Cohort 2 for Solid Tumors, Adult

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gabrail Cancer & Research Center, Canton, OHSolid Tumors, AdultDecoy20 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial studies a new drug to see if it's safe & effective against advanced solid tumors.

Eligible Conditions
  • Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: Up to 2.5 years

Year 3
Percentage of subjects with Adverse Events (AEs)
Year 3
Number of Subjects with dose-limiting toxicities (DLTs)
Up to 2 years
Maximum Tolerated Dose (MTD) of Decoy20
Up to 2.5 years
Recommended Phase 2 Dose (RP2D) of Decoy20
Up to 3 years
Anti-Drug Antibodies (ADA)
Area under the concentration versus time curve (AUC) of Decoy20
Duration of Response (DoR)
Elimination half-life (t1/2) of Decoy20
Maximum drug concentration (Cmax) of Decoy20
Neutralizing Antibodies (NAbs)
Objective Response Rate (ORR)

Trial Safety

Trial Design

4 Treatment Groups

Cohort 2
1 of 4
Cohort 3
1 of 4
Cohort 1
1 of 4
Cohort 4
1 of 4

Experimental Treatment

35 Total Participants · 4 Treatment Groups

Primary Treatment: Cohort 2 · No Placebo Group · Phase 1

Cohort 2
Drug
Experimental Group · 1 Intervention: Decoy20 · Intervention Types: Drug
Cohort 3
Drug
Experimental Group · 1 Intervention: Decoy20 · Intervention Types: Drug
Cohort 1
Drug
Experimental Group · 1 Intervention: Decoy20 · Intervention Types: Drug
Cohort 4
Drug
Experimental Group · 1 Intervention: Decoy20 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2.5 years

Who is running the clinical trial?

Indaptus Therapeutics, IncLead Sponsor
Translational Drug DevelopmentOTHER
17 Previous Clinical Trials
923 Total Patients Enrolled
Indaptus TherapeuticsStudy DirectorIndaptus Therapeutics, Inc

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have already received one to three rounds of treatment for your cancer that has spread, but they did not work, or you could not tolerate them.
You are expected to live for at least three more months.

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.