MelanomaPhase 1NCT05264974
Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization
A Phase 1 study testing Autologous total tumor mRNA loaded DOTAP liposome vaccine in people with Melanoma and Soft Tissue Sarcoma, run by University of Florida at 1 site in United States.
Trial summary
The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Melanoma, Soft Tissue Sarcoma
- What is being tested?
- Autologous total tumor mRNA loaded DOTAP liposome vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2026to Jun 2027
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years old
- ECOG performance ≤ 2
- Lab values within the specified ranges:
- Hemoglobin ≥ 8G/DL
- Platelets ≥ 100 thou/cumm
- Absolute Neutrophil Count (ANC) ≥ 1000 thou/cumm
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- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST and ALT ≤ 2.5 x ULN; If confirmed liver metastases: AST and ALT ≤ 5 x ULN
- Creatinine clearance (CrCl) ≥ 15 ml/min (based on modified Cockcroft and Gault formula)
- Must have measurable disease that is amenable to surgical sampling for RNA extraction, amplification, and loading of lipid particles
- Subjects must not have more than one active malignancy at the time of enrollment (subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician and approved by the PI] may be included)
- Written informed consent obtained from the subject.
- Participants of childbearing potential must have a negative serum pregnancy test at screening
- Participants of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least four months after the last dose of study treatment to minimize the risk of pregnancy. Prior to study enrollment, participants of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
- Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for four months following the last dose of study treatment and must agree to not donate sperm during the study treatment period or for four months following the last dose of study treatment.
- Additional eligibility criteria for subjects with melanoma:
- Patients with stage II, stage III, or resected stage IV melanoma who received anti-PD-1-based therapy in the adjuvant or neoadjuvant setting (either monotherapy or combination therapy) and experienced progressive disease (PD) per RECIST 1.1 during treatment or within 6 months of completing the planned course of therapy. This includes patients who:
- Were planned to receive approximately 1 year of anti-PD-1-based therapy in the adjuvant setting but discontinued early due to toxicity and relapsed within 6 months of discontinuation;
- Received neoadjuvant anti-PD-1-based therapy (with or without subsequent surgery), including patients planned to complete approximately 1 year of total perioperative anti-PD-1-based therapy (neoadjuvant ± adjuvant), and experienced PD during therapy or within 6 months of completion or discontinuation;
- Received short-course neoadjuvant anti-PD-1-based therapy (including combination regimens), underwent surgery, were subsequently managed with surveillance (including those achieving pathologic complete response), and experienced relapse within 6 months of completion of neoadjuvant therapy.
- Patients with unresectable or widespread metastatic (stage IV) melanoma who experienced PD per treating physician while receiving anti-PD-1-based therapy (either monotherapy or combination therapy) in any line of treatment.
- Patients with unresectable or widespread metastatic (stage IV) melanoma who:
- Completed a planned course of anti-PD-1-based therapy (monotherapy or combination), including planned treatment durations of approximately 1 year or 2 years, and experienced PD within 6 months of completion; or
- Were planned to receive anti-PD-1-based therapy (for either 1 year or 2 years) but discontinued early due to toxicity and experienced PD within 6 months of discontinuation.
- Both cutaneous and non-cutaneous melanoma subtypes (including uveal, mucosal, and acral lentiginous) are eligible.
- Patients must:
- Have no contraindication to continued immune checkpoint therapy;
- Not have rapidly progressive disease requiring urgent alternative therapy; and
- Have no other viable approved salvage treatment options available, or decline currently approved salvage therapies.
- Additional eligibility criteria for subjects with soft tissue sarcoma:
- Evidence of spindle cell, pleomorphic, round cell, or epithelioid morphology on pathology suggestive of sarcoma as determined by a sarcoma pathologist
- Evidence of progression or resistance to therapy as defined by the treating physician.
- Must have measurable disease per RECIST 1.1
- Original tumor site from soft tissue location i.e. lipomatous tissue, musculature, skin
- Evidence of unresectable stage II disease; stage III or stage IV disease
- Subjects with prior exposure to an immune checkpoint inhibitor (ICI) are eligible for enrollment; however, prior ICI therapy is not required unless receipt of an ICI constitutes part of the FDA-approved standard of care for their disease.
