Colorectal CancerPhase 1NCT06910657
IDOV-Immune for Advanced Solid Tumors
A Phase 1 study testing IDOV-Immune (oncolytic vaccinia virus) in people with Colorectal Cancer and Pancreatic Cancer, run by ViroMissile, Inc. at 5 sites in 2 countries.
Trial summary
This is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Pancreatic Cancer, Melanoma
- What is being tested?
- IDOV-Immune (oncolytic vaccinia virus)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 25 Aug 2025to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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.
- Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exists.
- ECOG performance status ≤ 1.
- Measurable disease per RECIST v1.1.
- Adequate organ and bone marrow function.
- At least 28 days since major surgery, prior immunotherapy, or radiotherapy (with exceptions for minor procedures).
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- Negative pregnancy test for women of childbearing potential.
- Agreement to use effective contraception during treatment and for 3 months after.
- Ability to provide informed consent and comply with study requirements.
Who cannot join
- Prior treatment with an oncolytic virus.
- Active or recent vaccinia virus infection or smallpox/monkeypox vaccination within 10 years.
- Active uncontrolled infection requiring systemic treatment.
- History of hepatitis B, hepatitis C, or HIV (unless meeting protocol-specific criteria).
- Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions).
- Active or symptomatic autoimmune disease requiring systemic therapy.
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- Active or untreated CNS metastases (unless stable per protocol).
- Significant cardiac disease (e.g., NYHA Class III/IV heart failure).
- Interstitial lung disease or prior pneumonitis requiring steroids.
- Conditions requiring chronic immunosuppressive therapy.
- Severe skin disorders or history of pancreatitis.
- Bleeding disorders or history of recent serious thromboembolic events.
- Any medical or psychiatric condition that could interfere with study participation.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Investigator, 877-632-6789 ext. option 1, physicianreferrals@mdanderson.org
- Recruiting
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Investigator, 210-593-5250, information@startresearch.com
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Sara Mitchum, 314-273-8602, saram@wustl.edu
Australia2 sites, 2 recruiting
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Malaka Ameratunga, MD, PhD, +61 03 9076 3129, m.ameratunga@alfred.org.au
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Investigator, +61 2 8890 9945, WSLHD-clinicalresearchsupportunit@health.nsw.gov.au
About this study
Official title: A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors
This is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight the tumor.
The purpose of this study is to determine the safety of IDOV-Immune, how well it is tolerated, and to identify the highest dose that can be safely given. Researchers will also study how the drug behaves in the body, how the immune system responds to it, and whether it shows any signs of shrinking tumors.
Read more
Participants will receive a single intravenous (IV) infusion of IDOV-Immune and will be closely monitored for side effects and any changes in their cancer.
This study is being conducted at multiple sites in the United States and Australia.
Read the detailed description
This is a first-in-human (FIH), Phase I, open-label, multi-center clinical trial designed to evaluate IDOV-Immune, an investigational oncolytic vaccinia virus-based immunotherapy, in adult participants with advanced solid tumors who have exhausted standard treatment options.
IDOV-Immune is a genetically engineered vaccinia virus designed to selectively infect and destroy tumor cells while enhancing immune responses through the expression of immune-stimulating molecules. It has been further modified to improve tumor selectivity and minimize the risk of harming healthy cells.
Study Design:
The trial will follow a dose-escalation design to determine the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), and the overall safety and tolerability profile of IDOV-Immune. A Bayesian Optimal Interval (BOIN) design will guide dose-escalation decisions, based on observed dose-limiting toxicities (DLTs) during a 28-day observation period after the initial dose. The study will also assess preliminary signs of antitumor activity at each dose level.
IDOV-Immune will be administered as a single intravenous (IV) infusion on Day 1 of a 28-day treatment cycle. Participants will undergo frequent safety assessments, including physical exams, laboratory tests, imaging studies, and immune response monitoring. Pharmacokinetics (how the virus behaves in the body), pharmacodynamics (how the virus impacts immune and tumor-related biomarkers), and immunogenicity (the body's immune response to the virus) will also be evaluated.
Planned Enrollment and Cohorts:
The study is expected to enroll up to approximately 42 participants in the dose-escalation phase. If appropriate, additional participants may be enrolled in backfill cohorts at selected dose levels to further assess the safety, biomarkers , and preliminary efficacy in specific populations. Across all study parts, total enrollment could reach approximately 78 participants.
