ICM20 for Advanced Cancer

Recruiting at 2 trial locations

Overseen By IC-MedTech Medical Affairs

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: IC-MedTech Corporation

Must not be taking: Amiodarone, MAO inhibitors, others

Disqualifiers: Heart failure, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 60 days

13 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 1 Non-Randomized Open Label Study of Oral ICM20

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications like amiodarone, monoamine oxidase inhibitors, phenytoin, phenobarbital, disulfiram, anticoagulants, or products containing alcohol or propylene glycol. If you are on these, you would need to stop them. Otherwise, you can stay on your current medications if they are stable.

What data supports the effectiveness of the drug ICM20 for advanced cancer?

Immune checkpoint inhibitors (ICIs), which are similar to ICM20, have shown effectiveness in treating advanced cancers by improving survival rates, even in patients with poor performance status. They are considered a safe and effective option, with some patients experiencing long-term benefits. ^{1 2 3 4 5}

What is known about the safety of immune checkpoint inhibitors like ICM20 for advanced cancer?

Immune checkpoint inhibitors (ICIs), which include treatments like ICM20, can cause immune-related adverse events (irAEs) that may require careful management to prevent serious complications. These adverse events can affect various organs and may lead to hospital admissions if not properly managed. Improved clinician training and patient education are important to recognize and address these side effects early. ^{6 7 8 9 10}

Eligibility Criteria

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.

Inclusion Criteria

Not pregnant, lactating, or planning to get pregnant

Human immunodeficiency virus negative

My weight is between 125 and 200 pounds.

Exclusion Criteria

I have a blood clotting disorder.

Known hypersensitivity to either study drug or its constituents

I have a weakened immune system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ICM20 alone or in combination with benznidazole in ascending doses

60 days

Regular visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• ICM20

Trial Overview 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.

Participant Groups

Group I: Dose Level 4 Experimental Treatment 2 Interventions

ICM20 and benznidazole ascending dose 4

Group II: Dose Level 3 Experimental Treatment 2 Interventions

ICM20 and benznidazole ascending dose 3

Group III: Dose Level 2 Experimental Treatment 2 Interventions

ICM20 and benznidazole ascending dose 2

Group IV: Dose Level 1 Experimental Treatment 1 Intervention

ICM20

Who Is Running the Clinical Trial?

IC-MedTech Corporation

Lead Sponsor

Trials

2

Recruited

70+

Findings from Research

Patients with advanced non-small cell lung cancer (NSCLC) and impaired performance status (PS ≥2) had a significantly shorter overall survival (4.5 months) compared to those with better PS (14.3 months), indicating limited efficacy of immune checkpoint inhibitors (ICIs) in this group.

Receiving ICIs in the last 30 days of life was linked to decreased hospice referrals and a higher likelihood of in-hospital deaths, suggesting that the use of ICIs near the end of life may negatively impact end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance status and end-of-life care among adults with non-small cell lung cancer receiving immune checkpoint inhibitors. Petrillo, LA., El-Jawahri, A., Nipp, RD., et al.[2021]

In a study of 155 patients with advanced solid tumors, those with a better performance status (ECOG PS 0-1) had a median overall survival (OS) of 9.1 months, compared to only 2.9 months for those with poorer performance status (ECOG PS 2-4), indicating that performance status significantly impacts treatment outcomes with immune checkpoint inhibitors (ICIs).

Despite having a poor performance status, 27.3% of patients in the study were still alive after one year, and the treatment was generally well-tolerated, with 84.6% of patients experiencing no severe toxicities, suggesting that ICIs can be a safe and effective option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitors in patients with solid tumors and poor performance status: A prospective data from the real-world settings. Kapoor, A., Noronha, V., Patil, VM., et al.[2023]

Immune checkpoint inhibitors (ICIs) can significantly improve outcomes for patients with advanced cancers, but they also come with challenges in managing immune-related adverse events (irAEs), which can lead to treatment discontinuation and increased healthcare costs.

Advanced practice providers (APPs) can play a crucial role in enhancing the management of irAEs through improved telephone triage and the establishment of dedicated oncology acute care services, which can help in early recognition and treatment of these adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting the Challenge of Immune-Related Adverse Events With Optimized Telephone Triage and Dedicated Oncology Acute Care. Hoffner, B., Rubin, KM.[2020]

A systematic review of 36 trials involving 15,370 participants found that atezolizumab generally had the best safety profile among immune checkpoint inhibitors (ICIs), while nivolumab was identified as the safest option specifically for lung cancer treatment.

The study highlighted that treatment-related adverse events primarily affected the skin, endocrine, hepatic, and pulmonary systems, with nivolumab showing a narrow toxicity spectrum and mainly causing mild endocrine toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative safety of immune checkpoint inhibitors in cancer: systematic review and network meta-analysis. Xu, C., Chen, YP., Du, XJ., et al.[2022]

Emerging cancer therapies, such as monoclonal antibodies and immune effector cell therapies, can lead to serious adverse effects like cytokine release syndrome, which is the most common toxicity and can necessitate ICU admission.

Management of these toxicities often requires a multidisciplinary approach and may involve supportive care, corticosteroids, and immune suppressants, highlighting the need for standardized treatment protocols to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical Care Management of Toxicities Associated With Targeted Agents and Immunotherapies for Cancer. Gutierrez, C., McEvoy, C., Munshi, L., et al.[2021]

A review of 2217 adverse drug reaction reports related to immune checkpoint inhibitors (ICIs) from 2011 to 2018 revealed that these drugs, particularly nivolumab, are associated with a higher frequency of serious immune-related adverse events, including gastrointestinal and respiratory disorders.

Emerging safety signals, such as ischaemic heart disease and cardiac failure, were identified, indicating the need for further investigation into the long-term safety profile of ICIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of immune checkpoint inhibitors: An analysis of the Italian spontaneous reporting system database. Cutroneo, PM., Isgrò, V., Ientile, V., et al.[2021]

In a study of 105 patients with advanced pan-cancer treated with immune checkpoint inhibitors (ICIs), specific blood parameters such as lower relative lymphocyte count and higher absolute eosinophil count were identified as predictors for the occurrence of immune-related adverse events (irAEs).

Patients experiencing any grade of irAE had significantly better progression-free survival (PFS) and overall survival (OS), suggesting a potential correlation between the occurrence of irAEs and improved clinical outcomes in ICI therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of characteristics and predictive factors of immune checkpoint inhibitor-related adverse events. Bai, R., Chen, N., Chen, X., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

The PRISMA Symposium 1: outcome tool use. Disharmony in European outcomes research for palliative and advanced disease care: too many tools in practice. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Oncological patients in the intensive care unit: prognosis, decision-making, therapies and end-of-life care. [2018]

3. China pubmed.ncbi.nlm.nih.gov

Do immune checkpoint inhibitors need new studies methodology? [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Performance status and end-of-life care among adults with non-small cell lung cancer receiving immune checkpoint inhibitors. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitors in patients with solid tumors and poor performance status: A prospective data from the real-world settings. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Meeting the Challenge of Immune-Related Adverse Events With Optimized Telephone Triage and Dedicated Oncology Acute Care. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Comparative safety of immune checkpoint inhibitors in cancer: systematic review and network meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Critical Care Management of Toxicities Associated With Targeted Agents and Immunotherapies for Cancer. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Safety profile of immune checkpoint inhibitors: An analysis of the Italian spontaneous reporting system database. [2021]

10. China pubmed.ncbi.nlm.nih.gov

Analysis of characteristics and predictive factors of immune checkpoint inhibitor-related adverse events. [2021]