Glioma, MalignantPhase 1ETAPA INCT05283109
ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM
A Phase 1 study testing Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine and Hiltonol in people with Glioma, Malignant, run by Mustafa Khasraw, MBChB, MD, FRCP, FRACP at 1 site in United States.
Trial summary
This is a phase 1b study of P30-linked EphA2, CMV pp65, and survivin vaccination (collectively called the P30-EPS vaccine) in HLA-A*0201 positive patients with a newly diagnosed, unmethylated, and untreated World Health Organization (WHO) grade IV malignant glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Malignant
- What is being tested?
- Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine and Hiltonol
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 28 Feb 2028
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years of age
- Newly diagnosed Isocitrate dehydrogenase (IDH) wild type (CARIS result), MGMT promoter unmethylated (CARIS result) WHO grade IV glioma (e.g., glioblastoma (GBM) or high grade glioma with molecular features of GBM) with definitive resection prior to enrollment, and residual radiographic contrast enhancement on immediate post-surgical computed tomography (CT), or magnetic resonance imaging (MRI).
- CMV positive or negative by IgG testing.
- Karnofsky Performance Status (KPS) of > 70%.
- Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,000 cells/µl, platelets ≥ 100,000 cells/µl.
- Serum creatinine ≤ 3 x the upper limit of normal (ULN), serum glutamic oxaloacetic transaminase (SGOT)≤ 3 times ULN
Show all 10Show fewer
- Bilirubin ≤ 1.5 times ULN (Exception: Patient has known Gilbert's Syndrome or patient has suspected Gilbert's Syndrome, for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)
- Signed informed consent approved by the Institutional Review Board.
- Female patients must not be pregnant or breast-feeding. Female patients of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, [i.e. with a failure rate of < 1% per year] are implants, injectables, combined oral contraceptives, intra-uterine device [IUD; only hormonal], sexual abstinence or vasectomized partner) during the trial and for a period of > 6 months following the last administration of trial drug(s). Female patients with an intact uterus (unless amenorrhea for the last 24 months) must have a negative serum pregnancy test within 48 hours prior to first vaccination.
- Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control [i.e. with a failure rate of < 1% per year] include a female partner using implants, injectables, combined oral contraceptives, IUDs [only hormonal], sexual abstinence or prior vasectomy) during the trial and for a period of > 6 months following the last administration of trial drug(s).
Who cannot join
- Patients with known potentially anaphylactic allergic reactions to gadolinium-diethylenetriaminepentaacetic acid (DTPA), or any component of the tetanus-diphtheria vaccine.
- Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, radiological evidence of multifocal disease, or leptomeningeal disease.
- Areas of high-grade glioma outside the original radiation field on the post XRT/TMZ MRI.
- Patients who cannot undergo MRI.
- Severe, active comorbidity, including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization;
Show all 20Show fewer
- Transmural myocardial infarction within the last 6 months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of first -vaccination;
- Active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5°F/37.5°C)
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy;
- Known hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
- Known immunosuppressive disease or Human Immunodeficiency Virus (HIV) and -Hepatitis C positive status;
- Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy;
- Active connective tissue disorders, such as lupus or scleroderma that, in the opinion of the treating physician, may put the patient at high risk for radiation toxicity.
- Co-medication that may interfere with study results (e.g., immuno-suppressive agents other than corticosteroids).
- Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin. (Treatment with tamoxifen or aromatase inhibitors or other hormonal therapy that may be indicated in prevention of prior cancer disease recurrence, are not considered current active treatment.)
- Patients are not permitted to have had any other conventional therapeutic intervention other than surgery, steroids, and standard of care chemoradiation prior to enrollment.
- Patients who received previous inguinal lymph node dissection or had radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies to treat a CNS tumor will be excluded.
- Current, recent (within 4 weeks of the administration of this study agent), or planned participation in an experimental drug study.
- Known history of autoimmune disease (with the exceptions of medically-controlled hypothyroidism and Diabetes Mellitus).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Preston Robert Tisch Brain Tumor Center at Duke University
Durham, North Carolina, 27710
About this study
Official title: ETAPA I: Evaluation of Tumor Associated P30-Peptide Antigen I; A Pilot Trial of Peptide-based Tumor Associated Antigen Vaccines in Newly Diagnosed, Unmethylated, and Untreated Glioblastoma (GBM)
This is a phase 1b study of P30-linked EphA2, CMV pp65, and survivin vaccination (collectively called the P30-EPS vaccine) in HLA-A*0201 positive patients with a newly diagnosed, unmethylated, and untreated World Health Organization (WHO) grade IV malignant glioma.
