Solid TumorPhase 1NCT06364696
A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors
A Phase 1 study testing ASP4396 in people with Solid Tumor, run by Astellas Pharma Inc at 7 sites in United States.
Trial summary
Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. 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?
- ASP4396
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Apr 2024to 18 Jun 2026
- 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
- Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented KRAS G12D mutation and has received prior standard therapy.
- Participant has at least 1 measurable lesion per RECIST v1.1.
- Participant has an ECOG performance status of 0 or 1.
- Participant has adequate organ function.
Who cannot join
- Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with asymptomatic and treated and stable CNS metastases are eligible.
- Participant has leptomeningeal disease as a manifestation of the current malignancy.
- Participant has another prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.
- Participant with active hepatitis B or hepatitis C virus (HCV).
- Participant has a known history of human immunodeficiency virus (HIV) infection with acquired immunodeficiency syndrome (AIDS)-related complications.
- Participant has an active infection requiring intravenous antibiotics within 14 days prior to study intervention.
- Participant is expected to require another form of anticancer therapy while on study intervention.
- Participant has any condition that makes the participant unsuitable for study participation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
NEXT Oncology Virginia
Fairfax, Virginia, 22031
START Midwest
Grand Rapids, Michigan, 49546
NEXT Oncology Dallas
Irving, Texas, 75039
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Rochester
Rochester, New York, 14627
START Mountain Region
West Valley City, Utah, 84119
University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
Official title: An Open-label Phase 1 Study of ASP4396 in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation
Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors.
ASP4396 is being developed as a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene. ASP4396 is not currently available as a treatment for the public. In this study, researchers will learn how ASP4396 is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from ASP4396.
Read more
In this study, ASP4396 is being given to humans for the first time.
People in this study will be adults with locally advanced (unresectable), or metastatic solid tumors with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies or refused to receive those treatments.
The main aims of the study are to check the safety of ASP4396, how well people cope with medical problems during the study (how well it is tolerated), and to find a suitable dose of ASP4396.
This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP4396.
This study will be in 2 parts.
Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of ASP4396. For each dose, all medical problems will be recorded. The first group will receive the lowest dose of ASP4396. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396. The panel will do this until all groups have taken ASP4396 or until suitable doses have been selected for Part 2.
Part 2 is called Dose Expansion. Other different small groups of people will receive ASP4396 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP4396 to use in future studies.
In both parts of the study, ASP4396 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. People will continue treatment until: they have medical problems from the treatment they can't cope with (can't tolerate); their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.
People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. The study doctors will check for any medical problems from ASP4396. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during treatment with the option of a tumor sample being taken after treatment has finished.
People will visit the clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.
After this, people will visit the clinic for a health check several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.
After treatment has finished, people in the study will be followed up for up to 45 weeks.
- Conditions
- Solid Tumor
- Being tested
- ASP4396
- Keywords
- Locally Advanced Solid Tumors, Metastatic Solid Tumors, ASP4396, KRAS G12D, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP4396Drug
Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| ASP4396 Dose Escalation | Experimental | Participants will receive ASP4396 in a 21-day cycle. Receives: Drug: ASP4396 |
| ASP4396 Dose Expansion | Experimental | Participants will receive ASP4396 in a 21-day cycle. Receives: Drug: ASP4396 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs) for ASP4369
A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 at least possibly related to study intervention.
Measured: Up to 21 days
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 12 months
Number of Participants with Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important events.
Measured: Up to 12 months
Number of Participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 12 months
Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Measured: Up to 12 months
Number of Participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 12 months
Number of Participants with physical exam abnormalities and/or AEs
Number of participants with potentially clinically significant physical exam values or symptoms.
Measured: Up to 12 months
Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Measured: Up to 12 months
Secondary outcomes (16)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR is defined as the proportion of participants whose best overall response with confirmation status is rated as (confirmed or unconfirmed) complete response (CR) or (confirmed or unconfirmed) partial response (PR) based on RECIST v1.1.
