Solid TumorPhase 1NCT01234012
Study of IMF-001 in Patients With Malignancies Expressing NY-ESO-1
A Phase 1 study testing IMF-001 in people with Solid Tumor, run by ImmunoFrontier, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is assess the safety of administering repeated doses of IMF-001, a vaccine, to patients with solid tumors that express NY-ESO-1 antigen. If the vaccine is therapeutically useful, a second goal is to establish the maximum therapeutic dose to treat patients with NY-ESO-1 positive cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- IMF-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to Mar 2014
- 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
- Patients with histologically proven progressive or metastatic solid tumors expressing NY-ESO-1, who have failed standard treatment and have no other effective treatment available (solid tumors such as melanoma, breast cancer, ovarian cancer, prostate cancer, esophageal cancer, uterine cancer, and sarcoma frequently express NY-ESO-1). Patients with malignant melanoma stages IIb and III, or stage IV melanoma that has been completely resected, or with stage I and II uterine serous cancer, clear cell carcinoma, or carcinosarcoma with documented expression of NY-ESO-1 may also enroll as they have a 50% or greater chance of developing recurrent disease.
- Documentation of tumor cells expressing NY-ESO-1 antigen as determined by immunohistochemistry.
- Must have target lesion(s) measurable or non-measurable by RECIST version 1.1. Exceptions: Patients with stages IIb or III melanoma, or stage IV melanoma that has been completely resected, will have no target lesions measurable by RECIST version 1.1 but may enroll; patients with prostate cancer without measurable disease but with rising prostate specific antigen (PSA) levels may enroll; patients with resected stage I and II uterine serous cancer, clear cell carcinoma, and carcinosarcoma will have no target lesions measurable by RECIST but may enroll.
- Has recovered from all acute adverse effects of prior therapy, with the exception of alopecia.
- Laboratory values within the following limits:
- Hemoglobin ≥ 8.0 g/dL
Show all 18Show fewer
- WBC count ≥ 2.0 x 10^9/L
- ANC ≥ 1.0 x 10^9/L
- Platelet count ≥ 75 x 10^9/L
- Serum creatinine ≤ 1.5 mg/dL
- AST \& ALT ≤ 2.5 x ULN (≤ 5 x ULN if with hepatic metastases)
- Serum total bilirubin ≤ 1.5 x ULN
- Performance status of 0 or 1 (ECOG Scale).
- Life expectancy ≥ 4 months.
- Ages 18 years or over.
- Patients with central nervous system metastases may be included if they are treated and stable for 2 months without the need for administration of steroids. Patients with unstable metastatic CNS disease are excluded.
- A negative pregnancy test must be documented at the screening/baseline visit for women of childbearing potential. A female patient of childbearing potential, and a male patient with a female partner of childbearing potential, must be using at least one form of Investigator-approved contraception while on-study and for at least 1 month after their last administration of study therapy.
- Able and willing to give written informed consent.
Who cannot join
- Clinically significant heart disease (NYHA Class III or IV).
- Serious active infection requiring antibiotics.
- Bleeding disorders.
- Unstable metastatic disease in the central nervous system.
- Concomitant systemic treatment with corticosteroids. Topical steroids are permitted.
- History of any severe or life-threatening hypersensitivity or allergic reaction.
Show all 10Show fewer
- Known HIV infection.
- History of immunodeficiency disease or autoimmune disease, including scleroderma, Sjögren's syndrome, lupus erythematosus, idiopathic thrombocytopenic purpura (ITP), multiple sclerosis, or rheumatoid arthritis.
- Has received anticancer chemotherapy, immunotherapy, radiotherapy or any other investigational agent within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment. Concomitant immunosuppressive therapy is not permitted. Adjuvant interferon alpha is not allowed for patients with stages IIb, III or IV melanoma. Prostate cancer patients with PSA only recurrence may have had previous androgen deprivation therapy, provided the 4 week washout period is observed.
- Pregnant or lactating women.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
New York University (NYU) Cancer Center
New York, New York, 10016
About this study
Official title: A Phase I Study of Therapeutic Cancer Vaccine IMF-001 in Patients With Malignancies Expressing NY-ESO-1
The purpose of this study is assess the safety of administering repeated doses of IMF-001, a vaccine, to patients with solid tumors that express NY-ESO-1 antigen. If the vaccine is therapeutically useful, a second goal is to establish the maximum therapeutic dose to treat patients with NY-ESO-1 positive cancers.
