Small Cell Lung Cancer Extensive StagePhase 1/2Acclaim-3NCT05703971
Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
A Phase 1/2 study testing quaratusugene ozeplasmid and atezolizumab in people with Small Cell Lung Cancer Extensive Stage, run by Genprex, Inc. at 17 sites in United States.
Trial summary
This clinical trial will evaluate the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage
- What is being tested?
- quaratusugene ozeplasmid and atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 17 sitesUnited States
- Study dates
- 9 May 2024to Jun 2028
- 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
- Male or female aged ≥18 years.
- Documented history of histologically or cytologically confirmed ES-SCLC, prior to starting treatment with the combination of atezolizumab, carboplatin, and etoposide
- Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after receiving at least three cycles, and no more than four cycles, of atezolizumab, carboplatin, and etoposide.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1.
- Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement, and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery per Investigator assessment.
- Asymptomatic brain metastases must meet ALL criteria of the following (a-d):
Show all 18Show fewer
- No history of seizures in the preceding six months.
- Definitive treatment must be completed ≥21 days prior to enrollment.
- Must be off steroids administered because of brain metastases or related symptoms for ≥7 days.
- If had previous brain irradiation, post-treatment imaging must demonstrate stability or regression of the brain metastases.
- Absolute neutrophil count (ANC) >1500/mm3, platelet count >100,000/mm3 within ≤28 days.
- Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤28 days.
- Adequate hepatic function as documented by serum bilirubin <1.5 mg/dL and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X upper limit of normal (ULN) within ≤28 days.
- Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days.
- If female of childbearing potential (FOCBP), must have negative serum pregnancy test (serum beta-human chorionic gonadotropin [β-hCG]) within ≤7 days of first dose.
- FOCBP and non-sterile men who are sexually active with FOCBP must agree to use two forms of contraception including one highly effective and one effective methods beginning ≥2 weeks prior to enrollment through for four months following the last dose of study treatment.
- If male, must agree to no sperm donation during study treatment and for an additional four months following the last dose of study treatment.
- Must have voluntarily signed an informed consent in accordance with institutional policies.
Who cannot join
- Unable to tolerate atezolizumab treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications in previous atezolizumab treatment as determined by the Investigator.
- Received prior gene therapy.
- Received prophylactic cranial irradiation or consolidation thoracic radiation.
- Active systemic viral, bacterial, or fungal infection(s) requiring treatment.
- Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the Investigator, would not permit adequate follow-up and compliance with the study protocol.
- History of autoimmune disease requiring immunosuppression.
Show all 9Show fewer
- History of myocardial infarction or unstable angina within ≤6 months.
- Known human immunodeficiency virus (HIV) infection or has active hepatitis infection.
- Female who is pregnant or breastfeeding
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 16 recruiting
- Recruiting
Gabrail Cancer Center Research
Canton, Ohio, 44718
Carrie Smith, 330-417-8231, csmith@gabrailcancercenter.com
Kim Roby, 330.492.3345 ext. 227, kroby@gabrailcancercenter.com
- Recruiting
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45211
Douglas Hart, douglas.hart@usoncology.com
David M Waterhouse, MD
- Recruiting
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45236
Douglas Hart, douglas.hart@usoncology.com
David M Waterhouse, MD
- Recruiting
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45242
Douglas Hart, douglas.hart@usoncology.com
David M Waterhouse, MD
- Recruiting
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45245
Douglas Hart, douglas.hart@usoncology.com
David M Waterhouse, MD
- Recruiting
Texas Oncology - DFW
Dallas, Texas, 75246
Christine Terraciano, Christine.terraciano@usoncology.com
Kartik Konduri, MD
- Recruiting
Willamette Valley Cancer Institute (Oregon)
Eugene, Oregon, 97401
Jeanne Schaffer, jeanne.schaffer@usoncology.com
Bo Wang, MD
- Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Carrie Friedman, carrie.friedman@usoncology.com
Alexander I Spira, MD
- Recruiting
Oncology_Hematology Care Clinical Trials, LLC
Fairfield, Ohio, 45014
Douglas Hart, douglas.hart@usoncology.com
David M Waterhouse, MD
- Recruiting
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
Jennifer Hege, jennifer.hege@usoncology.com
Robert M Jotte, MD
- Recruiting
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213-2982
Jennifer Thompson, Jennifer.Thompson@usoncology.com
Anthony Van Ho, MD
- Recruiting
Providence Cancer Institute
Portland, Oregon, 97213
Brenda Fisher, RN, 503-215-1979, canrsrchstudies@providence.org
Rachel Sanborn, MD
- Recruiting
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227
Jennifer Thompson, Jennifer.Thompson@usoncology.com
Anthony Van Ho, MD
- Recruiting
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Medical Oncology Clinical Call Center, 314-747-1171, MedicalOncologyClinicalCallCenter@dom.wustl.edu
Daniel Morgensztern, MD
- Recruiting
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223
Jennifer Thompson, Jennifer.Thompson@usoncology.com
Anthony Van Ho, MD
- Recruiting
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Shelly Maxfield, shelly.maxfield@usoncology.com
Donald A Richards, MD
- Terminated
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
About this study
Official title: A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
This clinical trial will evaluate the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
The study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).
