Metastatic HER2 Positive Gastroesophageal Junction CancerPhase 1/2NCT05207722
CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma
A Phase 1/2 study testing CYNK-101, Pembrolizumab and Trastuzumab in people with Metastatic HER2 Positive Gastroesophageal Junction Cancer, run by Celularity Incorporated at 3 sites in United States.
Trial summary
This study will find the maximum tolerated dose (MTD) of CYNK-101 which contains Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-101 will be administered as first-line treatment, following induction therapy consisting of Pembrolizumab, Trastuzumab and a Fluoropyrimidine /… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic HER2 Positive Gastroesophageal Junction Cancer
- What is being tested?
- CYNK-101, Pembrolizumab and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Apr 2022to 15 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age on the day of signing informed consent.
- Have cytologically or histologically confirmed diagnosis for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-Positive Gastric or Gastroesophageal junction (G/GEJ) adenocarcinoma.
- Patients who have received adjuvant therapy more than 12 months prior to Visit 2 will be allowed to participate in the study. Any patient who has completed an INDUCTION regimen prior to study entry and achieved best tumor response as either (1) Stable Disease per RECIST after 6 cycles or (2) Progressive Disease per RECIST and meets all other inclusion/exclusion criteria per protocol, will be eligible for enrollment in this clinical trial to continue with LYMPHODEPLETION and NK CELL INDUCTION and MAINTENANCE.
- Patients will be required to undergo a biopsy for confirmation of HER2 expression prior to study entry.
- HER2 overexpression is defined by immunohistochemistry (IHC) or in situ hybridization (ISH) for amplification of HER2 gene.
- Patients must have either IHC 3+ or IHC 2+ with a positive fluorescent in-situ hybridization (FISH) or FISH + alone, as assessed locally on primary or metastatic tumor.
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- Due to differences in tumor histopathology, use of FDA-approved tests, specific for Gastric Cancers, will be required when assessing HER2 Expression [HERCEPTIN package insert; 202120].
- Have measurable disease as assessed by the investigator according to RECIST 1.1 [Eisenhauer EA et al, 200913].
- Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
- Have a life expectancy of ≥ 6 months.
- Patients must agree to use a highly effective method of contraception from the start of the study until 1 year after the last dose of lymphodepletion or 4 months from last dose of pembrolizumab, or 6 months from last dose of trastuzumab; whichever comes later.
- Have adequate cardiac function, defined as left ventricular ejection fraction > 45% as determined by MUGA scan or ECHO and QT interval calculated according to the Fridericia method (≤ 470 ms for men and ≤480 ms for women).
- Demonstrate adequate organ function by laboratory values as follows:
- Hematological:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L,
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
- Renal:
- o Calculated creatinine clearance (Cockcroft-Gault Formula) ≥ 50 mL/min
- Hepatic:
- o Total bilirubin ≤1.5 x ULN
- Exception: Patients with Gilbert's disease total bilirubin ≤ 3.0 x ULN
- o Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Exception: AST and ALT ≤ 5 x ULN for patients with liver metastases.
- Coagulation:
- Prothrombin Time (PT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy if PT or PTT is within therapeutic range of intended use of anticoagulants
- activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy if PT or PTT is within therapeutic range of intended use of anticoagulants
Who cannot join
- Patients who have received prior systemic therapy for locally advanced unresectable or metastatic disease.
- Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to Visit 2, or anticipation of the need for major surgery during the course of study treatment.
- Has had radiotherapy within 14 days prior to Visit 2.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Exceptions: Squamous or Basal cell carcinoma of the skin, superficial bladder cancer, and prostate cancer not requiring treatment.
- Patients with symptomatic, untreated, or actively progressing CNS metastases. Patients with a history of CNS metastases are eligible if they have not received radiotherapy within 7 days or whole-brain radiation for the past 14 days. Patients should not be receiving ongoing treatment with either corticosteroids or anticonvulsants. Patients with new CNS metastases detected during the Screening period, may participate in the study if they receive radiotherapy or surgery resulting in stable metastatic disease.
