2 receptor in patients with certain types of cancer. It's a first-in-human study where doses are increased gradually to find safe levels before expanding to more participants.
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions to monoclonal antibodies such as infusion-related reactions, immune system effects causing inflammation in various organs, fatigue, allergic responses and possibly impacts on blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to an average of 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to an average of 2 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1a: Incidence Rate of Dose-Limiting Toxicity (DLT)
Heart rate
Secondary study objectives
AUC
Cmax
Ctrough
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SIM1811-03 MonotherapyExperimental Treatment1 Intervention
All participants receive SIM1811-03 alone
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Who is running the clinical trial?
Jiangsu Simcere Pharmaceutical Co., Ltd.Lead Sponsor
73 Previous Clinical Trials
15,432 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: SIM1811-03 Monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.