PDACPhase 1/2NCT07145450
Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC
A Phase 1/2 study testing ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles), ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles) and ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles) in people with PDAC, run by Anocca AB at 10 sites in 4 countries.
Trial summary
This is an open-label, multi-centre, single-arm Phase 1/2 clinical trial of the safety, expansion, persistence and clinical activity of a set of engineered autologous T cells products each capable of recognizing a specific combination mutated KRAS and HLA, activating the T cells and exerting anti- tumour activity in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PDAC
- What is being tested?
- ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles), ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles) and ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 3 Jul 2025to 31 Jul 2030
- Phase
- Phase 1/2
- 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
- Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease.
- HLA genotyping confirmed with a high-resolution method.
- Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample.
- Fertile male and female patients must use a highly effective contraceptive method before, during, and for at least 6 months after the last mutKRAS TCR infusion. Acceptable contraception for women includes implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for male includes having had a vasectomy for at least 6 months, sexual abstinence, to condoms plus spermicide. Fertile female and male patients must adhere to any treatment-specific pregnancy prevention guidelines for cyclophosphamide (refer to SmPC).
- Confirmed clinical benefit to SoC treatments and absence of disease progression according to the PI judgement.
- Measurable disease by RECIST 1.1 criteria at the time of first treatment. Baseline imaging (for example, diagnostic CT of chest/abdomen/pelvis and imaging of the affected extremity or brain, as appropriate), or magnetic resonance imaging (MRI) must be obtained within 8 weeks of the first planned T cell infusion. CT can be substituted for MRI in patients unable to have CT contrast.
Who cannot join
- Another malignancy other than PDAC.
- Current or history of brain metastasis.
- Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.
Trial locations and contacts
10 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 4 countries
Germany6 sites, 6 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin
Antonia Busse, +49 30450513567, antonia.busse@charite.de
- Recruiting
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus
Dresden
Martin Wermke, +49 351 458-7566, Martin.Wermke@ukdd.de
- Recruiting
Universitaetsklinikum Heidelberg
Heidelberg
Christoph Springfeld, +49 6221 56 5615, christoph.springfeld@med.uni-heidelberg.de
- Not yet recruiting
Universitaetsklinikum Leipzig - Universitaeren Krebszentrum (UCCL)
Leipzig
Albrecht Hoffmeister, +493419712240, albrecht.hoffmeister@medizin.uni-leipzig.de
- Not yet recruiting
Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum der Universitaet Muenchen - Campus Grosshadern - Medizinische Klinik und Poliklinik III
München
Lena Weiss, +4915257906966, Lena.Weiss@med.uni-muenchen.de
- Recruiting
University Hospital and Faculty of Medicine Eberhard Karls University Tübingen
Tübingen
Wolfgang Bethge, +49 (0)7071 29-87121, wolfgang.bethge@med.uni-tuebingen.de
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC - VU Medical Center
Amsterdam
Johanna Willemijn Wilmink, +31(0)204444321, j.w.wilmink@amsterdamumc.nl
- Recruiting
Radboud University Medical Center
Nijmegen
Ingrid M.E. Desar, +31 243610353, Ingrid.Desar@radboudumc.nl
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte University Hospital
Copenhagen
Inna Chen, +45 38682898, inna.chen@regionh.dk
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Maximiliam Kordes, 08-123-83611, maximilian.kordes@regionstockholm.se
About this study
Official title: Phase 1/2 Master Protocol for Open-Label, Multi-Centre, Single-Arm Sub-Studies, First in Human Clinical Studies of TCR-T Therapy (Autologous TCR- Modified T-Cell Therapy) Targeting Mutated Kirsten Rat Sarcoma (mutKRAS) Administered in Metastatic or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) Adult Patients With Specific mutKRAS and Human Leukocyte Antigen (HLA) Genotypes
This is an open-label, multi-centre, single-arm Phase 1/2 clinical trial of the safety, expansion, persistence and clinical activity of a set of engineered autologous T cells products each capable of recognizing a specific combination mutated KRAS and HLA, activating the T cells and exerting anti- tumour activity in patients with metastatic or locally advanced PDAC.
Read the detailed description
This is a phase 1/2 study of engineered autologous T cells (TCR targeting KRAS G12V (ANOC-001 sub-study 1), (ANOC-002 sub-study 2) and KRAS 12D (ANOC-003 sub-study 3) capable of recognizing the tumour antigen(s), activating the T cells and exerting anti-tumour activity in patients with metastatic or locally advanced PDAC following a SoC first-line therapy.
The protocol procedures will be performed in two parts. Part 1 includes pre- screening/screening eligibility, enrolment and leukapheresis. Part 2 includes lymphodepletion, TCR-T cell infusion and all study assessments until the end-of-treatment or early discontinuation .
In the dose escalation part of each sub-study, two doses will be assessed in a classical 3+3 dose escalation design to assess the safety and tolerability of TCR-T cells with the goal to identify the optimal safe dose for each product.