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- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Patients with hypothyroidism who are on stable replacement therapy will be allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy greater than 10 mg per day of prednisone or equivalent.
- Patients who require replacement for adrenal insufficiency will be allowed.
- Has a history of (non-infectious) pneumonitis that requires steroids or current pneumonitis.
- Has a known history of active tuberculosis.
- Has an active infection requiring systemic therapy.
- Accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 14 days prior to Visit 2. If the participant is receiving diuretic drugs for other reasons, it is acceptable.
- Has peripheral neuropathy > Grade 1.
- Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
- Has active or clinically significant cardiac disease including:
- History of myocarditis
- History or presence of serious uncontrolled cardiac arrhythmias.
- Clinically significant resting bradycardia.
- Left ventricular ejection fraction (LVEF) as determined by echocardiogram (ECHO) < 45% or multiple gated acquisition scan (MUGA) < 45%.
- Any of the following within 6 months prior to the start of the study treatments:
- myocardial infarction (MI), severe/unstable angina, congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA).
- Patients with history of human immunodeficiency virus (HIV) infection must be seronegative.
- Known active infection with hepatitis B, hepatitis C, SARS-CoV-2, or other viral infections requiring systemic therapy.
- Patients having a potential hypersensitivity (≥ Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents, rhIL-2 and/or to any excipients, murine proteins, or platinum-containing products. NOTE: any adverse events which has occurred because of prior therapy MUST have resolved to ≤ Grade 1 according to CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5 prior to study entry.
- Has had an allogeneic tissue/solid organ transplant.
- Immunized with live vaccine ≤ 28 days before Visit 2.
- Participation in study of investigational agent or device ≤ 28 day prior to Visit 2.
- Patient is pregnant or breastfeeding.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Scripps Health
La Jolla, California, 92037
Georgetown
Washington D.C., District of Columbia, 20057
About this study
Official title: A Phase I/IIa Open Label, Non-Randomized, Multicenter Study of CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Aenocarcinoma
This study will find the maximum tolerated dose (MTD) of CYNK-101 which contains Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-101 will be administered as first-line treatment, following induction therapy consisting of Pembrolizumab, Trastuzumab and a Fluoropyrimidine / Platinum based Chemotherapy regimen. Patients are required to undergo a biopsy for confirmation of HER2 positivity defined as either IHC 3+ or IHC 2+ with a positive fluorescent in-situ hybridization (FISH) or FISH + alone. The safety of this treatment will be evaluated, and researchers will want to learn if NK cells will help in treating patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma.
- Being tested
- CYNK-101, Pembrolizumab, Trastuzumab, Recombinant Human Interleukin-2, Cyclophosphamide
- Keywords
- CYNK-101, Natural Killer Cells, Cell Therapy, Metastatic HER2-positive Gastric Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYNK-101Biological
CYNK-101 is a human placental hematopoietic stem/progenitor cell derived NK cell product, that is genetically modified to express a variant of CD16, Fc gamma receptor III (FcγRIII).
PembrolizumabDrug
Also called Keytruda®
200 mg on Day 1 of each 3-week cycle as an IV infusion.
TrastuzumabDrug
Also called Herceptin®
8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.
Recombinant Human Interleukin-2Drug
Also called proleukin
6 million (M) international units (IU) of rhIL-2 administered subcutaneously (SC) on each CYNK-101 infusion day.
CyclophosphamideDrug
Also called cytoxan
Cyclophosphamide: 900 mg/m2 administered IV as part of a 3-day lymphodepletion regimen.
FludarabineDrug
Also called fludara
Fludarabine: 30 mg/m2 administered IV as part of a 3-day lymphodepletion regimen.