Read the detailed description
This is a phase 1b study of P30-linked EphA2, CMV pp65, and survivin vaccination (collectively called the P30-EPS vaccine) in HLA-A*0201 positive patients with a newly diagnosed, unmethylated, and untreated World Health Organization (WHO) grade IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke, is planned to address the following primary objective: Evaluate the safety profile of a cancer vaccine comprised of P30-linked EphA2, CMV pp65, and survivin peptides.
A maximum of 36 patients with a newly diagnosed, previously untreated WHO grade IV malignant glioma that is MGMT promoter unmethylated will be treated in this study after undergoing standard of care surgical resection followed by 6 weeks of radiation therapy (XRT) with concomitant temozolomide (TMZ) and providing informed consent. Patients will receive seven P30 linked-EphA2, -CMV pp65, and -survivin (P30-EPS) peptide vaccines over two phases. The first 5 will be given during the Priming Phase (day 1 through day 22). The final 2 will be given during the Booster Phase (day 84 [± 2 days] and day 140 [± 2 days]). During the Booster Phase on Day 84, patients will also be given 20ug/kg Hiltonol® injections to administer at home every 2 weeks until they return on Day 140. Blood will be drawn throughout the study to investigate the immune response to P30-EPS vaccination. The study will enroll two patient strata: patients who are CMV seronegative and patients who are CMV seropositive. Within each stratum, cohorts of 3 patients will initially be accrued to the study to assess the toxicity associated with the vaccine. The starting dose of P30-EPS is 300 μg/peptide/dose, and the dose will be escalated to 400 μg/peptide/dose. In the event of unacceptable dose-limiting toxicity, the dose will be de-escalated to 200 μg/peptide/dose (dose level minus one). Acute toxicity monitoring will focus on dose-limiting toxicities, as defined in Section 9.1.2 of the protocol, occurring between vaccine 1 and 30 days after vaccine 5. The most common side effects of peptide vaccines are redness or swelling at the injection site, local changes to the texture of your skin (hardening) at the injection site, itching, allergic reactions, and a potentially serious side effect called cytokine release syndrome. The most common side effects of Hiltonol® are reactions at the injection site and flu-like symptoms.
- Conditions
- Glioma, Malignant
- Being tested
- Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine, Hiltonol
- Keywords
- ETAPA, Pro00102818, Khasraw, Glioblastoma, Glioma, Duke, Vaccine
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Associated Antigen Peptide Vaccine P30-EPS VaccineBiological
Also called P30-EPS
Vaccine that includes 3 peptides (EphA2 linked to P30 peptide, pp65 linked to P30 peptide, and Survivin linked to P30 peptide)
HiltonolDrug
Also called poly-ICLC
Hiltonol® is made up of synthetic (manmade) RNA (ribonucleic acid) and is used as an adjuvant to the vaccine, meaning it is used with the vaccine to stimulate or enhance the activation of your immune system.
| Study group | Role | What they receive |
|---|---|---|
| Tumor Associated Antigen Peptide Vaccine in Combination with Hiltonol | Experimental | The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. Receives: Biological: Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine; Drug: Hiltonol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
A dose-limiting toxicity (DLT) is as an unacceptable toxicity, based on CTCAE v5.0, that occurs during the DLT observation period that extends between date of vaccine #1 (Day 1) and 30 days after vaccine #5 (Day 22). Any ≥ Grade 3 AEs were to be considered as unacceptable toxicities if they were possibly, probably, or definitely attributable to the protocol treatment regimen, and if they occurred within 30 days of vaccination. Specifically, any ≥ Grade 3 organ toxicity (cardiac, renal, hepatic), including CRS-related toxicities such as hypotension and tachycardia, of any duration was to be considered an unacceptable toxicity. A Grade 3 neurologic toxicity was only to be declared an unacceptable toxicity if not reversible within 48 hours. Grade 3 flu-like symptoms, fever, and chills/rigors were not considered unacceptable if the duration was less than 72 hours.
