AzTrials
AzTrials

Extensive-stage Small-cell Lung CancerPhase 2NCT06449209

Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy

A Phase 2 study testing BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2) and Etoposide in people with Extensive-stage Small-cell Lung Cancer and Small-cell Lung Cancer, run by BioNTech SE at 64 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or second-line treatment (Cohort 2 and Cohort 3). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2) and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
64 sitesin 5 countries
Study dates
5 Aug 2024to Feb 2028
Phase
Phase 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

None listed.

Who cannot join

  • Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the study or within 6 months after the last dose of IMP.
  • Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the study, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol-described requirements.
  • Have histologically or cytologically confirmed SCLC with combined histologies.
  • Have received any of the following therapies or drugs within the noted time intervals prior to the initiation of study treatment:
  • Within 2 weeks: small molecule targeted agents with half-life of <7 days; or radiation not involving the thoracic cavity; local radiation for brain lesion is allowed; local radiation for bone lesions is allowed.
  • Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
Show all 49Show fewer
  • Participants who received prior treatment with a PDL-1/VEGF bispecific antibody.
  • Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 10 days prior to the initiation of study treatment. Note: The following are allowed: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).
  • Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of the study treatment.
  • Received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of study treatment.
  • Use of any non-study IMP within 3 weeks before initiation of study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study.
  • Have undergone major organ surgery (core needle biopsies are allowed >7 days prior study start), significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of study treatment or plan to undergo elective surgery during the study. Placement of vascular infusion devices is allowed.
  • Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
  • Have the following central nervous system metastases:
  • Participants with untreated brain metastases that are symptomatic or large (e.g., >2 cm).
  • Participants who received treatment for central nervous system metastases are not neurologically stable or still on steroids 10 days before initiating IMP of this study.
  • Participants with known leptomeningeal metastases.
  • Have active autoimmune disease or history of autoimmune diseases with anticipated relapse (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for those with clinically stable autoimmune thyroid disease or type 1 diabetes.
  • Have had other malignant tumors within 2 years prior to the study treatment are not allowed. Except for those: who have been cured with local treatment (such as basal cell or squamous cell carcinoma of the skin, superficial or non-invasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, papillary carcinoma of thyroid and early stage prostate cancer).
  • Have any of the following heart conditions within 6 months prior to the study treatment:
  • Acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, stroke, or other Grade 3 and above cardiovascular and cerebrovascular events.
  • New York Heart Association functional classification ≥II heart failure or left ventricular ejection fraction <50%.
  • Those who have ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, or congenital long QT syndrome. Participants with treated cardiac arrythmia/atrial fibrillation are allowed.
  • Mean QT interval corrected by Fridericia's method >480 ms (the electrocardiogram can be repeated at the discretion of the investigator).
  • Use of cardiac pacemaker.
  • Cardiac troponin I or T >2 x ULN.
  • Have any of the following hypertension or diabetic conditions prior to initiation of study treatment:
  • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) while on antihypertensive medicine.
  • Those with a history of hypertensive crisis or hypertensive encephalopathy.
  • Poorly controlled diabetes (fasting blood glucose ≥13.3 mmol/L [240 mg/dL]).
  • Have serious non-healing wounds, ulcers, or bone fractures. This includes history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before enrollment into this study. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
  • Participants with evidence of major coagulation disorders or other significant risks of hemorrhage such as:
  • History of intracranial or intraspinal hemorrhage.
  • Tumor lesions invading large vessels and with significant risk of bleeding
  • Had clinically significant hemoptysis or tumor hemorrhage within 1 month prior to the initiation of study treatment.
  • Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Participants with indwelling catheters (e.g., PleurX) are allowed. However, participants who are clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis or with indwelling catheters, e.g., PleurX) are allowed.
  • Participants with a history of serious Grade 3 or higher immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy. Participants with a history of Grade ≥3 irAEs that did not lead to discontinuation of a prior immunotherapy but fully recovered may be enrolled per investigator's discretion. The investigator may request sponsor guidance in such cases.
  • Have a known or suspected hypersensitivity to the study treatments including any active ingredient or excipients thereof.
  • Have known human immunodeficiency virus infection or known acquired immunodeficiency syndrome, with the following exceptions:
  • Participants with cluster of differentiation 4 (CD4)+ T-cell (CD4+) counts ≥350 cells/µL per local laboratory should generally be eligible for the study.
  • Participants who have not had an opportunistic infection within the past 12 months.
  • Have a known history/positive serology for hepatitis B requiring active antiviral therapy (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy). Individuals with positive serology must have hepatitis B virus viral load below the limit of quantification.
  • Have an active hepatitis C virus infection; individuals who have completed curative antiviral treatment with hepatitis C virus viral load below the limit of quantification are allowed.
  • Participants with AEs from prior antitumor therapy whose AE(s) have not returned to Grade 1 (graded by NCI CTCAE v5.0 criteria) or below (unless the investigator determines that certain AEs pose no safety risk to participants, such as hair loss, Grade 2 peripheral neuropathy or stable hypothyroidism under hormone replacement therapy) are not eligible for the study.
  • Have superior vena cava syndrome or symptoms of spinal cord compression.
  • Those with active, or a history of, pneumonitis requiring treatment with steroids, or has active, or a history of, interstitial lung disease. Those with a history of pulmonary fibrosis, or currently diagnosed with severe lung diseases such as interstitial pneumonia, pneumoconiosis, chemical pneumonitis, or any other condition resulting in significant impairment in lung function. Exception: Asymptomatic interstitial changes caused by previous radiation therapy, chemotherapy, or other factors such as smoking are acceptable.
  • Have active tuberculosis.
  • Have underlying condition(s) that may increase the risk of the combination treatment or complicate the interpretation of AEs, as judged by the investigator, or other scenarios in which the investigator consider the participant as not eligible for the study.
  • Are vulnerable individuals, i.e., are individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. This includes all sponsor, study site, or third party (e.g., contract research organization, vendor) personnel directly involved in the conduct of the sudy and their family members or dependents, as well as all study site personnel otherwise supervised by the investigator.