- Conditions
- PDAC
- Being tested
- ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles), ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles), ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)Biological
The cells will be gene edited and administered by a single IV infusion on Day 1.
Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy.
ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)Biological
The cells will be gene edited and administered by a single IV infusion on Day 1. Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy.
ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles)Biological
The cells will be gene edited and administered by a single IV infusion on Day 1. Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| ANOC-001 | Other | Treatment Receives: Biological: ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles) |
| ANOC-002 | Other | Treatment Receives: Biological: ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles) |
| ANOC-003 | Other | Treatment Receives: Biological: ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1-Proportion of participants with dose limiting toxicity of ANOC-001, ANOC-002 and ANOC-003, graded according to American Society of Transplantation and Cellular Therapy (ASTCT) consensus criteria.
Measured: First infusion through Day 28
Phase 1-Number of participants with adverse events graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v5.0.
Measured: First infusion through Day 28
Phase 1- Identification of the Maximum tolerated dose/Maximum administered dose and Recommended Phase 2 Dose of ANOC-001/ANOC-002/ANOC-003 cells that can be administered safely in patients with metastatic and locally advanced PDAC.
Measured: First infusion through Day 28
Phase 2-Number of participants with adverse events of special interest (AESI) according to NCI CTCAE v5.0.
Measured: Baseline through 24 months post-treatment
Phase 2- Proportion of participants with Objective Response Rate (ORR) defined as the number of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) per RECIST v1.1 divided by the number of treated patients.
Measured: Baseline through 24 months post-treatment
Phase 2-Proportion of participants with Clinical benefit rate (CBR) defined as percentage of patients with stable disease (SD) more than 3 months, or PR/CR from the time of study treatment.
Measured: Baseline through 24 months post-treatment
Phase 2-Proportion of participants with Clinical benefit determined by the investigator, assessed anytime at 8- to 12-week intervals post TCR-T cell infusion.
Measured: Baseline through 24 months post-treatment
Secondary outcomes (6)
Phase 1 and Phase 2: Percentage of patients who receive protocol-defined target dose of ANOC-001, ANOC-002 and ANOC-003.
Measured: From leukapheresis through product release and infusion (Day 1), on an average of 2-4 months for each participant
Phase 1 and Phase 2: Proportion of investigational product- ANOC-001, ANOC-002 and ANOC-003 that comply with the specifications as compared to the total number of the IMP manufactured
Measured: From leukapheresis through product release and infusion (Day 1), on an average of 2-4 months for each participant
Phase 1 and Phase 2-Maximum expansion and persistence of TCR T cells following infusion by quantitative PCR
Measured: Baseline through 24 months post-treatment
Phase 1 and Phase 2- Proportion of participants achieving Progression Free Survival (PFS) defined as the time from study treatment to the first occurrence of disease progression or death, whichever occurs first.
Measured: Baseline through 24 months post-treatment
Phase 1 and Phase 2- Proportion of participants achieving Overall Survival (OS) defined as the time from study treatment to death from any cause.
Measured: Baseline through 24 months post-treatment
Phase 1 and Phase 2- Proportion of participants achieving Duration of Response (DoR) defined as the time from study treatment to disease progression or death in patients who achieve CR or PR.
Measured: Baseline through 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start3 Jul 2025
- Primary completion2 Apr 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDACStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anocca AB
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145450
- Sponsor's protocol ID
- CTP-ANOC-IS-001
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Master Protocol for Open-Label, Multi-Centre, Single-Arm Sub-Studies, First in Human Clinical Studies of TCR-T Therapy (Autologous TCR- Modified T-Cell Therapy) Targeting Mutated Kirsten Rat Sarcoma (mutKRAS) Administered in Metastatic or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) Adult Patients With Specific mutKRAS and Human Leukocyte Antigen (HLA) Genotypes
- ClinicalTrials.gov ID
- NCT07145450
- Acronym / sponsor ID
- CTP-ANOC-IS-001
- Conditions
- PDAC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Anocca ABOther government
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 2 Apr 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 28 Aug 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 an open-label, multi-centre, single-arm Phase 1/2 clinical trial of the safety, expansion, persistence and clinical activity of a set of engineered autologous T cells products each capable of recognizing a specific combination mutated KRAS and HLA, activating the T cells and exerting anti- tumour activity in patients with metastatic or locally advanced PDAC.
Detailed description
This is a phase 1/2 study of engineered autologous T cells (TCR targeting KRAS G12V (ANOC-001 sub-study 1), (ANOC-002 sub-study 2) and KRAS 12D (ANOC-003 sub-study 3) capable of recognizing the tumour antigen(s), activating the T cells and exerting anti-tumour activity in patients with metastatic or locally advanced PDAC following a SoC first-line therapy.
The protocol procedures will be performed in two parts. Part 1 includes pre- screening/screening eligibility, enrolment and leukapheresis. Part 2 includes lymphodepletion, TCR-T cell infusion and all study assessments until the end-of-treatment or early discontinuation .
