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Decoy Receptor
Decoy20 for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Indaptus Therapeutics, Inc
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 2.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial studies a new drug to see if it's safe & effective against advanced solid tumors.
Who is the study for?
Adults with advanced metastatic solid tumors who have had 1-3 prior treatments and progressed or were intolerant. They must have measurable disease, be in good physical condition (ECOG 0 or 1), not pregnant, using effective contraception, and have a life expectancy of at least 3 months. Participants need proper heart function (LVEF ≥45%) and adequate organ function.
What is being tested?
The DECOY20 Study is testing the safety and effectiveness of a new treatment called Decoy20 for patients with advanced solid tumors. This Phase 1 trial involves gradually increasing doses to find the right balance between safety and potential benefits.
What are the potential side effects?
Specific side effects of Decoy20 are not listed but may include typical reactions seen in cancer therapies such as fatigue, nausea, immune-related responses, infusion reactions, changes in blood counts or organ functions based on its mechanism.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD) of Decoy20
Number of Subjects with dose-limiting toxicities (DLTs)
Percentage of subjects with Adverse Events (AEs)
+1 moreSecondary study objectives
Anti-Drug Antibodies (ADA)
Area under the concentration versus time curve (AUC) of Decoy20
Duration of Response (DoR)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
A single dose of Decoy20 at a dose of 200 x 10\^7 KB
Group II: Cohort 3Experimental Treatment1 Intervention
A single dose of Decoy20 at a dose of 70 x 10\^7 KB
Group III: Cohort 2Experimental Treatment1 Intervention
A single dose of Decoy20 at a dose of 20 x 10\^7 KB
Group IV: Cohort 1Experimental Treatment1 Intervention
A single dose of Decoy20 at a dose of 7 x 10\^7 KB
Group V: Cohort -3Experimental Treatment1 Intervention
A single dose of Decoy20 at a dose of 0.75 x 10\^7 Killed Bacteria (KB)
Group VI: Cohort -2Experimental Treatment1 Intervention
A single dose of Decoy20 at a dose of 1.5 x 10\^7 KB
Group VII: Cohort -1Experimental Treatment1 Intervention
A single dose of Decoy20 at a dose of 3 x 10\^7 KB
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Who is running the clinical trial?
Indaptus Therapeutics, IncLead Sponsor
Translational Drug DevelopmentOTHER
18 Previous Clinical Trials
884 Total Patients Enrolled
Indaptus TherapeuticsStudy DirectorIndaptus Therapeutics, Inc
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
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.
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