Trial locations and contacts

64 sites in 5 countries.

64 sites in 5 countries

Turkey (Türkiye)21 sites

  • Baskent University Hospital Adana Dr Turgut Noyan Research Center

    Adana, 01120

  • Medical Park Seyhan Hospital

    Adana, 01230

  • Adana City Training and Research Hospital

    Adana, 4522

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010

  • Ankara Etlik Sehir Hastanesi

    Ankara, 06170

  • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200

  • Hacettepe University Medical Faculty Oncology Hospital

    Ankara, 06230

  • Memorial Ankara Hospital

    Ankara, 06520

  • Liv Hospital

    Ankara, 06680

  • Ankara City Hospital

    Ankara, 06800

  • Gaziantep Sanko University Medical Faculty

    Gaziantep, 36020

  • Koc Universitesi Hastanesi (Koc University Hospital)

    Istanbul, 34010

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Acibadem Adana Hastanesi

    Istanbul, 34457

  • Yeditepe University Kosuyolu Hospital

    Istanbul, 34718

  • Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Medical Point Izmir Hospital

    Izmir, 35325

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Sakarya University - Faculty of Medicine

    Sakarya, 54290

  • Namik Kemal University Hospital

    Tekirdağ, 59030

  • Gazi University Medical Faculty

    Yenimahalle, 06560

Other trials in Turkey (Türkiye)

United States18 sites

  • Alaska Oncology and Hematology, LLC

    Anchorage, Alaska, 99508

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

  • Clermont Oncology Center

    Clermont, Florida, 34711

  • Haywood Infusion Center

    Clyde, North Carolina, 28721-8046

  • SSM Health Cancer Care - St. Clare

    Fenton, Missouri, 63026

  • Fort Wayne Medical Oncology and Hematology, Inc

    Fort Wayne, Indiana, 46804

  • Millenium Research & Clinical Development

    Houston, Texas, 77090

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center)

    Lexington, Kentucky, 40536

  • Nebraska Hematology-Oncology (NHO) - Lincoln

    Lincoln, Nebraska, 68506

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • SSM Health Cancer Care

    Madison, Wisconsin, 53715

  • Allina Health

    Minneapolis, Minnesota, 55407

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Hematology Oncology Associates of Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Tallahassee Memorial Physician Partners - Cancer & Hematology Specialists

    Tallahassee, Florida, 32308

  • Carle Foundation Hospital d/b/a Carle Cancer Center

    Urbana, Illinois, 61801

  • Clinical Research Alliance Inc

    Westbury, New York, 11590

Other trials in United States

United Kingdom11 sites

  • Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW

  • Velindre Hospital - Velindre NHS Trust

    Cardiff, CF14 2TL

  • Ninewells Hospital and Medical School - Tayside Health Board

    Dundee, DD1 9SY

  • Royal Devon and Exeter Hospital, Wonford - Royal Devon And Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust

