Advanced or Metastatic Solid TumorsPhase 1/2NCT03665285
A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing NC318 in people with Advanced or Metastatic Solid Tumors and Lung Cancer, run by NextCure, Inc. at 6 sites in United States.
Trial summary
This research study is studying a new drug, NC318, as a possible treatment for advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors, Lung Cancer, Breast Cancer
- What is being tested?
- NC318
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Oct 2018to 11 Apr 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 or older.
- Willingness to provide written informed consent for the study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Subjects with advanced unresectable and/or metastatic solid tumors.
- Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. Note: There is no limit to the number of prior treatment regimens.
- Presence of measurable disease based on RECIST v1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other locoregional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
- Able to provide pretreatment tumor tissue sample at Screening.
- Subjects of childbearing potential (defined as female subjects who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy and are not postmenopausal, defined as ≥ 12 months of amenorrhea not caused by reversible conditions, diseases, or medications) and non-sterilized male subjects must agree to take appropriate precautions to avoid pregnancy or fathering children (with at least 99% certainty) from screening through 90 days after the last dose of study drug.
Who cannot join
- Inability to comprehend or unwilling to sign the Informed Consent Form.
- Screening laboratory values of:
- Absolute neutrophil count < 1.5 × 10^9/L
- Platelets < 100 × 10^9/L
- Hemoglobin < 9 g/dL or < 5.6 mmol/L
- Serum creatinine > 1.5 × institutional upper limit of normal (ULN)
Show all 31Show fewer
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 × ULN
- Total bilirubin > 1.5 × ULN.
- International normalized ratio (INR) or prothrombin time (PT) > 1.5 × ULN or activated partial thromboplastin time (aPTT) > 1.5 × ULN
- Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 7 days before the first administration of study drug.
- Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
- ≤ 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy. Subjects must also not require chronic use of corticosteroids and must not have had radiation pneumonitis because of a treatment. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease with medical monitor approval. Note: Bisphosphonates and denosumab are permitted medications.
- ≤ 28 days for prior immunotherapy or persistence of active cellular therapy (e.g., chimeric antigen receptor T cell therapy; other cellular therapies must be discussed with the medical monitor to determine eligibility).
- ≤ 28 days for a prior monoclonal antibody used for anticancer therapy except for denosumab.
- ≤ 7 days for immune-suppressive-based treatment for any reason. Note: Use of inhaled or topical steroids or corticosteroid use for radiographic procedures is permitted. Note: The use of corticosteroids equivalent to prednisone </= 10mg/day is allowed.
- ≤ 28 days or 5 half-lives (whichever is longer) before the first dose for all other investigational study drugs or devices.
- ≤ 14 days for COVID-19 vaccine.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
- Receipt of a live vaccine within 30 days of planned start of study therapy.
- Active autoimmune disease that required systemic treatment in the past (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Known active CNS metastases and/or carcinomatous meningitis.
- Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry after treatment with curative intent.
- Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
- Documented known activating or driver mutations (i.e. EGFR mutations/amplification, BRAF mutations, ALK alterations, etc.) which have not been previously treated with a standard of care targeted therapy.
- Subjects with screening QTc interval >470 milliseconds are excluded.
- Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti-infection treatment.
- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured.
- Known history of HIV (HIV 1 or HIV 2 antibodies).
- Known allergy or reaction to any component of study drug or formulation components.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study treatment.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Pennsylvania Cancer Specialists and Research Institute
Gettysburg, Pennsylvania, 17325
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Yale University Cancer Center
New Haven, Connecticut, 06510
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
NEXT Oncology
San Antonio, Texas, 78240
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors
This research study is studying a new drug, NC318, as a possible treatment for advanced or metastatic solid tumors.
- Conditions
- Advanced or Metastatic Solid Tumors, Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma, Endometrial Cancer, Melanoma
- Being tested
- NC318
- Keywords
- Advanced Cancer, Metastatic Cancer, NC318, Immunotherapy, PD-L1, Dose Escalation, Biomarker, PK, Cohort Expansion, Solid Tumor
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Endometrial Neoplasms, Melanoma, Carcinoma, Transitional Cell, Cholangiocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC318Drug
NC318 is an experimental antibody drug that may make the immune response more active against cancer.
| Study group | Role | What they receive |
|---|---|---|
| NC318 8mg | Experimental | Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC318 |
| NC318 24mg | Experimental | Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC318 |
| NC318 80mg | Experimental | Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC318 |
| NC318 240mg | Experimental | Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC318 |
| NC318 400mg | Experimental | Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC318 |
| NC318 800mg | Experimental | Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC318 |
| NC318 1600mg | Experimental | Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC318 |
| Dose Expansion: 400mg Q2W | Experimental | Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC318 |
| Dose Expansion: 800mg QW | Experimental | Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC318 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
The number of participants who have had at least one TEAE during the study.
