ITI-3000 for Merkel Cell Carcinoma

Overseen By Elizabeth Walsh

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Immunomic Therapeutics, Inc.

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: AIDS/HIV, CLL-associated MCC, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and immune response to the new treatment, ITI-3000, in individuals with a specific type of skin cancer called Merkel cell carcinoma (MCC) that involves a virus (polyomavirus). The focus is on those who have had this cancer, completed initial treatments like surgery or radiation, and have been free of active disease for at least a year. This trial offers eligible participants the chance to help researchers learn more about this treatment and its potential benefits. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, giving participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on ongoing immunosuppressive therapy, you may not be eligible, except for low-dose topical, nasal, or inhaled steroids.

Is there any evidence suggesting that ITI-3000 is likely to be safe for humans?

Research shows that ITI-3000 is undergoing safety testing in a new study for patients with polyomavirus-positive Merkel cell carcinoma (MCC), a type of skin cancer. Earlier tests indicated that ITI-3000 was generally well-tolerated. Although human trials have limited information on side effects, earlier lab studies were promising. These studies suggested that ITI-3000 can aid the immune system without causing serious problems.

As the current study begins, detailed safety information from humans may not yet be fully available. This phase is crucial for closely monitoring participants' responses to the treatment, allowing for the quick identification and management of any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ITI-3000 is unique because it targets Merkel cell carcinoma (MCC) linked to the polyomavirus, which is a different approach compared to the standard treatments like surgery, radiation, and chemotherapy. Most existing treatments focus on physically removing or destroying cancer cells, while ITI-3000 is designed to enhance the body's immune response specifically against the polyomavirus-positive cancer cells. This immunotherapy approach could potentially offer a more targeted and less invasive treatment option, making researchers hopeful for its effectiveness and safety in treating MCC.

What evidence suggests that ITI-3000 might be an effective treatment for Merkel cell carcinoma?

Research shows that ITI-3000 is under investigation in this trial as a treatment for polyomavirus-positive Merkel cell carcinoma (MCC), a type of skin cancer. Early lab studies found that ITI-3000, a DNA vaccine, boosts the activity of CD4 T cells, which are part of the immune system and help fight cancer. The vaccine targets a specific protein linked to the virus causing MCC, potentially aiding the body in combating this cancer. Initial results suggest it could enhance the immune response against cancer cells. However, more data from human trials is needed to confirm its effectiveness. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

Participant has adequate hepatic function, as evidenced by a total bilirubin ≤ 1.5 times the ULN, aspartate transaminase (AST), and/or alanine transaminase (ALT) ≤ 3 times the ULN.

Evidence of Merkel cell polyomavirus (MCPyV) in the tumor at initial presentation (pre-therapy) can be provided by a positive anti-MCPyV oncoprotein antibody AMERK Test.

Karnofsky performance status (PS) ≥ 70 or ECOG PS 0-1.

Exclusion Criteria

Participant with CLL-associated MCC.

Participant has a significant medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study.

You lost more than 10% of your body weight in the last month without any apparent reason.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 4 mg dose of the DNA vaccine ITI-3000

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and immunologic response to the ITI-3000 vaccine

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ITI-3000

How Is the Trial Designed?

Group I: Participants With Polyomavirus-Positive Merkel Cell Carcinoma (MCC) Experimental Treatment 1 Intervention

Eight participants with MCC (\> 1.0 years since definitive treatment or participants who had recurrence \>2 years since evidence of disease) and NEAD

Who Is Running the Clinical Trial?

Immunomic Therapeutics, Inc.

Lead Sponsor

Trials

9

Recruited

480+

Published Research Related to This Trial

A retrospective analysis of adverse events related to PD-1/PD-L1 inhibitors revealed a significant association between Pembrolizumab and hepatitis B reactivation (HBVr), with a reporting odds ratio of 2.32, indicating a higher risk compared to other treatments.

No cases of HBVr were reported with Ipilimumab or Avelumab, suggesting that not all immune checkpoint inhibitors carry the same risk, highlighting the need for further prospective studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors. Burns, EA., Muhsen, IN., Anand, K., et al.[2023]

In a study of 92 patients experiencing immune-related adverse events (irAEs) after immune checkpoint inhibitor therapy, 73% showed significant improvement or resolution of their symptoms after treatment with anti-IL-6R antibodies, such as tocilizumab, within a median of 2 months.

The overall tumor response rate remained stable at 66% before and after anti-IL-6R treatment, indicating that this therapy effectively manages irAEs without compromising the effectiveness of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective immune suppression using interleukin-6 receptor inhibitors for management of immune-related adverse events. Fa'ak, F., Buni, M., Falohun, A., et al.[2023]

In a study involving 104 cancer patients treated with immune checkpoint inhibitors, self-reported questionnaires effectively identified over 50% of clinician-reported immune-related adverse events (irAE) related to gastrointestinal, lung, endocrine, and skin issues.

Specific questions about 'weight change' and 'insomnia' were particularly useful in increasing the detection rate of irAE, highlighting the potential for developing a more effective self-reporting tool for monitoring patients undergoing ICI therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors. Griewing, LM., Schweizer, C., Schubert, P., et al.[2023]

In a meta-analysis of 21 studies involving 7108 patients, immune checkpoint inhibitors (ICIs) for digestive system cancers showed a high incidence of treatment-related adverse events (trAEs) at 82.7%, with 27.5% experiencing severe (grade 3 or higher) events.

The analysis revealed that the incidence and characteristics of adverse events varied significantly based on cancer type, treatment modality, and specific ICI agents, highlighting the need for tailored monitoring and intervention strategies to manage these side effects effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of immune checkpoint inhibitors for patients with digestive system cancers: A systematic review and meta-analysis. Kou, L., Wen, Q., Xie, X., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05422781

NCT05422781 | Study To Evaluate The Safety, Tolerability ... Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC).

2. immunomix.com immunomix.com/merkel-cell-carcinoma/

ITI-3000: Merkel Cell Carcinoma Summary: This Phase I clinical trial will evaluate the safety, tolerability, and immunogenicity of 4 mg doses of ITI-3000 in participants with polyomavirus ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05422781?cond=%22Merkel%20Cell%20Carcinoma%22&intr=%22Serine%22&viewType=Table&rank=1

Study To Evaluate The Safety, Tolerability And ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10499392/

LAMP1 targeting of the large T antigen of Merkel cell ... These findings strongly suggest that in pre-clinical studies, DNA vaccination with ITI-3000, using the UNITE™ platform, enhances CD4 T cell ...

5. withpower.com withpower.com/trial/phase-1-carcinoma-5-2022-d1e22

Study To Evaluate The Safety, Tolerability And ... This trial tests a new vaccine called ITI-3000 in patients with a specific type of skin cancer who have finished standard treatments and currently show no ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37711623/

LAMP1 targeting of the large T antigen of Merkel cell ... These findings strongly suggest that in pre-clinical studies, DNA vaccination with ITI-3000, using the UNITE™ platform, enhances CD4 T cell ...