Measured: Approximately 2 months after initiation of P30-EPS study vaccine
Secondary outcomes (6)
Change in Mean Fold Increase in pp56-specific T Cells; Time Frame: Day 1, 22, 84
Stratified between CMV seropositive and seronegative patients
Measured: 3 months
Change in Mean Fold Increase in EphA2- or Survivin- Specific T Cells; Time Frame: Days 1, 22, 84
Amongst all patients
Measured: 3 Months
Change in Mean Fold Increase in pp56-specific T Cells; Time Frame: Day 1, 22, 84
Stratified between CMV seropositive and seronegative patients
Measured: 5 months
Change in Mean Fold Increase in EphA2- or Survivin- Specific T Cells; Time Frame: Days 1, 22, 84
Amongst all patients
Measured: 5 months
Median Survival
Amongst all patients
Measured: 36 months
Median Progression-free Survival
Amongst all patients
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start30 Aug 2023
- Primary completion11 Apr 2025
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glioma, MalignantStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Khasraw, MBChB, MD, FRCP, FRACP
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Mustafa Khasraw, MBChB, MD, FRCP, FRACP, Duke University
- Investigators
- Mustafa Khasraw, MBChB, MD, FRCP, FRACP, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283109
- Sponsor's protocol ID
- Pro00102818
- Other IDs
- 5P50CA190991
- Acronym
- ETAPA I
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2022
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ETAPA I: Evaluation of Tumor Associated P30-Peptide Antigen I; A Pilot Trial of Peptide-based Tumor Associated Antigen Vaccines in Newly Diagnosed, Unmethylated, and Untreated Glioblastoma (GBM)
- ClinicalTrials.gov ID
- NCT05283109
- Acronym / sponsor ID
- ETAPA I / Pro00102818
- Conditions
- Glioma, Malignant
- Keywords
- ETAPA, Pro00102818, Khasraw, Glioblastoma, Glioma, Duke, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mustafa Khasraw, MBChB, MD, FRCP, FRACPUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Posted 30 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1b study of P30-linked EphA2, CMV pp65, and survivin vaccination (collectively called the P30-EPS vaccine) in HLA-A*0201 positive patients with a newly diagnosed, unmethylated, and untreated World Health Organization (WHO) grade IV malignant glioma.
Detailed description
This is a phase 1b study of P30-linked EphA2, CMV pp65, and survivin vaccination (collectively called the P30-EPS vaccine) in HLA-A*0201 positive patients with a newly diagnosed, unmethylated, and untreated World Health Organization (WHO) grade IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke, is planned to address the following primary objective: Evaluate the safety profile of a cancer vaccine comprised of P30-linked EphA2, CMV pp65, and survivin peptides.
A maximum of 36 patients with a newly diagnosed, previously untreated WHO grade IV malignant glioma that is MGMT promoter unmethylated will be treated in this study after undergoing standard of care surgical resection followed by 6 weeks of radiation therapy (XRT) with concomitant temozolomide (TMZ) and providing informed consent. Patients will receive seven P30 linked-EphA2, -CMV pp65, and -survivin (P30-EPS) peptide vaccines over two phases. The first 5 will be given during the Priming Phase (day 1 through day 22). The final 2 will be given during the Booster Phase (day 84 [± 2 days] and day 140 [± 2 days]). During the Booster Phase on Day 84, patients will also be given 20ug/kg Hiltonol® injections to administer at home every 2 weeks until they return on Day 140. Blood will be drawn throughout the study to investigate the immune response to P30-EPS vaccination. The study will enroll two patient strata: patients who are CMV seronegative and patients who are CMV seropositive. Within each stratum, cohorts of 3 patients will initially be accrued to the study to assess the toxicity associated with the vaccine. The starting dose of P30-EPS is 300 μg/peptide/dose, and the dose will be escalated to 400 μg/peptide/dose. In the event of unacceptable dose-limiting toxicity, the dose will be de-escalated to 200 μg/peptide/dose (dose level minus one). Acute toxicity monitoring will focus on dose-limiting toxicities, as defined in Section 9.1.2 of the protocol, occurring between vaccine 1 and 30 days after vaccine 5. The most common side effects of peptide vaccines are redness or swelling at the injection site, local changes to the texture of your skin (hardening) at the injection site, itching, allergic reactions, and a potentially serious side effect called cytokine release syndrome. The most common side effects of Hiltonol® are reactions at the injection site and flu-like symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor Associated Antigen Peptide Vaccine in Combination with Hiltonol | Experimental | Biological: Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine, Drug: HiltonolThe study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years of age
- Newly diagnosed Isocitrate dehydrogenase (IDH) wild type (CARIS result), MGMT promoter unmethylated (CARIS result) WHO grade IV glioma (e.g., glioblastoma (GBM) or high grade glioma with molecular features of GBM) with definitive resection prior to enrollment, and residual radiographic contrast enhancement on immediate post-surgical computed tomography (CT), or magnetic resonance imaging (MRI).
