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Decoy20 for Solid Tumors
Study Summary
This trial studies a new drug to see if it's safe & effective against advanced solid tumors.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have not had major uncontrolled bleeding or blood clot issues recently.I don't have any health or mental conditions that could make this study riskier for me.I am currently fighting an infection that needs treatment.I am 18 years old or older.I have had radiotherapy within the last 28 days.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I have another cancer besides my primary one, but it's not considered low-risk.My organs are working well, according to recent tests.I will use reliable birth control during and for 30 days after Decoy20 treatment.I have not taken more than 5 mg/day of prednisone or its equivalent in the last week.I have a genetic predisposition to HLH/MAS.I have not received a live vaccine in the last 14 days.I am not able to have children or will use effective birth control during and 30 days after treatment.I am fully active or can carry out light work.I have tried all treatments available to me, or I cannot or choose not to undergo treatment.I do not have severe heart problems or recent heart attacks.I haven't taken any experimental drugs within the last 28 days or 5 half-lives before starting the study drug.My cancer is advanced and has spread from where it started.I have recovered from side effects of previous treatments.I have or had HIV, Hepatitis B, or Hepatitis C.I have severe lung disease or my oxygen levels are low without support.I haven't had cancer treatment in the last 28 days or 5 half-lives.I have a history of serious liver conditions or have had my spleen removed.My cancer has spread to my brain.I have a serious brain condition like a stroke or uncontrolled epilepsy.
- Group 1: Cohort -1
- Group 2: Cohort -3
- Group 3: Cohort -2
- Group 4: Cohort 1
- Group 5: Cohort 2
- Group 6: Cohort 3
- Group 7: Cohort 4
- 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
Is there availability for participants to join this research project?
"The search for eligible participants is currently ongoing, as evidenced by the December 6th 2022 posting and subsequent edit found on clinicaltrials.gov."
Are there any research centers in North America that are actively conducting this clinical trial?
"This exploration into the efficacy of a new treatment is currently being conducted at 5 centres, including those in Los Angeles, Detroit and Morristown. Prospective participants should select the closest site to minimize their travelling obligations."
Have the results of Cohort 1 been validated by the FDA?
"Cohort 1's safety score is a conservative 1 due to the minimal data that exists on its efficacy and general security."
How many individuals are participating in this clinical experiment?
"Affirmative. The information on clinicaltrials.gov portrays that this medical trial is actively recruiting patients, with the original post being published December 6th 2022 and edited most recently on the same day. 35 persons will be recruited from 5 different sites for participation in this study."
What are the chief aims of this clinical experiment?
"This clinical trial, spanning a duration of up to 3 years, seeks to identify the Recommended Phase 2 Dose (RP2D) of Decoy20. Also being assessed are secondary outcomes such as Area under the concentration versus time curve (AUC), anti-drug antibodies (ADA) and maximum drug concentration (Cmax). These pharmacokinetic parameters will be determined pre-dose and post-dose on Day 28 after administering Decoy20."
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