Study Objectives:
The primary objective is to assess the safety and tolerability of IDOV-Immune and to determine the RP2D for future studies. Secondary objectives include evaluating how the investigational product moves through and affects the body (pharmacokinetics and pharmacodynamics), as well as initial signs of tumor response, including objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS).
Rationale:
There remains a significant unmet need for effective therapies for patients with advanced solid tumors who have progressed on or are intolerant to standard treatments. Oncolytic viruses have the potential for destroying cancer cells and activating anti-tumor immune responses. IDOV-Immune's multi-pronged design - combining direct oncolysis, immune recruitment, and immune system activation - aims to maximize therapeutic potential while maintaining an acceptable safety profile.
Study Locations:
The study will be conducted at multiple clinical sites in the United States and Australia with expertise in early-phase oncology trials and oncolytic virus therapies.
- Conditions
- Colorectal Cancer, Pancreatic Cancer, Melanoma, Ovarian Cancer, Gastric Cancer, Esophageal Cancer
- Being tested
- IDOV-Immune (oncolytic vaccinia virus)
- Keywords
- Oncolytic Virus Therapy, Advanced Solid Tumors, Metastatic Cancer, Refractory Cancer, Immunotherapy, Vaccinia Virus
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Melanoma, Ovarian Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDOV-Immune (oncolytic vaccinia virus)Biological
IDOV-Immune is a genetically engineered oncolytic vaccinia virus designed to selectively infect and destroy tumor cells while stimulating the immune system. This study investigates IDOV-Immune as a single intravenous infusion in a first-in-human, Phase 1, dose-escalation trial in participants with advanced solid tumors. The dose will escalate based on safety data, with a goal of identifying the recommended Phase 2 dose (RP2D).
| Study group | Role | What they receive |
|---|---|---|
| IDOV-Immune Dose Escalation Arm | Experimental | Participants in this arm will receive a single intravenous (IV) infusion of IDOV-Immune, an investigational oncolytic vaccinia virus, on Day 1 of a 28-day treatment cycle. The study will follow a dose-escalation design, with each successive cohort receiving an increased dose based on safety data and observed dose-limiting toxicities (DLTs). Following dose escalation, expansion cohorts may be enrolled at selected dose levels to further assess safety and preliminary antitumor activity. Receives: Biological: IDOV-Immune (oncolytic vaccinia virus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
The number and proportion of participants experiencing dose-limiting toxicities (DLTs), assessed by dose level during the DLT evaluation period. DLTs are defined per protocol-specified criteria and graded according to CTCAE.
Measured: From first dose through the end of the DLT evaluation period (28 days)
Safety and Tolerability of IDOV-Immune by Dose Level
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) by dose level.
Measured: From first dose through end of treatment (28 days) (and/or safety follow-up period as defined in protocol [90 days])
Determination of the Maximum Tolerated Dose (MTD)
Dose level(s) at which the observed incidence of dose-limiting toxicities meets protocol-defined criteria for maximum tolerated dose determination.
Measured: From first dose through completion of dose-escalation cohorts (2 years)
Identification of Dose Level(s) for Further Clinical Evaluation
Dose level(s) selected for further clinical evaluation based on integrated safety, tolerability, and pharmacokinetic data, as defined in the protocol.
Measured: From first dose through completion of dose-escalation and data review (2 years)
Secondary outcomes (8)
Pharmacokinetic Parameters of IDOV-Immune by Dose Level
Pharmacokinetic parameters including, but not limited to, maximum observed concentration (Cmax), area under the concentration-time curve (AUC), time to maximum concentration (Tmax), and half-life (t½), summarized by dose level.
Measured: From first dose through completion of PK sampling (2 years)
Pharmacodynamic and Biomarker Responses Following IDOV-Immune Administration
Changes in protocol-specified pharmacodynamic and exploratory biomarker endpoints over time, summarized by dose level.
Measured: From first dose through completion of biomarker assessments (2 years)
Objective Response Rate (ORR)
Percentage of participants with a best overall response of complete response (CR) or partial response (PR), assessed per RECIST v1.1.
Measured: Up to 12 months
Duration of Response (DOR)
Time from first documented objective response (CR or PR) to progression or death.
Measured: Up to 12 months
Disease Control Rate (DCR)
Proportion of participants achieving CR, PR, or stable disease (SD) lasting at least 8 weeks.