In the dose escalation part of each sub-study, two doses will be assessed in a classical 3+3 dose escalation design to assess the safety and tolerability of TCR-T cells with the goal to identify the optimal safe dose for each product.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ANOC-001 | Other | Biological: ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)Treatment |
| ANOC-002 | Other | Biological: ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)Treatment |
| ANOC-003 | Other | Biological: ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles)Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease.
- HLA genotyping confirmed with a high-resolution method.
- Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample.
- Fertile male and female patients must use a highly effective contraceptive method before, during, and for at least 6 months after the last mutKRAS TCR infusion. Acceptable contraception for women includes implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for male includes having had a vasectomy for at least 6 months, sexual abstinence, to condoms plus spermicide. Fertile female and male patients must adhere to any treatment-specific pregnancy prevention guidelines for cyclophosphamide (refer to SmPC).
- Confirmed clinical benefit to SoC treatments and absence of disease progression according to the PI judgement.
Key exclusion criteria (3 listed)
- Another malignancy other than PDAC.
- Current or history of brain metastasis.
- Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.
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 |
|---|---|---|
| ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)The cells will be gene edited and administered by a single IV infusion on Day 1. Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy. | Biological | ANOC-001 |
| ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles)The cells will be gene edited and administered by a single IV infusion on Day 1. Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy. | Biological | ANOC-002 |
| ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles)The cells will be gene edited and administered by a single IV infusion on Day 1. Drugs: Cyclophosphamide and Fludarabine will be used as a lymphodepleting chemotherapy | Biological | ANOC-003 |
Primary outcome
Phase 1-Proportion of participants with dose limiting toxicity of ANOC-001, ANOC-002 and ANOC-003, graded according to American Society of Transplantation and Cellular Therapy (ASTCT) consensus criteria.
Time frame: First infusion through Day 28
Phase 1-Number of participants with adverse events graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v5.0.
Time frame: First infusion through Day 28
Phase 1- Identification of the Maximum tolerated dose/Maximum administered dose and Recommended Phase 2 Dose of ANOC-001/ANOC-002/ANOC-003 cells that can be administered safely in patients with metastatic and locally advanced PDAC.
Time frame: First infusion through Day 28
Phase 2-Number of participants with adverse events of special interest (AESI) according to NCI CTCAE v5.0.
Time frame: Baseline through 24 months post-treatment
Phase 2- Proportion of participants with Objective Response Rate (ORR) defined as the number of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) per RECIST v1.1 divided by the number of treated patients.
Time frame: Baseline through 24 months post-treatment
Phase 2-Proportion of participants with Clinical benefit rate (CBR) defined as percentage of patients with stable disease (SD) more than 3 months, or PR/CR from the time of study treatment.
Time frame: Baseline through 24 months post-treatment
Phase 2-Proportion of participants with Clinical benefit determined by the investigator, assessed anytime at 8- to 12-week intervals post TCR-T cell infusion.
Time frame: Baseline through 24 months post-treatment
6 secondary outcomes
Phase 1 and Phase 2: Percentage of patients who receive protocol-defined target dose of ANOC-001, ANOC-002 and ANOC-003.
Time frame: From leukapheresis through product release and infusion (Day 1), on an average of 2-4 months for each participant
Phase 1 and Phase 2: Proportion of investigational product- ANOC-001, ANOC-002 and ANOC-003 that comply with the specifications as compared to the total number of the IMP manufactured
Time frame: From leukapheresis through product release and infusion (Day 1), on an average of 2-4 months for each participant
Phase 1 and Phase 2-Maximum expansion and persistence of TCR T cells following infusion by quantitative PCR
Time frame: Baseline through 24 months post-treatment
Phase 1 and Phase 2- Proportion of participants achieving Progression Free Survival (PFS) defined as the time from study treatment to the first occurrence of disease progression or death, whichever occurs first.
Time frame: Baseline through 24 months post-treatment
Phase 1 and Phase 2- Proportion of participants achieving Overall Survival (OS) defined as the time from study treatment to death from any cause.
Time frame: Baseline through 24 months post-treatment
Phase 1 and Phase 2- Proportion of participants achieving Duration of Response (DoR) defined as the time from study treatment to disease progression or death in patients who achieve CR or PR.
Time frame: Baseline through 24 months 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 8 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for PDAC
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
Pancreatic Cancer, PDAC
RecruitingPhase 1/2
Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients
PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
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.
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ANOC-001 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles), ANOC-002 (TCR-T cells targeting KRAS G12V mutation presented by specific HLA alleles) and ANOC-003 (TCR-T cells targeting KRAS G12D mutation presented by specific HLA alleles) in people with PDAC, run by Anocca AB at 10 sites in 4 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 6 inclusion and 3 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Netherlands, Denmark, Sweden. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Amu Wang (+46703784946, amu.wang@anocca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1-Proportion of participants with dose limiting toxicity of ANOC-001, ANOC-002 and ANOC-003, graded according to American Society of Transplantation and Cellular Therapy (ASTCT) consensus criteria. (time frame: First infusion through Day 28). The study lists 7 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 8 Jun 2026.