Who cannot join
- Subjects that have an active second malignancy, however, previously treated early stage malignancies with no evidence of disease recurrence after 3 years of follow-up will be allowed
- Subjects with a history of immune-mediated treatment-related adverse reactions leading to discontinuation of prior aPD1 therapy or severe hypersensitivity reaction to any monoclonal antibody or any other baseline risk in the opinion of the investigator that precludes continued use of aPD1 therapy
- Patients with known active and symptomatic brain metastases or leptomeningeal metastases at time of inclusion. Patients with isolated brain lesions that have been treated with stereotactic radiosurgery or surgical resection as part of oligometastatic initial management prior to start of immunotherapy may be eligible as long as they have no new disease and are asymptomatic at time of inclusion.
- If patients develop new brain metastases during the time between tumor sampling and vaccine generation and administration, patients may remain on study as long as they can receive definitive stereotactic radiosurgery or surgery to brain metastases and be able to resume systemic therapy within 6 weeks of discovery of new brain metastases.
- Subjects who received an investigational drug in another clinical trial must wait 28 days or at least 5 half-lives of the study drug, whichever is shorter, prior to enrollment in this study
- Patients must not have required systemic corticosteroids (anything greater than 10mg of prednisone of equivalent, daily) or other immunosuppressive medications within 14 days of the start of trial treatment.
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- Subjects with known active infection or immunosuppressive disease within seven days prior to tissue collection for vaccine creation or within seven days prior to vaccine administration (subjects on prophylactic agents are acceptable)
- Subjects with any known life-threatening illness, medical condition, or organ system dysfunction (aside from their cancer), which in the investigator's opinion, could compromise subject safety
- Subjects with known active hepatitis B virus or untreated hepatitis C virus, and, patients with previous history of hepatitis C who completed treatment for HCV are not excluded as long as they have no detectable viral load.
- Subjects with known human immunodeficiency virus with CD4+T cells ≤ 350 cells/ul, a positive viral load as determined by institutional standard testing, or a known history of AIDS defining opportunistic infection within the last 12 months per subject medical records.
- Known clinically relevant active autoimmune disease that would pose significant risk to the patient's life should a flare ensue. Patients with chronic autoimmune rheumatologic endocrine, or psoriatic skin diseases may still be eligible pending they are not receiving systemic immunosuppression at the time of treatment as previously described and that patients are aware of the increased risk of flare provocation with treatment.
- Symptomatic congestive heart failure (NYHA Class 3 or 4)
- Subjects with unstable angina pectoris
- Known unstable cardiac arrythmias, abnormalities or transmural myocardial infarction within the last 6 months of treatment
- Subjects who are post-splenectomy or otherwise asplenic
- Personal history of anaphylactic reaction to previous vaccination
- Known hypersensitivity to the active substance or to any of the excipients
- Participants of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 months after the last dose of study treatment
- Participants who are confirmed to be pregnant or breastfeeding
- Known history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician
- Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.
- Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Subjects with sarcoma originating from bone or cartilage
- Sarcomatous malignancies lacking metastatic potential i.e. well-differentiated liposarcoma, dermatofibrosarcoma protuberans, desmoid fibromatosis, etc.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.
Read the detailed description
Melanoma is an increasing public health concern in the state of Florida. The advent of immune checkpoint inhibitors (ICI) has revolutionized the treatment of advanced melanoma. Unfortunately, in the adjuvant setting, up to 30% of subjects will have disease recurrence within 1 year of starting ICI therapy. Previous studies have shown that subjects who progress while on adjuvant ICI treatment, or soon after completion, have a more aggressive course of disease that responds poorly to subsequent immunotherapy. One reason for the failure of ICI in the post adjuvant setting is the immune suppressive nature of the tumor microenvironment (TME) and lack of professional APC activation. These APCs remain in an inert state unable to present tumor antigens for immune detection due to lack of innate immune activation and inhibition from myeloid derived suppressor cells (MDSCs). Similarly, outside of rare subtypes, soft tissue sarcomas (STS) are enriched with an immunosuppressive TME leading to resistance to ICI therapy.
We have developed a novel RNA-lipid particle (RNA-LP) vaccine that simultaneously penetrates and reprograms the TME while inducing a tumor specific adaptive T cell response. This vaccine utilizes novel engineering design that layers tumor derived mRNA into a lipid-nanoparticle "onion-like" package along with pp65 full length lysosomal associated membrane protein (LAMP1) mRNA. These RNA-LPs localize to the TME and activate multiple innate pathways thereby activating APCs and suppressing the function of MDSCs. LAMP mRNA is added to improve innate activation as seen in preclinical modeling and to allow for tracking of T cell receptor specific immune response to vaccination. In this study we propose the use of subject derived RNA-LP vaccine in subjects who progress on, or soon after completion of adjuvant ICI. We propose that through re-priming of the antitumor immune response and alteration of the TME we can improve the efficacy of ICI therapy.
