Merkel Cell CarcinomaPhase 1NCT05422781
Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)
A Phase 1 study testing ITI-3000 in people with Merkel Cell Carcinoma, run by Immunomic Therapeutics, Inc. at 1 site in United States.
Trial summary
This Phase I clinical trial will evaluate the safety, tolerability, and immunogenicity of 4 mg doses of ITI-3000 in participants with polyomavirus-positive Merkel cell carcinoma (MCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Merkel Cell Carcinoma
- What is being tested?
- ITI-3000
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2022to 27 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eligible participants have to be both be diagnosed and have completed SOC surgical and/or radiation therapy at least 1 year prior to enrollment in the study and have no evidence of active disease (NEAD).
- Participants who were previously diagnosed with MCC and had recurrence and also exhibited no evidence of active disease (NEAD) for more than 2 years prior to enrollment in the study.
- Age ≥ 18 years.
- Karnofsky performance status (PS) ≥ 70 or ECOG PS 0-1.
- Participant has a predicted life expectancy ≥ 3 months.
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- Participant provided signed and dated informed consent prior to initiation of any study procedures.
- Participant has adequate renal function (creatinine ≤ 1.5 times the upper limit of normal [ULN]) or a glomerular filtration rate (GFR) of ≥ 50 mL/min/1.73 m2).
- 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.
- Participant has adequate bone marrow function, as evidenced by hemoglobin ≥ 9.0 g/dL in the absence of transfusion within the previous 72 hours, platelet count ≥ 100×109cells/L, and absolute neutrophil count (ANC) ≥ 1.5×109 cells/L.
- Participant and his/her partner agree to use adequate contraception after providing written informed consent through 2 months after the last study drug dose, as follows:
- For women: Negative pregnancy test during Screening and at Baseline and compliant with two methods of medically-approved contraceptive regimens or abstinence during and for 2 months after the treatment period or documented to be surgically sterile or postmenopausal.
- For men: Compliant with two methods of medically approved contraceptive regimens or abstinence during and for 2 months after the treatment period or documented to be surgically sterile
- Participant is willing and able to participate in the study and comply with all study requirements.
Who cannot join
- Participation in another therapeutic clinical trial.
- Participant who received systemic treatment previously (e.g., chemotherapy, PD-1/PD-L1).
- Participant is pregnant or breast-feeding.
- Negative for an anti-MCPyV oncogene antibody titer or other evidence of no MCPyV involvement at initial presentation using an acceptable and specific assay at the institution.
- Known history of AIDS/HIV, other viral diseases or oncologic disorders such as untreated HCV, chronic active HBV or organ transplantation that may have immunologic consequences or require immunosuppression. No testing required.
- Participant with CLL-associated MCC.
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- On-going immunosuppressive therapy for other conditions with the exception of low-dose topical, nasal or inhaled steroids.
- Participant has a history of other malignancy treated with curative intent within the previous 3 years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. Participants with previous invasive cancers are eligible if the treatment was completed more than 3 years prior to initiating current study treatment, and there is no evidence of recurrent disease.
- 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.
- Participant with otherwise unexplained >10% weight loss in the last 30 days prior to the screening.
- Participant has evidence of serious active infection (i.e., infection requiring treatment with intravenous antibiotics).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: A Phase I, Open Label, First In Humans (FIH), Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)
This Phase I clinical trial will evaluate the safety, tolerability, and immunogenicity of 4 mg doses of ITI-3000 in participants with polyomavirus-positive Merkel cell carcinoma (MCC).
Read the detailed description
This is a single dose design examining 4 mg dose of the DNA vaccine ITI-3000 in participants who were diagnosed with polyomavirus-positive MCC, histologically confirmed by an expert pathologist on standard clinical staining, that may have been supplemented by specific staining for Cytokeratin 20 (CK20) and/or other markers used to distinguish MCC.
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.
Participants in the study are those who are both diagnosed and have completed standard of care (SOC) surgical and/or radiation therapy at least 1 year prior to enrollment in the study and have no evidence of active disease (NEAD). Participants those who were previously diagnosed with MCC, and had recurrence and also exhibited no evidence of active disease (NEAD) for more than 2 years prior to enrollment in the study.