Measured: Up to 12 months
Duration of Response (DOR) per RECIST v 1.1
DOR is measured from the day the criteria are first met for time point overall response rated as CR or PR (whichever is first recorded) until the first date of documented radiological disease progression per RECIST v1.1 or death in the absence of progression.
Measured: Up to 12 months
Disease Control Rate (DCR) per RECIST v 1.1
DCR is defined as the proportion of participants whose best overall response with confirmation status is rated as (confirmed or unconfirmed) CR, (confirmed or unconfirmed) PR or stable disease (SD) (including non-CR/non-progressive disease [PD] for participants with no measurable disease at baseline) based on RECIST v1.1.
Measured: Up to 12 months
Progression Free Survival (PFS) per RECIST v1.1
PFS is defined as the time from the start of study intervention until the date of documented radiological disease progression per RECIST v1.1 or until death for any cause, whichever comes first.
Measured: Up to 12 months
Overall Survival (OS)
OS is defined as the time from the start of study intervention until death due to any cause.
Measured: Up to 12 months
Pharmacokinetics (PK) of ASP4396 in plasma: area under the concentration-time curve from the time of dosing to 24 hours after dosing (AUC24h)
AUC24h will be recorded from the PK plasma samples collected.
Measured: Up to 12 months
PK of ASP4396 metabolite in plasma: AUC24h
AUC24h will be recorded from the PK plasma samples collected.
Measured: Up to 12 months
PK of ASP4396 in plasma: AUC168h
AUC168h will be recorded from the PK plasma samples collected.
Measured: Up to 12 months
PK of ASP4396 metabolite in plasma: AUC168h
AUC168h will be recorded from the PK plasma samples collected.
Measured: Up to 12 months
PK of ASP4396 in plasma: Maximum Concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to 12 months
PK of ASP4396 metabolite in plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to 12 months
PK of ASP4396 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the PK plasma samples collected.
Measured: Up to 12 months
PK of ASP4396 metabolite in plasma: Ctrough
Ctrough will be recorded from the PK plasma samples collected.
Measured: Up to 12 months
PK of ASP4396 in plasma: Time of maximum concentration (tmax)
tmax will be recorded from the PK plasma samples collected.
Measured: Up to 12 months
PK of ASP4396 metabolite in plasma: tmax
tmax will be recorded from the PK plasma samples collected.
Measured: Up to 12 months
Change from baseline of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D amino acid substitution (G12D) tumor samples
Changes in KRAS G12D in tumor samples will be measured.
Measured: Baseline and up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start16 Apr 2024
- Primary completion18 Jun 2026
- Study completion18 Jun 2026
Why it stopped: Company's strategic decision
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364696
- Sponsor's protocol ID
- 4396-CL-0101
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1 Study of ASP4396 in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation
- ClinicalTrials.gov ID
- NCT06364696
- Acronym / sponsor ID
- 4396-CL-0101
- Conditions
- Solid Tumor
- Keywords
- Locally Advanced Solid Tumors, Metastatic Solid Tumors, ASP4396, KRAS G12D, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company's strategic decision
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 18 Jun 2026 (actual)
- Study completion
- 18 Jun 2026 (actual)
- First posted
- 15 Apr 2024 (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.
Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors.
ASP4396 is being developed as a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene. ASP4396 is not currently available as a treatment for the public. In this study, researchers will learn how ASP4396 is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from ASP4396.
In this study, ASP4396 is being given to humans for the first time.
People in this study will be adults with locally advanced (unresectable), or metastatic solid tumors with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies or refused to receive those treatments.
The main aims of the study are to check the safety of ASP4396, how well people cope with medical problems during the study (how well it is tolerated), and to find a suitable dose of ASP4396.
This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP4396.
This study will be in 2 parts.
Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of ASP4396. For each dose, all medical problems will be recorded. The first group will receive the lowest dose of ASP4396. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396. The panel will do this until all groups have taken ASP4396 or until suitable doses have been selected for Part 2.
Part 2 is called Dose Expansion. Other different small groups of people will receive ASP4396 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP4396 to use in future studies.