Read the detailed description
Acclaim-3 is an open-label, multi-center, Phase 1/2 study evaluating the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with ES-SCLC who did not develop tumor progression after receiving at least 3 cycles, and no more than 4 cycles, of induction therapy with carboplatin plus etoposide and atezolizumab.
Toxicities will be assessed by the Investigator using United States National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Serious Adverse Events and Dose Limiting Toxicities (DLTs) will be reviewed by a safety review committee.
Phase 1: Enrollment in Phase 1 is complete and the recommended Phase 2 dose (RP2D) of quaratusugene ozeplasmid when given in combination with atezolizumab was determined.
Phase 2: Enrollment has been initiated and enrolled patients are treated with quaratusugene ozeplasmid at the RP2D in combination with atezolizumab.
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Being tested
- quaratusugene ozeplasmid, atezolizumab
- Keywords
- atezolizumab, atezolizumab and hyaluronidase-tqjs, Tumor Suppressor Gene 2 (TUSC2), Lipid Nanoparticle (LNP), Gene Therapy, TECENTRIQ, ES-SCLC, REQORSA, quaratusugene ozeplasmid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quaratusugene ozeplasmidBiological
Also called REQORSA
Quaratusugene ozeplasmid is an experimental nonviral immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, reestablishing pathways that promote cancer cell death and modulating the immune response against cancer cells.
atezolizumabBiological
Also called TECENTRIQ
Atezolizumab is a monoclonal antibody that belongs to a class of drugs that binds to the programmed death-receptor 1 ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Up to 2 sequential dose selection cohorts will be treated with quaratusugene ozeplasmid (intravenous (IV) administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) until disease progression or unacceptable toxicity.
Quaratusugene ozeplasmid doses will be evaluated (0.09 [starting dose], and 0.12 mg/kg) until the RP2D is identified. Receives: Biological: quaratusugene ozeplasmid; Biological: atezolizumab |
| Phase 2 | Experimental | Patients will be treated with the RP2D of quaratusugene ozeplasmid (IV administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) or atezolizumab and hyaluronidase-tqjs (15 mL subcutaneous [SQ] administration once every 21 days) until disease progression or unacceptable toxicity Receives: Biological: quaratusugene ozeplasmid; Biological: atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1
The MTD and/or RP2D of the combination of quaratusugene ozeplasmid and atezolizumab.
Note: if a MTD is not determined, the RP2D will be selected based on all available data (safety, PK, PD, and preliminary efficacy).
Measured: First 21-days at each dose level
Progression-Free Survival Rate (PFSR) - Phase 2
PFSR at 18 weeks according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
Measured: 18-weeks from Day 1 of maintenance therapy
Secondary outcomes (4)
Safety Profile - Phase 1
Adverse events according to CTCAE v5.0
Measured: Approximately 6 months
Progression-free Survival (PFS) - Phase 1 & Phase 2
PFS per RECIST 1.1. PFS is defined as time from Day 1 of maintenance therapy to disease progression or death.
Measured: Approximately 5 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2
Concentration of quaratusugene ozeplasmid in whole blood samples.
Measured: First 21-day treatment cycle
Overall Survival (OS) - Phase 1 & Phase 2
Number of months from Day 1 of maintenance therapy to the date of death.
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start9 May 2024
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer Extensive StageStudies 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: 3+3 dose selection to identify RP2D. Phase 2: open label, non-randomized treatment with quaratusugene ozeplasmid at RP2D in combination with atezolizumab.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genprex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark S Berger, MD, Study director, Genprex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703971
- Sponsor's protocol ID
- ONC-005
- Acronym
- Acclaim-3
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Clinical Trial of Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
- ClinicalTrials.gov ID
- NCT05703971
- Acronym / sponsor ID
- Acclaim-3 / ONC-005
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Keywords
- atezolizumab, atezolizumab and hyaluronidase-tqjs, Tumor Suppressor Gene 2 (TUSC2), Lipid Nanoparticle (LNP), Gene Therapy, TECENTRIQ, ES-SCLC, REQORSA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Genprex, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 May 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Jan 2023 (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 clinical trial will evaluate the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
The study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).