Measured: From enrollment through up to 90 days after end of treatment, an average of 1 year
Secondary outcomes (8)
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Approximately 1 year
Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Measured: Approximately 1 year
Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Approximately 1 year
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To evaluate progression-free survival (PFS), defined as the time from the first dose of NC318 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Approximately 1 year
Overall Survival (OS)
To evaluate overall survival (OS), defined as the time from the first dose of NC318 to death due to any cause.
Measured: Approximately 1 year
Maximum Plasma Concentration (Cmax) of NC318
To evaluate the Maximum Plasma Concentration (Cmax) of NC318
Measured: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.
Area Under the Curve (AUC) of NC318
To evaluate the Area Under the Curve (AUC) of NC318
Measured: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.
Half-life (t1/2) of NC318
To evaluate the half-life (t1/2) of NC318
Measured: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Oct 2018
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced or Metastatic Solid TumorsStudies 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
- Phase 1 will utilize a 3 + 3 design to explore escalating dose levels. Phase 2 Dose Expansion will further evaluate the safety, tolerability, preliminary efficacy, and PK/PD activity of NC318 at the RP2D utilizing a Simon 2-stage design.
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- NextCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Han Myint, MD, Study director, NextCure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665285
- Sponsor's protocol ID
- NC318-01
- Status last verified
- Mar 2024
- First submitted
- 6 Sep 2018
- Last updated
- 8 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03665285
- Acronym / sponsor ID
- NC318-01
- Conditions
- Advanced or Metastatic Solid Tumors, Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma, Endometrial Cancer, Melanoma
- Keywords
- Advanced Cancer, Metastatic Cancer, NC318, Immunotherapy, PD-L1, Dose Escalation, Biomarker, PK
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- NextCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Posted 8 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a new drug, NC318, as a possible treatment for advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Phase 1 will utilize a 3 + 3 design to explore escalating dose levels. Phase 2 Dose Expansion will further evaluate the safety, tolerability, preliminary efficacy, and PK/PD activity of NC318 at the RP2D utilizing a Simon 2-stage design.
| Arm | Type | Receives |
|---|---|---|
| NC318 8mg | Experimental | Drug: NC318Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 24mg | Experimental | Drug: NC318Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 80mg | Experimental | Drug: NC318Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 240mg | Experimental | Drug: NC318Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 400mg | Experimental | Drug: NC318Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 800mg | Experimental | Drug: NC318Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| NC318 1600mg | Experimental | Drug: NC318Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| Dose Expansion: 400mg Q2W | Experimental | Drug: NC318Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| Dose Expansion: 800mg QW | Experimental | Drug: NC318Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged 18 or older.
- Willingness to provide written informed consent for the study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Subjects with advanced unresectable and/or metastatic solid tumors.
- Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. Note: There is no limit to the number of prior treatment regimens.
Key exclusion criteria (31 listed)
- Inability to comprehend or unwilling to sign the Informed Consent Form.
- Screening laboratory values of:
- Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 7 days before the first administration of study drug.
- Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
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 |
|---|---|---|
| NC318NC318 is an experimental antibody drug that may make the immune response more active against cancer. | Drug | Dose Expansion: 400mg Q2W, Dose Expansion: 800mg QW, NC318 1600mg, NC318 240mg, NC318 24mg, NC318 400mg, NC318 800mg, NC318 80mg, NC318 8mg |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Time frame: From enrollment through up to 90 days after end of treatment, an average of 1 year
The number of participants who have had at least one TEAE during the study.
8 secondary outcomes
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Overall Survival (OS)
Time frame: Approximately 1 year
Maximum Plasma Concentration (Cmax) of NC318
Time frame: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.
Area Under the Curve (AUC) of NC318
Time frame: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.
Half-life (t1/2) of NC318
Time frame: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Han Myint, MD study director
NextCure, Inc.
6 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 NC318 in people with Advanced or Metastatic Solid Tumors and Lung Cancer, run by NextCure, Inc. at 6 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 8 inclusion and 31 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: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 (time frame: From enrollment through up to 90 days after end of treatment, an average of 1 year). 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 Mar 2024.