Read the detailed description
NY-ESO-1 was isolated by serological analysis of recombinant cDNA expression libraries (SEREX), using tumor mRNA and autologous serum from an esophageal cancer patient. Reverse transcription-polymerase chain reaction (RT-PCR) analysis showed that NY-ESO-1 displayed the typical expression pattern of cancer testis antigens (CT antigens). NY-ESO-1 mRNA was expressed only in testis of normal tissues tested and in various types of cancer, including lung cancer, breast cancer, malignant melanoma and bladder cancer. Since testis is an immune privileged organ where HLA molecules are not expressed, these antigens can be considered tumor-specific.
IMF-001 is a CHP-NY-ESO-1 complex consisting of recombinant NY-ESO-1 protein and cholesteryl hydrophobized pullulan (CHP). CHP forms colloidally stable nanoparticles in water and complexes with substrate such as NY-ESO-1 protein.
It is well known that exogenous antigen proteins can induce specific CD4+ T cells but not specific CD8+ T cell. Dendritic cells pulsed with IMF-001 induced NY-ESO-1 specific CD8+ T cells in blood samples of 4 healthy volunteers. These data suggest that immunization of patients with IMF-001 can evoke not only specific CD4+ T cells responses but also specific CD8+ T cell response to NY-ESO-1 more effectively than NY-ESO-1 protein alone. Similar results for both cellular and humoral immunity in response to NY-ESO-1 protein were observed in previous clinical investigational studies with IMF-001.
- Conditions
- Solid Tumor
- Being tested
- IMF-001
- Keywords
- melanoma, breast cancer, ovarian cancer, prostate cancer, esophageal cancer, uterine cancer, sarcoma, NY-ESO-1
- Medical subject headings
- Melanoma, Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Esophageal Neoplasms, Uterine Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMF-001Biological
subcutaneous injection of fixed dose IMF-001 (100 or 200 mcg) every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: IMF-001 | Experimental | 100 or 200 mcg will be administered to patients subcutaneously every 2 weeks for 6 injections. Receives: Biological: IMF-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events as a measure of safety and tolerability of repeat doses.
Measured: Date of first dose until 30 days after off-study, or until resolution of related AEs
Secondary outcomes (3)
Tumor response using RECIST 1.1
Scans will be performed each cycle after the 4th and 6th injections (approximately Weeks 7 and 11). Scans will be performed; or, for patients with prostate cancer, response will be based on PSA levels.
Measured: Each cycle at weeks 7 and 11 (appx.)
Humoral and cellular immune response as indication of IMF-001 biologic activity
Humoral response (NY-ESO-1 antibody titre) Cellular response (NY-ESO-1 specific CD4 and CD8 T-cells)
Measured: Starting from first dose, samples taken within 72hrs of the 1st, 3rd, and 5th doses of each cycle until off-study
Optimal dose based on number of patients with adverse events at that dose
Measured: Date of first dose until 30 days after off-study, or until resolution of related AEs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startMay 2011
- Primary completionNov 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoFrontier, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DAIJU ICHIMARU, BS, Study director, ImmunoFrontier, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234012
- Sponsor's protocol ID
- IMF001-PRT001
- Status last verified
- Mar 2015
- First submitted
- 26 Oct 2010
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Therapeutic Cancer Vaccine IMF-001 in Patients With Malignancies Expressing NY-ESO-1
- ClinicalTrials.gov ID
- NCT01234012
- Acronym / sponsor ID
- IMF001-PRT001
- Conditions
- Solid Tumor
- Keywords
- melanoma, breast cancer, ovarian cancer, prostate cancer, esophageal cancer, uterine cancer, sarcoma, NY-ESO-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ImmunoFrontier, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Nov 2010 (estimated)
- 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.
The purpose of this study is assess the safety of administering repeated doses of IMF-001, a vaccine, to patients with solid tumors that express NY-ESO-1 antigen. If the vaccine is therapeutically useful, a second goal is to establish the maximum therapeutic dose to treat patients with NY-ESO-1 positive cancers.