Detailed description
Acclaim-3 is an open-label, multi-center, Phase 1/2 study evaluating the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with ES-SCLC who did not develop tumor progression after receiving at least 3 cycles, and no more than 4 cycles, of induction therapy with carboplatin plus etoposide and atezolizumab.
Toxicities will be assessed by the Investigator using United States National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Serious Adverse Events and Dose Limiting Toxicities (DLTs) will be reviewed by a safety review committee.
Phase 1: Enrollment in Phase 1 is complete and the recommended Phase 2 dose (RP2D) of quaratusugene ozeplasmid when given in combination with atezolizumab was determined.
Phase 2: Enrollment has been initiated and enrolled patients are treated with quaratusugene ozeplasmid at the RP2D in combination with atezolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1: 3+3 dose selection to identify RP2D. Phase 2: open label, non-randomized treatment with quaratusugene ozeplasmid at RP2D in combination with atezolizumab.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Biological: quaratusugene ozeplasmid, Biological: atezolizumabUp to 2 sequential dose selection cohorts will be treated with quaratusugene ozeplasmid (intravenous (IV) administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) until disease progression or unacceptable toxicity. Quaratusugene ozeplasmid doses will be evaluated (0.09 [starting dose], and 0.12 mg/kg) until the RP2D is identified. |
| Phase 2 | Experimental | Biological: quaratusugene ozeplasmid, Biological: atezolizumabPatients will be treated with the RP2D of quaratusugene ozeplasmid (IV administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) or atezolizumab and hyaluronidase-tqjs (15 mL subcutaneous [SQ] administration once every 21 days) until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female aged ≥18 years.
- Documented history of histologically or cytologically confirmed ES-SCLC, prior to starting treatment with the combination of atezolizumab, carboplatin, and etoposide
- Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after receiving at least three cycles, and no more than four cycles, of atezolizumab, carboplatin, and etoposide.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1.
- Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement, and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery per Investigator assessment.
Key exclusion criteria (9 listed)
- Unable to tolerate atezolizumab treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications in previous atezolizumab treatment as determined by the Investigator.
- Received prior gene therapy.
- Received prophylactic cranial irradiation or consolidation thoracic radiation.
- Active systemic viral, bacterial, or fungal infection(s) requiring treatment.
- Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the Investigator, would not permit adequate follow-up and compliance with the study protocol.
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 |
|---|---|---|
| quaratusugene ozeplasmidAlso: REQORSAQuaratusugene ozeplasmid is an experimental nonviral immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, reestablishing pathways that promote cancer cell death and modulating the immune response against cancer cells. | Biological | Phase 1, Phase 2 |
| atezolizumabAlso: TECENTRIQAtezolizumab is a monoclonal antibody that belongs to a class of drugs that binds to the programmed death-receptor 1 ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. | Biological | Phase 1, Phase 2 |
Primary outcome
Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1
Time frame: First 21-days at each dose level
The MTD and/or RP2D of the combination of quaratusugene ozeplasmid and atezolizumab. Note: if a MTD is not determined, the RP2D will be selected based on all available data (safety, PK, PD, and preliminary efficacy).
Progression-Free Survival Rate (PFSR) - Phase 2
Time frame: 18-weeks from Day 1 of maintenance therapy
PFSR at 18 weeks according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
4 secondary outcomes
Safety Profile - Phase 1
Time frame: Approximately 6 months
Progression-free Survival (PFS) - Phase 1 & Phase 2
Time frame: Approximately 5 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1 & Phase 2
Time frame: First 21-day treatment cycle
Overall Survival (OS) - Phase 1 & Phase 2
Time frame: Approximately 18 months
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 Sep 2026.
Related trials for Small Cell Lung Cancer Extensive Stage
Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
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.
Mark S Berger, MD study director
Genprex, Inc.
17 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 quaratusugene ozeplasmid and atezolizumab in people with Small Cell Lung Cancer Extensive Stage, run by Genprex, Inc. at 17 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 18 inclusion and 9 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
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 Sr Director, Clinical Operations (1-877-774-GNPX, kcombs@genprex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1 (time frame: First 21-days at each dose level). The study lists 2 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 Sep 2026.