MesnaDrug
MESNA: shall be administered as part of a 3-day lymphodepletion regimen for the inhibition of hemorrhagic cystitis induced by cyclophosphamide. Route of administration, dosage, and frequency of Mesna should be based on institutional standards.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose Escalation | Experimental | Up to two dosing cohorts of CYNK-101 in combination with rhIL2 will be evaluated following an initial induction and lymphodepletion regimen. Receives: Biological: CYNK-101; Drug: Pembrolizumab; Drug: Trastuzumab; Drug: Recombinant Human Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna |
| Phase IIa Expansion | Experimental | Once the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) is determined in Phase I, the Phase IIa portion of the study will commence. Receives: Biological: CYNK-101; Drug: Pembrolizumab; Drug: Trastuzumab; Drug: Recombinant Human Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
Phase I
Measured: up to 28 days
Maximum Tolerated Dose (MTD)
Phase I
Measured: up to 28 days
Overall Response Rate (ORR) as determined by the RECIST 1.1 Investigator using RECIST 1.1.
Phase IIa
Measured: up to 12 months
Secondary outcomes (8)
Progression Free Survival (PFS)
Phase I/IIa
Measured: at 6 and 12 months
Duration of Response (DoR)
Phase I/IIa
Measured: up to 12 months
Overall Response Rate (ORR) as determined by the RECIST 1.1
Phase I
Measured: up to 12 months
Incidence of Response conversion post CYNK-101 infusion
Phase I/IIa
Measured: up to 12 months
Incidence of Treatment Emergent adverse events (TEAE)
Phase I/IIa
Measured: up to 12 months
Incidence and Severity of adverse events (AEs) and clinically significant changes in laboratory values
Phase I/IIa
Measured: up to 12 months
Incidence of replication competent lentivirus (RCL)
Phase I/IIa
Measured: up to 12 months
Overall Survival (OS)
Phase I/IIa
Measured: 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 posted26 Jan 2022
- Study start14 Apr 2022
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Why it stopped: for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic HER2 Positive Gastroesophageal Junction 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This Phase I/IIa study will utilize a 3+3 open label design, and will evaluate two escalating dosing Cohort levels of CYNK-101 in combination with rhIL2 following and initial induction and lymphodepletion regimen. Once the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) is determined in Phase I, the Phase IIa portion of the study will commence.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celularity Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Kilcoyne, MD, Study director, Celularity Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207722
- Sponsor's protocol ID
- CYNK-101-HER2-001
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Open Label, Non-Randomized, Multicenter Study of CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Aenocarcinoma
- ClinicalTrials.gov ID
- NCT05207722
- Acronym / sponsor ID
- CYNK-101-HER2-001
- Keywords
- CYNK-101, Natural Killer Cells, Cell Therapy, Metastatic HER2-positive Gastric Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: for business reasons
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Celularity IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will find the maximum tolerated dose (MTD) of CYNK-101 which contains Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-101 will be administered as first-line treatment, following induction therapy consisting of Pembrolizumab, Trastuzumab and a Fluoropyrimidine / Platinum based Chemotherapy regimen. Patients are required to undergo a biopsy for confirmation of HER2 positivity defined as either IHC 3+ or IHC 2+ with a positive fluorescent in-situ hybridization (FISH) or FISH + alone. The safety of this treatment will be evaluated, and researchers will want to learn if NK cells will help in treating patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This Phase I/IIa study will utilize a 3+3 open label design, and will evaluate two escalating dosing Cohort levels of CYNK-101 in combination with rhIL2 following and initial induction and lymphodepletion regimen. Once the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) is determined in Phase I, the Phase IIa portion of the study will commence.
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose Escalation | Experimental | Biological: CYNK-101, Drug: Pembrolizumab, Drug: Trastuzumab, Drug: Recombinant Human Interleukin-2, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaUp to two dosing cohorts of CYNK-101 in combination with rhIL2 will be evaluated following an initial induction and lymphodepletion regimen. |
| Phase IIa Expansion | Experimental | Biological: CYNK-101, Drug: Pembrolizumab, Drug: Trastuzumab, Drug: Recombinant Human Interleukin-2, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaOnce the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) is determined in Phase I, the Phase IIa portion of the study will commence. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Be at least 18 years of age on the day of signing informed consent.
