ICM20 for Advanced Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ICM20 for individuals with advanced cancer. It aims to assess the safety and effectiveness of ICM20 at various dose levels, with some groups also receiving benznidazole. Those diagnosed with Chagas disease through positive blood tests and who have not received prior treatment for it might be suitable candidates. Participants must be able to swallow pills and remain stable on their current medications. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatment ICM20 is in the early stages of testing to assess its safety and tolerability. This means it has just begun human trials.

Solid information on its safety is not yet available because the study is ongoing. In this early phase, the main goal is to observe how people respond to the treatment and identify any side effects.

For the combination of ICM20 with benznidazole, earlier studies have shown that benznidazole can cause side effects, but most are mild to moderate. This suggests that the combination might be safe, but more information is needed for confirmation.

Overall, researchers are carefully monitoring these treatments to ensure safety as more participants join the trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ICM20 for advanced cancer because it offers a novel approach by combining it with benznidazole in some doses. Unlike many current treatments that focus on targeting cancer cells directly, ICM20 with benznidazole may enhance the body's immune response against cancer. This combination aims to improve treatment efficacy by potentially reducing resistance to therapy, which is a common challenge with existing options like chemotherapy and targeted therapies. The ascending doses in the trial also allow researchers to determine the optimal balance between effectiveness and safety, which could lead to more personalized treatment strategies for patients with advanced cancer.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

In this trial, participants will receive different treatments involving ICM20, with some groups also receiving benznidazole. Studies have shown that immune checkpoint inhibitors hold promise for people with advanced non-small cell lung cancer (NSCLC), significantly improving survival. Research on benznidazole indicates it can effectively target tumors with low oxygen levels. Combining benznidazole with other treatments has enhanced its effectiveness, even at lower doses. This combination might precisely target hard-to-treat cancer cells. Overall, early evidence suggests these treatments could improve cancer outcomes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

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ICM20 for Advanced Cancer · Info for Participants

Patients with advanced non-small cell lung cancer (NSCLC) and impaired performance status (PS ≥2) had a significantly shorter overall survival (4.5 months) ...

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pmc.ncbi.nlm.nih.gov/articles/PMC9297884/

Long‐term outcomes in patients with advanced and/or ...

Immune checkpoint inhibitors (ICIs) have shown significant improvements in patients with advanced non–small cell lung cancer (NSCLC).

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pmc.ncbi.nlm.nih.gov/articles/PMC9016310/

Real-World Efficacy Data and Predictive Clinical Parameters ...

With a median follow-up duration of 16.0 months, the median progression-free survival (PFS) and overall survival (OS) were 1.9 months (95% confidence interval [ ...

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researchgate.net/publication/393479002_Efficacy_analysis_of_endostar_combined_with_chemoradiotherapy_and_immune_checkpoint_inhibitors_in_locally_advanced_non-small_cell_lung_cancer

(PDF) Efficacy analysis of endostar combined with ...

The effective rates were 12% and 19.2%, and the disease control rates were 88% and 61.5% in groups A and B, respectively. The median progression-free survival ( ...

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This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage ...

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The OPTIMIzE study shows that immunotherapy is effective and tolerable for patients with advanced melanoma in the real-world setting.

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withpower.com/clinical-trials/near-glen-burnie-md?page=4

Top Clinical Trials near Glen Burnie, MD | Power

ICM20 for Advanced Cancer. Glen Burnie, Maryland. A Phase 1 Non-Randomized Open Label Study of Oral ICM20. No Placebo Group. Trial Details. Trial Status:Active ...

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clinicaltrials.gov/study/NCT05651022

NCT05651022 | Study of DECOY20 With or Without ...

A Phase 1/2, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 as monotherapy.