Detailed description
NY-ESO-1 was isolated by serological analysis of recombinant cDNA expression libraries (SEREX), using tumor mRNA and autologous serum from an esophageal cancer patient. Reverse transcription-polymerase chain reaction (RT-PCR) analysis showed that NY-ESO-1 displayed the typical expression pattern of cancer testis antigens (CT antigens). NY-ESO-1 mRNA was expressed only in testis of normal tissues tested and in various types of cancer, including lung cancer, breast cancer, malignant melanoma and bladder cancer. Since testis is an immune privileged organ where HLA molecules are not expressed, these antigens can be considered tumor-specific.
IMF-001 is a CHP-NY-ESO-1 complex consisting of recombinant NY-ESO-1 protein and cholesteryl hydrophobized pullulan (CHP). CHP forms colloidally stable nanoparticles in water and complexes with substrate such as NY-ESO-1 protein.
It is well known that exogenous antigen proteins can induce specific CD4+ T cells but not specific CD8+ T cell. Dendritic cells pulsed with IMF-001 induced NY-ESO-1 specific CD8+ T cells in blood samples of 4 healthy volunteers. These data suggest that immunization of patients with IMF-001 can evoke not only specific CD4+ T cells responses but also specific CD8+ T cell response to NY-ESO-1 more effectively than NY-ESO-1 protein alone. Similar results for both cellular and humoral immunity in response to NY-ESO-1 protein were observed in previous clinical investigational studies with IMF-001.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment: IMF-001 | Experimental | Biological: IMF-001100 or 200 mcg will be administered to patients subcutaneously every 2 weeks for 6 injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients with histologically proven progressive or metastatic solid tumors expressing NY-ESO-1, who have failed standard treatment and have no other effective treatment available (solid tumors such as melanoma, breast cancer, ovarian cancer, prostate cancer, esophageal cancer, uterine cancer, and sarcoma frequently express NY-ESO-1). Patients with malignant melanoma stages IIb and III, or stage IV melanoma that has been completely resected, or with stage I and II uterine serous cancer, clear cell carcinoma, or carcinosarcoma with documented expression of NY-ESO-1 may also enroll as they have a 50% or greater chance of developing recurrent disease.
- Documentation of tumor cells expressing NY-ESO-1 antigen as determined by immunohistochemistry.
- Must have target lesion(s) measurable or non-measurable by RECIST version 1.1. Exceptions: Patients with stages IIb or III melanoma, or stage IV melanoma that has been completely resected, will have no target lesions measurable by RECIST version 1.1 but may enroll; patients with prostate cancer without measurable disease but with rising prostate specific antigen (PSA) levels may enroll; patients with resected stage I and II uterine serous cancer, clear cell carcinoma, and carcinosarcoma will have no target lesions measurable by RECIST but may enroll.
- Has recovered from all acute adverse effects of prior therapy, with the exception of alopecia.
- Laboratory values within the following limits:
Key exclusion criteria (10 listed)
- Clinically significant heart disease (NYHA Class III or IV).
- Serious active infection requiring antibiotics.
- Bleeding disorders.
- Unstable metastatic disease in the central nervous system.
- Concomitant systemic treatment with corticosteroids. Topical steroids are permitted.
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 |
|---|---|---|
| IMF-001subcutaneous injection of fixed dose IMF-001 (100 or 200 mcg) every 2 weeks. | Biological | Treatment: IMF-001 |
Primary outcome
Number of patients with adverse events as a measure of safety and tolerability of repeat doses.
Time frame: Date of first dose until 30 days after off-study, or until resolution of related AEs
3 secondary outcomes
Tumor response using RECIST 1.1
Time frame: Each cycle at weeks 7 and 11 (appx.)
Humoral and cellular immune response as indication of IMF-001 biologic activity
Time frame: Starting from first dose, samples taken within 72hrs of the 1st, 3rd, and 5th doses of each cycle until off-study
Optimal dose based on number of patients with adverse events at that dose
Time frame: Date of first dose until 30 days after off-study, or until resolution of related AEs
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 10 Mar 2015.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
DAIJU ICHIMARU, BS study director
ImmunoFrontier, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMF-001 in people with Solid Tumor, run by ImmunoFrontier, Inc. at 2 sites 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 18 inclusion and 10 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 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 patients with adverse events as a measure of safety and tolerability of repeat doses. (time frame: Date of first dose until 30 days after off-study, or until resolution of related AEs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2015.