In both parts of the study, ASP4396 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. People will continue treatment until: they have medical problems from the treatment they can't cope with (can't tolerate); their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.
People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. The study doctors will check for any medical problems from ASP4396. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during treatment with the option of a tumor sample being taken after treatment has finished.
People will visit the clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.
After this, people will visit the clinic for a health check several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.
After treatment has finished, people in the study will be followed up for up to 45 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP4396 Dose Escalation | Experimental | Drug: ASP4396Participants will receive ASP4396 in a 21-day cycle. |
| ASP4396 Dose Expansion | Experimental | Drug: ASP4396Participants will receive ASP4396 in a 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented KRAS G12D mutation and has received prior standard therapy.
- Participant has at least 1 measurable lesion per RECIST v1.1.
- Participant has an ECOG performance status of 0 or 1.
- Participant has adequate organ function.
Key exclusion criteria (8 listed)
- Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with asymptomatic and treated and stable CNS metastases are eligible.
- Participant has leptomeningeal disease as a manifestation of the current malignancy.
- Participant has another prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.
- Participant with active hepatitis B or hepatitis C virus (HCV).
- Participant has a known history of human immunodeficiency virus (HIV) infection with acquired immunodeficiency syndrome (AIDS)-related complications.
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 |
|---|---|---|
| ASP4396Intravenous (IV) infusion | Drug | ASP4396 Dose Escalation, ASP4396 Dose Expansion |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs) for ASP4369
Time frame: Up to 21 days
A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 at least possibly related to study intervention.
Number of Participants with Adverse Events (AEs)
Time frame: Up to 12 months
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 12 months
An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important events.
Number of Participants with laboratory value abnormalities and/or AEs
Time frame: Up to 12 months
Number of participants with potentially clinically significant laboratory values.
Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to 12 months
Number of participants with potentially clinically significant ECG values.
Number of Participants with vital sign abnormalities and/or AEs
Time frame: Up to 12 months
Number of participants with potentially clinically significant vital sign values.
Number of Participants with physical exam abnormalities and/or AEs
Time frame: Up to 12 months
Number of participants with potentially clinically significant physical exam values or symptoms.
Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score
Time frame: Up to 12 months
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
16 secondary outcomes
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 12 months
Duration of Response (DOR) per RECIST v 1.1
Time frame: Up to 12 months
Disease Control Rate (DCR) per RECIST v 1.1
Time frame: Up to 12 months
Progression Free Survival (PFS) per RECIST v1.1
Time frame: Up to 12 months
Overall Survival (OS)
Time frame: Up to 12 months
Pharmacokinetics (PK) of ASP4396 in plasma: area under the concentration-time curve from the time of dosing to 24 hours after dosing (AUC24h)
Time frame: Up to 12 months
PK of ASP4396 metabolite in plasma: AUC24h
Time frame: Up to 12 months
PK of ASP4396 in plasma: AUC168h
Time frame: Up to 12 months
PK of ASP4396 metabolite in plasma: AUC168h
Time frame: Up to 12 months
PK of ASP4396 in plasma: Maximum Concentration (Cmax)
Time frame: Up to 12 months
PK of ASP4396 metabolite in plasma: Cmax
Time frame: Up to 12 months
PK of ASP4396 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Up to 12 months
PK of ASP4396 metabolite in plasma: Ctrough
Time frame: Up to 12 months
PK of ASP4396 in plasma: Time of maximum concentration (tmax)
Time frame: Up to 12 months
PK of ASP4396 metabolite in plasma: tmax
Time frame: Up to 12 months
Change from baseline of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D amino acid substitution (G12D) tumor samples
Time frame: Baseline and up to 12 months
Results and safety
The study was stopped early (reason given: Company's strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Central Contact study director
Astellas Pharma Inc
7 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 ASP4396 in people with Solid Tumor, run by Astellas Pharma Inc at 7 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 was stopped early (reason given: Company's strategic decision). 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?
Incidence of Dose Limiting Toxicities (DLTs) for ASP4369 (time frame: Up to 21 days). The study lists 8 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 23 Oct 2026.