Measured: Up to 12 months
Progression-Free Survival (PFS)
Time from first dose to documented disease progression or death from any cause.
Measured: Up to 12 months
Overall Survival (OS)
Time from first dose to death from any cause.
Measured: Up to 12 months
Incidence of Neutralizing Antibody Response
Number of participants who develop detectable anti-vaccinia neutralizing antibodies after IDOV-Immune infusion.
Measured: Up to 90 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start25 Aug 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Sequential
- Model description
- This is a Phase I, open-label, single-group, dose-escalation study evaluating IDOV-Immune, an investigational oncolytic vaccinia virus, in adults with advanced solid tumors. Participants will receive a single intravenous (IV) infusion, with dose levels adjusted based on safety data using a Bayesian Optimal Interval (BOIN) design. The primary goal is to assess safety, tolerability, and determine the recommended Phase 2 dose (RP2D). Dose-limiting toxicities (DLTs) will be monitored for 28 days after dosing. Following dose escalation, expansion cohorts may be opened at selected doses to further evaluate safety and preliminary antitumor activity.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViroMissile, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910657
- Sponsor's protocol ID
- VM-002-101
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06910657
- Acronym / sponsor ID
- VM-002-101
- Conditions
- Colorectal Cancer, Pancreatic Cancer, Melanoma, Ovarian Cancer, Gastric Cancer, Esophageal Cancer
- Keywords
- Oncolytic Virus Therapy, Advanced Solid Tumors, Metastatic Cancer, Refractory Cancer, Immunotherapy, Vaccinia Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- ViroMissile, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 4 Apr 2025 (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 is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight the tumor.
The purpose of this study is to determine the safety of IDOV-Immune, how well it is tolerated, and to identify the highest dose that can be safely given. Researchers will also study how the drug behaves in the body, how the immune system responds to it, and whether it shows any signs of shrinking tumors.
Participants will receive a single intravenous (IV) infusion of IDOV-Immune and will be closely monitored for side effects and any changes in their cancer.
This study is being conducted at multiple sites in the United States and Australia.
Detailed description
This is a first-in-human (FIH), Phase I, open-label, multi-center clinical trial designed to evaluate IDOV-Immune, an investigational oncolytic vaccinia virus-based immunotherapy, in adult participants with advanced solid tumors who have exhausted standard treatment options.
IDOV-Immune is a genetically engineered vaccinia virus designed to selectively infect and destroy tumor cells while enhancing immune responses through the expression of immune-stimulating molecules. It has been further modified to improve tumor selectivity and minimize the risk of harming healthy cells.
Study Design:
The trial will follow a dose-escalation design to determine the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), and the overall safety and tolerability profile of IDOV-Immune. A Bayesian Optimal Interval (BOIN) design will guide dose-escalation decisions, based on observed dose-limiting toxicities (DLTs) during a 28-day observation period after the initial dose. The study will also assess preliminary signs of antitumor activity at each dose level.
IDOV-Immune will be administered as a single intravenous (IV) infusion on Day 1 of a 28-day treatment cycle. Participants will undergo frequent safety assessments, including physical exams, laboratory tests, imaging studies, and immune response monitoring. Pharmacokinetics (how the virus behaves in the body), pharmacodynamics (how the virus impacts immune and tumor-related biomarkers), and immunogenicity (the body's immune response to the virus) will also be evaluated.
Planned Enrollment and Cohorts:
The study is expected to enroll up to approximately 42 participants in the dose-escalation phase. If appropriate, additional participants may be enrolled in backfill cohorts at selected dose levels to further assess the safety, biomarkers , and preliminary efficacy in specific populations. Across all study parts, total enrollment could reach approximately 78 participants.
Study Objectives:
The primary objective is to assess the safety and tolerability of IDOV-Immune and to determine the RP2D for future studies. Secondary objectives include evaluating how the investigational product moves through and affects the body (pharmacokinetics and pharmacodynamics), as well as initial signs of tumor response, including objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS).
Rationale:
There remains a significant unmet need for effective therapies for patients with advanced solid tumors who have progressed on or are intolerant to standard treatments. Oncolytic viruses have the potential for destroying cancer cells and activating anti-tumor immune responses. IDOV-Immune's multi-pronged design - combining direct oncolysis, immune recruitment, and immune system activation - aims to maximize therapeutic potential while maintaining an acceptable safety profile.