If effective, this treatment will revolutionize the management of this aggressive subset of melanoma and STS to improve overall survival. This study will also gather important information into the mechanisms of early ICI resistance, identify novel biomarkers of innate cell resistance and response to treatment, and provides a cutting edge, personalized immunology approach to treatment.
- Conditions
- Melanoma, Soft Tissue Sarcoma
- Being tested
- Autologous total tumor mRNA loaded DOTAP liposome vaccine
- Keywords
- melanoma, immunotherapy, vaccines, RNA-NP, soft tissue sarcoma
- Medical subject headings
- Melanoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous total tumor mRNA loaded DOTAP liposome vaccineBiological
Also called mRNA-NP (nanoparticle) vaccine
All participants will receive three doses of RNA-LP vaccine (1 dose every 2 weeks) intravenously.
The vaccine dose given will be determined by a 3 + 3 design with cohort sizes of 3 participants. Cohorts will be agnostic of disease indication. Participants will be given one of the following vaccine doses:
Dose Level -2: 0.00015625 mg/kg of mRNA encapsulated in 0.00234375 mg/kg lipid particles (LPs) Dose Level -1 (Starting Dose Level): 0.0003125 mg/kg of mRNA encapsulated in 0.0046875 mg/kg LPs Dose Level 0: 0.000625 mg/kg of mRNA encapsulated in 0.009375 mg/kg LPs Dose Level 1: 0.00125 mg/kg mRNA encapsulated in 0.01875 mg/kg LPs Dose Level 2: 0.0025 mg/kg mRNA encapsulated in 0.0375 mg/kg LPs
| Study group | Role | What they receive |
|---|---|---|
| mRNA-nanoparticle (mRNA-NP) vaccine | Experimental | Not described Receives: Biological: Autologous total tumor mRNA loaded DOTAP liposome vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Determine the maximum tolerated dose of RNA-NP vaccine
Measured: 2 months
Feasibility of treatment with RNA-NP vaccine
Determine the feasibility of treatment with RNA-NP vaccine, defined as the percentage of subjects who undergo tumor sampling and vaccine generation who can have sufficient vaccine produced for treatment across the full three dose vaccination series and within a time window of 4 weeks from time of tumor sampling to vaccine delivery for use.
Measured: 4 weeks
Secondary outcomes (2)
Overall response rate
Determine the overall response rate, defined as the percentage of subjects who attain either a complete or partial response by RECIST 1.1 criteria following completion of the three dose vaccination series.
Measured: 4 weeks
Progression-free survival
Determine the the rate of progression free survival (PFS), defined as the time from study enrollment until progression, following resumption of immune checkpoint inhibition following RNA-LP vaccination.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start17 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Why it stopped: seeking additional funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- Leighton Elliott, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264974
- Sponsor's protocol ID
- UF-CUT-001
- Other IDs
- IRB202200462, OCR41806
- Status last verified
- Sep 2026
- First submitted
- 22 Feb 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization
- ClinicalTrials.gov ID
- NCT05264974
- Acronym / sponsor ID
- UF-CUT-001
- Conditions
- Melanoma, Soft Tissue Sarcoma
- Keywords
- melanoma, immunotherapy, vaccines, RNA-NP, soft tissue sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: seeking additional funding
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Mar 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.
The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.
Detailed description
Melanoma is an increasing public health concern in the state of Florida. The advent of immune checkpoint inhibitors (ICI) has revolutionized the treatment of advanced melanoma. Unfortunately, in the adjuvant setting, up to 30% of subjects will have disease recurrence within 1 year of starting ICI therapy. Previous studies have shown that subjects who progress while on adjuvant ICI treatment, or soon after completion, have a more aggressive course of disease that responds poorly to subsequent immunotherapy. One reason for the failure of ICI in the post adjuvant setting is the immune suppressive nature of the tumor microenvironment (TME) and lack of professional APC activation. These APCs remain in an inert state unable to present tumor antigens for immune detection due to lack of innate immune activation and inhibition from myeloid derived suppressor cells (MDSCs). Similarly, outside of rare subtypes, soft tissue sarcomas (STS) are enriched with an immunosuppressive TME leading to resistance to ICI therapy.
