EGFR Mutation-Related TumorsPhase 1NCT05514496
A Study of NX-019 in Patients with Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer
A Phase 1 study testing NX-019 in people with EGFR Mutation-Related Tumors, run by Nalo Therapeutics Inc. at 12 sites in 3 countries.
Trial summary
This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of NX-019 and preliminary efficacy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Mutation-Related Tumors
- What is being tested?
- NX-019
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 5 Oct 2022to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, locally advanced, or metastatic EGFR-mutant cancer and has progressed on or are intolerant to all standard therapy.
- Patients with non-small cell lung cancer (NSCLC) harboring a mutation that is sensitive to osimertinib must have received osimertinib prior to enrollment.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (evaluable disease acceptable for dose escalation part of study).
- ≥18 years of age (or age of consent in in accordance with local law).
- Life expectancy ≥3 months.
- Adequate organ and bone marrow function.
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- All patients will have a baseline magnetic resonance imaging (MRI) of the brain.
- Resolution of any clinically significant toxic effects of prior therapy to Grade 0 or 1 according to the National Cancer Institute CTCAE v5.0 (exception of alopecia and Grade 2 peripheral neuropathy).
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Willingness of men and women of reproductive potential to observe conventional and effective birth control methods with failure rates of <1% for the duration of treatment and for 6 months following the last dose of study treatment.
- A negative serum pregnancy test at Screening and a negative (serum or urine) pregnancy test within 72 hours before the first dose of study drug (female patients of childbearing potential only).
- Willing and able to give informed consent and comply with protocol requirements for the duration of the study.
- Specific Inclusion Criteria for Expansion Cohorts:
- To be eligible during the expansion part of the study, patients must meet the above inclusion criteria, and the criteria for 1 of the following cohorts:
- Expansion Cohort 1:
- Patients with NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations who have progressed on or after prior EGFR TKI therapy.
- Expansion Cohort 2:
- Patients with NSCLC with EGFR ex20ins mutations, who are not suitable for, or are unwilling to receive available ex20ins mutation targeted therapy.
- Expansion Cohort 3:
- Patients with NSCLC with EGFR mutations for which there is no current targeted therapy, (i.e., exclusion of exon 19, exon 21 L858R, and ex20ins mutation).
Who cannot join
- Patients who meet any of the following criteria will be excluded from participation in the study:
- Known C797X EGFR mutations or 1 or more known secondary drivers of disease.
- Disease requiring immediate palliative treatment with surgery or radiation therapy.
- Requirement for greater than 4 mg/day of dexamethasone (or equivalent) for management of CNS metastases.
- Received systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy or an investigational agent within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study drug treatment.
- Major surgery within 3 weeks prior to start of study drug treatment.
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- Radiation therapy within 4 weeks prior to start of study drug treatment.
- Severe or unstable cardiac conditions within 6 months prior to starting study drug treatment.
- Severe or unstable medical condition including uncontrolled diabetes or unstable psychiatric condition.
- Dependent on contact lenses (unable to wear eyeglasses) and unable to comply with ophthalmic guidance.
- History of interstitial lung disease, radiation pneumonitis which required systemic steroid therapy, or other significant lung disease.
- Another active malignancy within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered cured, and, in the opinion of the Investigator, present a low risk of recurrence.
- Active infection requiring systemic therapy.
- Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) (i.e., hepatitis B surface antigen-positive), or hepatitis C virus (HCV) (i.e., detectable HCV ribonucleic acid [RNA]).
- Active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or conditions that may impact drug absorption.
- Pregnant or breastfeeding.
- Is using a strong CYP3A inhibitor or inducer, and cannot refrain from use from 7 days prior to the first dose and throughout the study.
- Is using a proton pump inhibitor and cannot refrain from use from 7 days prior to the first dose and throughout the study.
- Is using a sensitive substrate of P-gp with a narrow therapeutic window (e.g. digoxin).