Study Locations:
The study will be conducted at multiple clinical sites in the United States and Australia with expertise in early-phase oncology trials and oncolytic virus therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Phase I, open-label, single-group, dose-escalation study evaluating IDOV-Immune, an investigational oncolytic vaccinia virus, in adults with advanced solid tumors. Participants will receive a single intravenous (IV) infusion, with dose levels adjusted based on safety data using a Bayesian Optimal Interval (BOIN) design. The primary goal is to assess safety, tolerability, and determine the recommended Phase 2 dose (RP2D). Dose-limiting toxicities (DLTs) will be monitored for 28 days after dosing. Following dose escalation, expansion cohorts may be opened at selected doses to further evaluate safety and preliminary antitumor activity.
| Arm | Type | Receives |
|---|---|---|
| IDOV-Immune Dose Escalation Arm | Experimental | Biological: IDOV-Immune (oncolytic vaccinia virus)Participants in this arm will receive a single intravenous (IV) infusion of IDOV-Immune, an investigational oncolytic vaccinia virus, on Day 1 of a 28-day treatment cycle. The study will follow a dose-escalation design, with each successive cohort receiving an increased dose based on safety data and observed dose-limiting toxicities (DLTs). Following dose escalation, expansion cohorts may be enrolled at selected dose levels to further assess safety and preliminary antitumor activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exists.
- ECOG performance status ≤ 1.
- Measurable disease per RECIST v1.1.
- Adequate organ and bone marrow function.
Key exclusion criteria (13 listed)
- Prior treatment with an oncolytic virus.
- Active or recent vaccinia virus infection or smallpox/monkeypox vaccination within 10 years.
- Active uncontrolled infection requiring systemic treatment.
- History of hepatitis B, hepatitis C, or HIV (unless meeting protocol-specific criteria).
- Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions).
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 |
|---|---|---|
| IDOV-Immune (oncolytic vaccinia virus)IDOV-Immune is a genetically engineered oncolytic vaccinia virus designed to selectively infect and destroy tumor cells while stimulating the immune system. This study investigates IDOV-Immune as a single intravenous infusion in a first-in-human, Phase 1, dose-escalation trial in participants with advanced solid tumors. The dose will escalate based on safety data, with a goal of identifying the recommended Phase 2 dose (RP2D). | Biological | IDOV-Immune Dose Escalation Arm |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: From first dose through the end of the DLT evaluation period (28 days)
The number and proportion of participants experiencing dose-limiting toxicities (DLTs), assessed by dose level during the DLT evaluation period. DLTs are defined per protocol-specified criteria and graded according to CTCAE.
Safety and Tolerability of IDOV-Immune by Dose Level
Time frame: From first dose through end of treatment (28 days) (and/or safety follow-up period as defined in protocol [90 days])
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) by dose level.
Determination of the Maximum Tolerated Dose (MTD)
Time frame: From first dose through completion of dose-escalation cohorts (2 years)
Dose level(s) at which the observed incidence of dose-limiting toxicities meets protocol-defined criteria for maximum tolerated dose determination.
Identification of Dose Level(s) for Further Clinical Evaluation
Time frame: From first dose through completion of dose-escalation and data review (2 years)
Dose level(s) selected for further clinical evaluation based on integrated safety, tolerability, and pharmacokinetic data, as defined in the protocol.
8 secondary outcomes
Pharmacokinetic Parameters of IDOV-Immune by Dose Level
Time frame: From first dose through completion of PK sampling (2 years)
Pharmacodynamic and Biomarker Responses Following IDOV-Immune Administration
Time frame: From first dose through completion of biomarker assessments (2 years)
Objective Response Rate (ORR)
Time frame: Up to 12 months
Duration of Response (DOR)
Time frame: Up to 12 months
Disease Control Rate (DCR)
Time frame: Up to 12 months
Progression-Free Survival (PFS)
Time frame: Up to 12 months
Overall Survival (OS)
Time frame: Up to 12 months
Incidence of Neutralizing Antibody Response
Time frame: Up to 90 days post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDOV-Immune (oncolytic vaccinia virus) in people with Colorectal Cancer and Pancreatic Cancer, run by ViroMissile, Inc. at 5 sites in 2 countries.
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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Development (858-886-7718, clinicaltrials@viromissile.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: From first dose through the end of the DLT evaluation period (28 days)). The study lists 4 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 5 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.