- CMV positive or negative by IgG testing.
- Karnofsky Performance Status (KPS) of > 70%.
- Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,000 cells/µl, platelets ≥ 100,000 cells/µl.
Key exclusion criteria (20 listed)
- Patients with known potentially anaphylactic allergic reactions to gadolinium-diethylenetriaminepentaacetic acid (DTPA), or any component of the tetanus-diphtheria vaccine.
- Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, radiological evidence of multifocal disease, or leptomeningeal disease.
- Areas of high-grade glioma outside the original radiation field on the post XRT/TMZ MRI.
- Patients who cannot undergo MRI.
- Severe, active comorbidity, including any of the following:
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 |
|---|---|---|
| Tumor Associated Antigen Peptide Vaccine P30-EPS VaccineAlso: P30-EPSVaccine that includes 3 peptides (EphA2 linked to P30 peptide, pp65 linked to P30 peptide, and Survivin linked to P30 peptide) | Biological | Tumor Associated Antigen Peptide Vaccine in Combination with Hiltonol |
| HiltonolAlso: poly-ICLCHiltonol® is made up of synthetic (manmade) RNA (ribonucleic acid) and is used as an adjuvant to the vaccine, meaning it is used with the vaccine to stimulate or enhance the activation of your immune system. | Drug | Tumor Associated Antigen Peptide Vaccine in Combination with Hiltonol |
Primary outcome
Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
Time frame: Approximately 2 months after initiation of P30-EPS study vaccine
A dose-limiting toxicity (DLT) is as an unacceptable toxicity, based on CTCAE v5.0, that occurs during the DLT observation period that extends between date of vaccine #1 (Day 1) and 30 days after vaccine #5 (Day 22). Any ≥ Grade 3 AEs were to be considered as unacceptable toxicities if they were possibly, probably, or definitely attributable to the protocol treatment regimen, and if they occurred within 30 days of vaccination. Specifically, any ≥ Grade 3 organ toxicity (cardiac, renal, hepatic), including CRS-related toxicities such as hypotension and tachycardia, of any duration was to be considered an unacceptable toxicity. A Grade 3 neurologic toxicity was only to be declared an unacceptable toxicity if not reversible within 48 hours. Grade 3 flu-like symptoms, fever, and chills/rigors were not considered unacceptable if the duration was less than 72 hours.
6 secondary outcomes
Change in Mean Fold Increase in pp56-specific T Cells; Time Frame: Day 1, 22, 84
Time frame: 3 months
Change in Mean Fold Increase in EphA2- or Survivin- Specific T Cells; Time Frame: Days 1, 22, 84
Time frame: 3 Months
Change in Mean Fold Increase in pp56-specific T Cells; Time Frame: Day 1, 22, 84
Time frame: 5 months
Change in Mean Fold Increase in EphA2- or Survivin- Specific T Cells; Time Frame: Days 1, 22, 84
Time frame: 5 months
Median Survival
Time frame: 36 months
Median Progression-free Survival
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Preston Robert Tisch Brain Center at Duke UniversityLink provided by the sponsor.
- Duke HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Glioma, Malignant
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
RecruitingEarly Phase 1
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Diffuse Glioma, Malignant Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Active, not recruitingPhase 1/2
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 2
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
High Grade Glioma, CNS Tumor
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.
Mustafa Khasraw, MBChB, MD, FRCP, FRACP principal investigator
Duke University
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 Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine and Hiltonol in people with Glioma, Malignant, run by Mustafa Khasraw, MBChB, MD, FRCP, FRACP 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 10 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 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?
Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Who Experienced Dose-limiting Toxicity (DLT) (time frame: Approximately 2 months after initiation of P30-EPS study vaccine). 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 30 Apr 2026.