← Back to Search

Unknown

ICM20 for Advanced Cancer

Phase 1
Recruiting
Research Sponsored by IC-MedTech Corporation
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 90 days
Awards & highlights

Study Summary

This trial will test the safety of a new oral medicine for people with advanced cancer.

Who is the study for?
Adults aged 18-70, weighing between 125 and 200 pounds, diagnosed with Chagas disease by positive serology who haven't been treated for it before. Participants must be able to swallow pills, have certain normal lab values (like hemoglobin ≥9), not be pregnant or planning pregnancy without contraception, abstain from alcohol, and give informed consent.Check my eligibility
What is being tested?
This Phase 1 trial is testing the safety and tolerability of a new oral medication called ICM20 in adults. It's an open-label study which means everyone knows they're getting ICM20 along with Benznidazole. The focus is on how people react to these drugs when taken together.See study design
What are the potential side effects?
Since this is a Phase 1 trial primarily assessing safety and tolerability, specific side effects are being monitored but may include allergic reactions to the medications or their ingredients, liver function changes due to Benznidazole, digestive issues like heartburn or ulcers related to both drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Percentage of participants on study drug at Day 28 and at Day 60
Percentage of participants with a change from baseline in blood and urine tests
Percentage of participants with a change from baseline in physical examination based on a review of systems
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Level 4Experimental Treatment2 Interventions
ICM20 and benznidazole ascending dose 4
Group II: Dose Level 3Experimental Treatment2 Interventions
ICM20 and benznidazole ascending dose 3
Group III: Dose Level 2Experimental Treatment2 Interventions
ICM20 and benznidazole ascending dose 2
Group IV: Dose Level 1Experimental Treatment1 Intervention
ICM20
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benznidazole
2011
Completed Phase 4
~4600

Find a Location

Who is running the clinical trial?

IC-MedTech CorporationLead Sponsor
1 Previous Clinical Trials
57 Total Patients Enrolled

Media Library

ICM20 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05523596 — Phase 1
Safety Concerns Research Study Groups: Dose Level 4, Dose Level 1, Dose Level 2, Dose Level 3
Safety Concerns Clinical Trial 2023: ICM20 Highlights & Side Effects. Trial Name: NCT05523596 — Phase 1
ICM20 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05523596 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial extend to members of the senior population?

"This clinical trial is targeting candidates aged 18 to 70. For those younger than the age of consent, there are 3 studies available and 24 for elderly patients over 65 years old."

Answered by AI

Has the regulatory agency sanctioned Dose Level 2?

"The safety of Dose Level 2 is estimated to be a 1, as it has only been tested in preliminary trials and there is limited evidence on its efficacy."

Answered by AI

Is this research project still recruiting participants?

"Affirmative. Clinicaltrials.gov reports that this experiment, which was first advertised on December 20th 2022, is currently recruiting participants. A total of 24 individuals need to be recruited from one single medical facility before the trial can commence."

Answered by AI

How many individuals are being incorporated into this research project?

"That is correct. As per the clinicaltrials.gov records, this clinical trial is presently soliciting patients. The initial post was made on December 20th 2022 and most recently revised then same day - 24 participants are needed to be recruited from a single site."

Answered by AI

What is the eligibility criteria for potential participants in this research?

"This clinical trial is seeking 24 individuals aged 18-70 who are contending with safety issues. In addition to this criteria, accepted participants must have a hemoglobin level of at least 9 g/dl, over 1000 polymorphonuclear white blood cells, more than 50,000 platelets & liver function tests below double the upper limit of normal; serum creatinine levels should be no higher than 2.0 and prothrombin time & partial thromboplastin time must remain within their respective norms. The human immunodeficiency virus status needs to be negative while those recruited need to weigh between 125 - 200 pounds and"

Answered by AI

What is the end goal of this research endeavor?

"According to the IC-MedTech Corporation, who is sponsoring this trial, the main outcome to be measured over a 90 day period will involve monitoring Treatment-Emergent Adverse Events. Additionally, further secondary outcomes such as clinical changes from baseline (including physical examination review of systems), vital signs fluctuations and treatment tolerance at Day 48/60 are also being assessed."

Answered by AI
~16 spots leftby Dec 2026