- Have cytologically or histologically confirmed diagnosis for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-Positive Gastric or Gastroesophageal junction (G/GEJ) adenocarcinoma.
- Patients will be required to undergo a biopsy for confirmation of HER2 expression prior to study entry.
- Have measurable disease as assessed by the investigator according to RECIST 1.1 [Eisenhauer EA et al, 200913].
- Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
Key exclusion criteria (30 listed)
- Patients who have received prior systemic therapy for locally advanced unresectable or metastatic disease.
- Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to Visit 2, or anticipation of the need for major surgery during the course of study treatment.
- Has had radiotherapy within 14 days prior to Visit 2.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Patients with symptomatic, untreated, or actively progressing CNS metastases. Patients with a history of CNS metastases are eligible if they have not received radiotherapy within 7 days or whole-brain radiation for the past 14 days. Patients should not be receiving ongoing treatment with either corticosteroids or anticonvulsants. Patients with new CNS metastases detected during the Screening period, may participate in the study if they receive radiotherapy or surgery resulting in stable metastatic disease.
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 |
|---|---|---|
| CYNK-101CYNK-101 is a human placental hematopoietic stem/progenitor cell derived NK cell product, that is genetically modified to express a variant of CD16, Fc gamma receptor III (FcγRIII). | Biological | Phase I Dose Escalation, Phase IIa Expansion |
| PembrolizumabAlso: Keytruda®200 mg on Day 1 of each 3-week cycle as an IV infusion. | Drug | Phase I Dose Escalation, Phase IIa Expansion |
| TrastuzumabAlso: Herceptin®8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle. | Drug | Phase I Dose Escalation, Phase IIa Expansion |
| Recombinant Human Interleukin-2Also: proleukin6 million (M) international units (IU) of rhIL-2 administered subcutaneously (SC) on each CYNK-101 infusion day. | Drug | Phase I Dose Escalation, Phase IIa Expansion |
| CyclophosphamideAlso: cytoxanCyclophosphamide: 900 mg/m2 administered IV as part of a 3-day lymphodepletion regimen. | Drug | Phase I Dose Escalation, Phase IIa Expansion |
| FludarabineAlso: fludaraFludarabine: 30 mg/m2 administered IV as part of a 3-day lymphodepletion regimen. | Drug | Phase I Dose Escalation, Phase IIa Expansion |
| MesnaMESNA: shall be administered as part of a 3-day lymphodepletion regimen for the inhibition of hemorrhagic cystitis induced by cyclophosphamide. Route of administration, dosage, and frequency of Mesna should be based on institutional standards. | Drug | Phase I Dose Escalation, Phase IIa Expansion |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: up to 28 days
Phase I
Maximum Tolerated Dose (MTD)
Time frame: up to 28 days
Phase I
Overall Response Rate (ORR) as determined by the RECIST 1.1 Investigator using RECIST 1.1.
Time frame: up to 12 months
Phase IIa
8 secondary outcomes
Progression Free Survival (PFS)
Time frame: at 6 and 12 months
Duration of Response (DoR)
Time frame: up to 12 months
Overall Response Rate (ORR) as determined by the RECIST 1.1
Time frame: up to 12 months
Incidence of Response conversion post CYNK-101 infusion
Time frame: up to 12 months
Incidence of Treatment Emergent adverse events (TEAE)
Time frame: up to 12 months
Incidence and Severity of adverse events (AEs) and clinically significant changes in laboratory values
Time frame: up to 12 months
Incidence of replication competent lentivirus (RCL)
Time frame: up to 12 months
Overall Survival (OS)
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: for business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Adrian Kilcoyne, MD study director
Celularity Incorporated
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CYNK-101, Pembrolizumab and Trastuzumab in people with Metastatic HER2 Positive Gastroesophageal Junction Cancer, run by Celularity Incorporated at 3 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 27 inclusion and 30 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 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
The study was stopped early (reason given: for business reasons). 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?
Dose-Limiting Toxicity (DLT) (time frame: up to 28 days). The study lists 3 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 12 Dec 2024.