- Any other condition, including significant skin or nail disease, that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully participate or comply with study procedures.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States7 sites
University Of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, 91010
NEXT Virginia
Fairfax, Virginia, 22031
City of Hope - Seacliff
Huntington Beach, California, 92648
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Taiwan1 site
National Taiwan University Cancer Center
Taipei City, Taipei, 10002
About this study
Official title: A First-in-Human, Open-Label, Dose Escalation and Expansion Study of Orally Administered NX-019 in Patients with Advanced, EGFR Mutant Cancer
This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of NX-019 and preliminary efficacy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant cancer.
Read the detailed description
Part 1: The primary objective of Part 1 of this study is to evaluate the safety and tolerability of NX-019 and to determine the maximum tolerated dose (MTD)/Recommended Expansion Dose(s) (REDs).
Part 2: The primary objective of Part 2 of this study is to confirm the safety and tolerability of NX-019 at the REDs and, for each expansion cohort, the preliminary evidence of efficacy as measured by objective response rate (ORR).
- Conditions
- EGFR Mutation-Related Tumors
- Being tested
- NX-019
- Keywords
- NX-019, EGFR Mutant Cancer, CNS Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-019Drug
NX-019 will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: NX-019 Dose Escalation | Experimental | Patients will be treated with NX-019 in multiple ascending cohorts. Receives: Drug: NX-019 |
| Part 2: NX-019 Dose Expansion | Experimental | Patients will be treated with the REDs of NX-019 as determined in Part 1. Receives: Drug: NX-019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and Part 2: Incidence of Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 4.5 years
Part 1 and Part 2: Incidence of Adverse Events of Special Interest (AESIs)
Measured: Up to 4.5 years
Part 1 and Part 2: Incidence of Serious Adverse Events (SAEs)
Measured: Up to 4.5 years
Part 2: Objective Response Rate
Measured: Up to 4.5 years
Secondary outcomes (21)
Part 1: Progression-free Survival (PFS)
Measured: Up to 4.5 years
Part 1: Objective Response Rate of NX-019
Measured: Up to 4.5 years
Part 1 and Part 2: Plasma Concentration of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Cerebrospinal Fluid (CSF) Concentration of NX-019
Measured: Up to 43 days
Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Area Under the Concentration Versus Time Curve (AUC) Over a Dosing interval (AUCtau) of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: AUC from Time 0 to the Time of Last Quantifiable Plasma Concentration (AUC0-t) of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: AUC from Time 0 to Infinity (AUC0-inf) of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Percent of AUC Extrapolated (AUC%extrap) of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Terminal Phase Elimination Half-life (t½) of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Terminal Phase Elimination Rate Constant (λz) of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Apparent Plasma Clearance (CL/F) of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Apparent Volume of Distribution (Vd/F) of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Accumulation Index Using Cmax (AICmax) and Accumulation Index Using AUC (AIAUC0-inf) of NX-019
Measured: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Time to Response (TTR)
Measured: Up to 4.5 years
Part 1 and Part 2: Duration of Response (DOR)
Measured: Up to 4.5 years
Part 1 and Part 2: Disease Control Rate (DCR)
Measured: Up to 4.5 years
Part 1 and Part 2: Overall Survival (OS)
Measured: Up to 4.5 years
Part 1 and Part 2: Objective Response Rate for CNS (central nervous system) Metastases
Measured: Up to 4.5 years
Part 1 and Part 2: TTR for CNS (central nervous system) Metastases
Measured: Up to 4.5 years
Part 1 and Part 2: DOR for CNS (central nervous system) Metastases
Measured: Up to 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start5 Oct 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutation-Related 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nalo Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514496
- Sponsor's protocol ID
- NT019-101
- Status last verified
- Mar 2025
- First submitted
- 22 Aug 2022
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open-Label, Dose Escalation and Expansion Study of Orally Administered NX-019 in Patients with Advanced, EGFR Mutant Cancer
- ClinicalTrials.gov ID
- NCT05514496
- Acronym / sponsor ID
- NT019-101
- Conditions
- EGFR Mutation-Related Tumors
- Keywords
- NX-019, EGFR Mutant Cancer, CNS Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Nalo Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Aug 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 is a 2-part, first-in-human, open-label study to determine the safety and tolerability of NX-019 and preliminary efficacy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant cancer.