We have developed a novel RNA-lipid particle (RNA-LP) vaccine that simultaneously penetrates and reprograms the TME while inducing a tumor specific adaptive T cell response. This vaccine utilizes novel engineering design that layers tumor derived mRNA into a lipid-nanoparticle "onion-like" package along with pp65 full length lysosomal associated membrane protein (LAMP1) mRNA. These RNA-LPs localize to the TME and activate multiple innate pathways thereby activating APCs and suppressing the function of MDSCs. LAMP mRNA is added to improve innate activation as seen in preclinical modeling and to allow for tracking of T cell receptor specific immune response to vaccination. In this study we propose the use of subject derived RNA-LP vaccine in subjects who progress on, or soon after completion of adjuvant ICI. We propose that through re-priming of the antitumor immune response and alteration of the TME we can improve the efficacy of ICI therapy.
If effective, this treatment will revolutionize the management of this aggressive subset of melanoma and STS to improve overall survival. This study will also gather important information into the mechanisms of early ICI resistance, identify novel biomarkers of innate cell resistance and response to treatment, and provides a cutting edge, personalized immunology approach to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRNA-nanoparticle (mRNA-NP) vaccine | Experimental | Biological: Autologous total tumor mRNA loaded DOTAP liposome vaccine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Adults ≥ 18 years old
- ECOG performance ≤ 2
- Lab values within the specified ranges:
- Must have measurable disease that is amenable to surgical sampling for RNA extraction, amplification, and loading of lipid particles
- Subjects must not have more than one active malignancy at the time of enrollment (subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician and approved by the PI] may be included)
Key exclusion criteria (24 listed)
- Subjects that have an active second malignancy, however, previously treated early stage malignancies with no evidence of disease recurrence after 3 years of follow-up will be allowed
- Subjects with a history of immune-mediated treatment-related adverse reactions leading to discontinuation of prior aPD1 therapy or severe hypersensitivity reaction to any monoclonal antibody or any other baseline risk in the opinion of the investigator that precludes continued use of aPD1 therapy
- Patients with known active and symptomatic brain metastases or leptomeningeal metastases at time of inclusion. Patients with isolated brain lesions that have been treated with stereotactic radiosurgery or surgical resection as part of oligometastatic initial management prior to start of immunotherapy may be eligible as long as they have no new disease and are asymptomatic at time of inclusion.
- If patients develop new brain metastases during the time between tumor sampling and vaccine generation and administration, patients may remain on study as long as they can receive definitive stereotactic radiosurgery or surgery to brain metastases and be able to resume systemic therapy within 6 weeks of discovery of new brain metastases.
- Subjects who received an investigational drug in another clinical trial must wait 28 days or at least 5 half-lives of the study drug, whichever is shorter, prior to enrollment in this study
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 |
|---|---|---|
| Autologous total tumor mRNA loaded DOTAP liposome vaccineAlso: mRNA-NP (nanoparticle) vaccineAll participants will receive three doses of RNA-LP vaccine (1 dose every 2 weeks) intravenously. The vaccine dose given will be determined by a 3 + 3 design with cohort sizes of 3 participants. Cohorts will be agnostic of disease indication. Participants will be given one of the following vaccine doses: Dose Level -2: 0.00015625 mg/kg of mRNA encapsulated in 0.00234375 mg/kg lipid particles (LPs) Dose Level -1 (Starting Dose Level): 0.0003125 mg/kg of mRNA encapsulated in 0.0046875 mg/kg LPs Dose Level 0: 0.000625 mg/kg of mRNA encapsulated in 0.009375 mg/kg LPs Dose Level 1: 0.00125 mg/kg mRNA encapsulated in 0.01875 mg/kg LPs Dose Level 2: 0.0025 mg/kg mRNA encapsulated in 0.0375 mg/kg LPs | Biological | mRNA-nanoparticle (mRNA-NP) vaccine |
Primary outcome
Maximum tolerated dose
Time frame: 2 months
Determine the maximum tolerated dose of RNA-NP vaccine
Feasibility of treatment with RNA-NP vaccine
Time frame: 4 weeks
Determine the feasibility of treatment with RNA-NP vaccine, defined as the percentage of subjects who undergo tumor sampling and vaccine generation who can have sufficient vaccine produced for treatment across the full three dose vaccination series and within a time window of 4 weeks from time of tumor sampling to vaccine delivery for use.
2 secondary outcomes
Overall response rate
Time frame: 4 weeks
Progression-free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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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.
Leighton Elliott, MD principal investigator
University of Florida
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 Autologous total tumor mRNA loaded DOTAP liposome vaccine in people with Melanoma and Soft Tissue Sarcoma, run by University of Florida 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 36 inclusion and 24 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: paused, as of the sponsor's last update on 17 Sep 2026. 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?
Results are not available in the source record.
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?
Maximum tolerated dose (time frame: 2 months). The study lists 2 primary outcomes in all. 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 17 Sep 2026.