NEAD is confirmed by physical examination, a negative AMERK test (<74 STU) in participants with a prior positive AMERK test, or significantly decreased, stable AMERK titers in 2 or more consecutive draws compared to prior positive AMERK test at the time of diagnosis, in the setting of a negative computed tomography (CT) scan of the chest, abdomen and pelvis or PET-CT within 3 months of enrollment into the study.
Eight participants will be enrolled at 4 mg total DNA dose to assess safety, tolerability, and immunologic response to the ITI-3000 vaccine.
- Conditions
- Merkel Cell Carcinoma
- Being tested
- ITI-3000
- Medical subject headings
- Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-3000Drug
ITI-3000 is a DNA vaccine (L-H LT S220A) which contains sequences for both LAMP1 and LTS220A, the truncated form of the LT antigen of MCPyV with a detoxifying serine to alanine mutation at position 220
| Study group | Role | What they receive |
|---|---|---|
| Participants With Polyomavirus-Positive Merkel Cell Carcinoma (MCC) | Experimental | Eight participants with MCC (> 1.0 years since definitive treatment or participants who had recurrence >2 years since evidence of disease) and NEAD Receives: Drug: ITI-3000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities (DLTs).
Number of participants that experience any Dose Limiting Toxicities (DLTs).
Measured: Through study completion, up to 12 months.
Number of occurrences of Adverse events/Serious Adverse Events that will be assessed for severity according to the NCI CTCAE, version 5.0.
Number of occurrences of Adverse events/Serious Adverse Events that will be assessed for severity according to the NCI CTCAE, version 5.0.
Measured: Through study completion, up to 12 months.
Number of participants with changes from baseline in physical exam findings.
Number of participants with changes from baseline in physical exam (e.g. weight, height, etc.) findings.
Measured: Through study completion, up to 12 months.
Number of participants with changes from baseline in hematology lab results.
Number of participants with changes from baseline in hematology lab results (e.g. Hgb, PLT CT, Hct, RBC, etc.).
Measured: Through study completion, up to 12 months.
Number of participants with changes from baseline in chemistry lab results.
Number of participants with changes from baseline in chemistry lab results (e.g. Alb, ALK, CO2, BUN, Glu,etc.) .
Measured: Through study completion, up to 12 months.
Number of participants with changes from baseline in urinalysis lab results.
Number of participants with changes from baseline in urinalysis lab results (e.g. SPG, pH, TP, Glu, etc.) .
Measured: Through study completion, up to 12 months.
Number of participants with changes from baseline vital signs.
Number of participants with changes from baseline vital signs (e.g. body temp, BP, RR, etc.) .
Measured: Through study completion, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start13 Jun 2022
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Merkel Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunomic Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422781
- Sponsor's protocol ID
- ITI-3000
- Status last verified
- Nov 2023
- First submitted
- 1 Jun 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buchta Rosean C, Leyder EC, Hamilton J, Carter JJ, Galloway DA, Koelle DM, Nghiem P, Heiland T. LAMP1 targeting of the large T antigen of Merkel cell polyomavirus results in potent CD4 T cell responses and tumor inhibition. Front Immunol. 2023 Aug 30;14:1253568. doi: 10.3389/fimmu.2023.1253568. eCollection 2023.
PubMed 37711623
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, First In Humans (FIH), Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)
- ClinicalTrials.gov ID
- NCT05422781
- Acronym / sponsor ID
- ITI-3000
- Conditions
- Merkel Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Immunomic Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I clinical trial will evaluate the safety, tolerability, and immunogenicity of 4 mg doses of ITI-3000 in participants with polyomavirus-positive Merkel cell carcinoma (MCC).
Detailed description
This is a single dose design examining 4 mg dose of the DNA vaccine ITI-3000 in participants who were diagnosed with polyomavirus-positive MCC, histologically confirmed by an expert pathologist on standard clinical staining, that may have been supplemented by specific staining for Cytokeratin 20 (CK20) and/or other markers used to distinguish MCC.
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.
Participants in the study are those who are both diagnosed and have completed standard of care (SOC) surgical and/or radiation therapy at least 1 year prior to enrollment in the study and have no evidence of active disease (NEAD). Participants those who were previously diagnosed with MCC, and had recurrence and also exhibited no evidence of active disease (NEAD) for more than 2 years prior to enrollment in the study.