Detailed description
Part 1: The primary objective of Part 1 of this study is to evaluate the safety and tolerability of NX-019 and to determine the maximum tolerated dose (MTD)/Recommended Expansion Dose(s) (REDs).
Part 2: The primary objective of Part 2 of this study is to confirm the safety and tolerability of NX-019 at the REDs and, for each expansion cohort, the preliminary evidence of efficacy as measured by objective response rate (ORR).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: NX-019 Dose Escalation | Experimental | Drug: NX-019Patients will be treated with NX-019 in multiple ascending cohorts. |
| Part 2: NX-019 Dose Expansion | Experimental | Drug: NX-019Patients will be treated with the REDs of NX-019 as determined in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically confirmed, locally advanced, or metastatic EGFR-mutant cancer and has progressed on or are intolerant to all standard therapy.
- Patients with non-small cell lung cancer (NSCLC) harboring a mutation that is sensitive to osimertinib must have received osimertinib prior to enrollment.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (evaluable disease acceptable for dose escalation part of study).
- ≥18 years of age (or age of consent in in accordance with local law).
- Life expectancy ≥3 months.
Key exclusion criteria (20 listed)
- Patients who meet any of the following criteria will be excluded from participation in the study:
- Known C797X EGFR mutations or 1 or more known secondary drivers of disease.
- Disease requiring immediate palliative treatment with surgery or radiation therapy.
- Requirement for greater than 4 mg/day of dexamethasone (or equivalent) for management of CNS metastases.
- Received systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy or an investigational agent within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study drug treatment.
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 |
|---|---|---|
| NX-019NX-019 will be administered orally. | Drug | Part 1: NX-019 Dose Escalation, Part 2: NX-019 Dose Expansion |
Primary outcome
Part 1 and Part 2: Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 4.5 years
Part 1 and Part 2: Incidence of Adverse Events of Special Interest (AESIs)
Time frame: Up to 4.5 years
Part 1 and Part 2: Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 4.5 years
Part 2: Objective Response Rate
Time frame: Up to 4.5 years
21 secondary outcomes
Part 1: Progression-free Survival (PFS)
Time frame: Up to 4.5 years
Part 1: Objective Response Rate of NX-019
Time frame: Up to 4.5 years
Part 1 and Part 2: Plasma Concentration of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Cerebrospinal Fluid (CSF) Concentration of NX-019
Time frame: Up to 43 days
Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Area Under the Concentration Versus Time Curve (AUC) Over a Dosing interval (AUCtau) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: AUC from Time 0 to the Time of Last Quantifiable Plasma Concentration (AUC0-t) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: AUC from Time 0 to Infinity (AUC0-inf) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Percent of AUC Extrapolated (AUC%extrap) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Terminal Phase Elimination Half-life (t½) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Terminal Phase Elimination Rate Constant (λz) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Apparent Plasma Clearance (CL/F) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Apparent Volume of Distribution (Vd/F) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Accumulation Index Using Cmax (AICmax) and Accumulation Index Using AUC (AIAUC0-inf) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Time to Response (TTR)
Time frame: Up to 4.5 years
Part 1 and Part 2: Duration of Response (DOR)
Time frame: Up to 4.5 years
Part 1 and Part 2: Disease Control Rate (DCR)
Time frame: Up to 4.5 years
Part 1 and Part 2: Overall Survival (OS)
Time frame: Up to 4.5 years
Part 1 and Part 2: Objective Response Rate for CNS (central nervous system) Metastases
Time frame: Up to 4.5 years
Part 1 and Part 2: TTR for CNS (central nervous system) Metastases
Time frame: Up to 4.5 years
Part 1 and Part 2: DOR for CNS (central nervous system) Metastases
Time frame: Up to 4.5 years
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 11 Mar 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NX-019 in people with EGFR Mutation-Related Tumors, run by Nalo Therapeutics Inc. at 12 sites in 3 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 20 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Part 1 and Part 2: Incidence of Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 4.5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.