NEAD is confirmed by physical examination, a negative AMERK test (<74 STU) in participants with a prior positive AMERK test, or significantly decreased, stable AMERK titers in 2 or more consecutive draws compared to prior positive AMERK test at the time of diagnosis, in the setting of a negative computed tomography (CT) scan of the chest, abdomen and pelvis or PET-CT within 3 months of enrollment into the study.
Eight participants will be enrolled at 4 mg total DNA dose to assess safety, tolerability, and immunologic response to the ITI-3000 vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With Polyomavirus-Positive Merkel Cell Carcinoma (MCC) | Experimental | Drug: ITI-3000Eight participants with MCC (> 1.0 years since definitive treatment or participants who had recurrence >2 years since evidence of disease) and NEAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- Eligible participants have to be both be diagnosed and have completed SOC surgical and/or radiation therapy at least 1 year prior to enrollment in the study and have no evidence of active disease (NEAD).
- Participants who were previously diagnosed with MCC and had recurrence and also exhibited no evidence of active disease (NEAD) for more than 2 years prior to enrollment in the study.
- Age ≥ 18 years.
- Karnofsky performance status (PS) ≥ 70 or ECOG PS 0-1.
Key exclusion criteria (11 listed)
- Participation in another therapeutic clinical trial.
- Participant who received systemic treatment previously (e.g., chemotherapy, PD-1/PD-L1).
- Participant is pregnant or breast-feeding.
- Negative for an anti-MCPyV oncogene antibody titer or other evidence of no MCPyV involvement at initial presentation using an acceptable and specific assay at the institution.
- Known history of AIDS/HIV, other viral diseases or oncologic disorders such as untreated HCV, chronic active HBV or organ transplantation that may have immunologic consequences or require immunosuppression. No testing required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITI-3000ITI-3000 is a DNA vaccine (L-H LT S220A) which contains sequences for both LAMP1 and LTS220A, the truncated form of the LT antigen of MCPyV with a detoxifying serine to alanine mutation at position 220 | Drug | Participants With Polyomavirus-Positive Merkel Cell Carcinoma (MCC) |
Primary outcome
Number of participants with Dose Limiting Toxicities (DLTs).
Time frame: Through study completion, up to 12 months.
Number of participants that experience any Dose Limiting Toxicities (DLTs).
Number of occurrences of Adverse events/Serious Adverse Events that will be assessed for severity according to the NCI CTCAE, version 5.0.
Time frame: Through study completion, up to 12 months.
Number of occurrences of Adverse events/Serious Adverse Events that will be assessed for severity according to the NCI CTCAE, version 5.0.
Number of participants with changes from baseline in physical exam findings.
Time frame: Through study completion, up to 12 months.
Number of participants with changes from baseline in physical exam (e.g. weight, height, etc.) findings.
Number of participants with changes from baseline in hematology lab results.
Time frame: Through study completion, up to 12 months.
Number of participants with changes from baseline in hematology lab results (e.g. Hgb, PLT CT, Hct, RBC, etc.).
Number of participants with changes from baseline in chemistry lab results.
Time frame: Through study completion, up to 12 months.
Number of participants with changes from baseline in chemistry lab results (e.g. Alb, ALK, CO2, BUN, Glu,etc.) .
Number of participants with changes from baseline in urinalysis lab results.
Time frame: Through study completion, up to 12 months.
Number of participants with changes from baseline in urinalysis lab results (e.g. SPG, pH, TP, Glu, etc.) .
Number of participants with changes from baseline vital signs.
Time frame: Through study completion, up to 12 months.
Number of participants with changes from baseline vital signs (e.g. body temp, BP, RR, etc.) .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 37711623Buchta Rosean C, Leyder EC, Hamilton J, Carter JJ, Galloway DA, Koelle DM, Nghiem P, Heiland T. LAMP1 targeting of the large T antigen of Merkel cell polyomavirus results in potent CD4 T cell responses and tumor inhibition. Front Immunol. 2023 Aug 30;14:1253568. doi: 10.3389/fimmu.2023.1253568. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITI-3000 in people with Merkel Cell Carcinoma, run by Immunomic Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities (DLTs). (time frame: Through study completion, up to 12 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05422781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.