    Huddersfield, HD3 3EA

  • St James's University Hospital - Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • Northern Centre for Cancer Care,The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, PR2 9HT

  • Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

South Korea9 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Yeungnam University Medical Center

    Daegu, 42415

  • National Cancer Center

    Goyang-si, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Gyeongsang National University Hospital (GNUH)

    Jinju, 52727

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 06591

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Australia5 sites

  • Lyell McEwin Hospital

    Adelaide, 5112

  • St. Vincent's Hospital

    Fitzroy, 3065

  • Peninsula Oncology Centre

    Frankston, 3199

  • Royal North Shore Hospital

    St Leonards, 2065

  • Westmead Hospital

    Westmead, 2145

Other trials in Australia

About this study

Official title: A Phase II, Multi-site, Open-label, Parallel Group Trial of BNT327 in Combination With Chemotherapy for Participants With Untreated Extensive-stage Small-cell Lung Cancer and Participants With Previously Treated Small-cell Lung Cancer

This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or second-line treatment (Cohort 2 and Cohort 3). This study will assess the safety, efficacy, and pharmacokinetics (PK) of BNT327.

Read the detailed description

In Cohort 1 of this study, two dose levels of BNT327 will be studied in combination with etoposide and carboplatin to identify an optimized dose for future clinical investigation.

Cohort 2 and Cohort 3 will explore the combination of two dose levels of BNT327 with paclitaxel, or topotecan in the second- or third-line setting.

Patients will be treated until disease progression, intolerable toxicity, patient withdrawal, study termination or up to 2 years (whichever occurs first).

Participants will be assigned to either Cohort 1 or Cohort 2/Cohort 3 based on their disease type (i.e., untreated ES-SCLC for Cohort 1 and SCLC which has progressed on first- or second-line treatment for Cohort 2 and Cohort 3). Assignment to either Cohort 2 or Cohort 3 will be the investigator's choice.

Participants will be randomized to each arm within each cohort:

  • Participants enrolled to Cohort 1 and Cohort 3 will be randomized in a 1:1 ratio to Arm 1 or Arm 2.
  • Participants enrolled to Cohort 2 will be randomized in a 2:1 ratio to Arm 1 or Arm 2.
Being tested
BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2), Etoposide, Carboplatin, Paclitaxel
Keywords
Programmed Death-1 (PD-1), Programmed Death Ligand-1 (PD-L1), Programmed Death-1 monoclonal antibodies, Combination chemotherapy, Anti vascular endothelial growth factor (VEGF), Previously treated small-cell lung cancer, Untreated extensive-stage small-cell lung cancer, Dose optimization, Time to progression
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT327 Dose Level 1 (DL1)Drug

    Intravenous (IV) infusion

  • BNT327 Dose Level 2 (DL2)Drug

    IV infusion

  • EtoposideDrug

    IV infusion

  • CarboplatinDrug

    IV infusion

  • PaclitaxelDrug

    IV infusion

  • TopotecanDrug

    IV infusion or oral capsules

Study groups in NCT06449209
Study groupRoleWhat they receive
Cohort 1 Arm 1 - BNT327 DL1 + carboplatin + etoposideExperimentalParticipants with ES-SCLC without prior systemic anticancer therapy received in the ES setting
Receives: Drug: BNT327 Dose Level 1 (DL1); Drug: Etoposide; Drug: Carboplatin
Cohort 1 Arm 2 - BNT327 DL2 + carboplatin + etoposideExperimentalParticipants with ES-SCLC without prior systemic anticancer therapy received in the ES setting
Receives: Drug: BNT327 Dose Level 2 (DL2); Drug: Etoposide; Drug: Carboplatin
Cohort 2 Arm 1 - BNT327 DL1 + paclitaxelExperimentalParticipants with SCLC who have disease progression/relapse
Receives: Drug: BNT327 Dose Level 1 (DL1); Drug: Paclitaxel
Cohort 2 Arm 2 - BNT327 DL2 + paclitaxelExperimentalParticipants with SCLC who have disease progression/relapse
Receives: Drug: BNT327 Dose Level 2 (DL2); Drug: Paclitaxel
Cohort 3 Arm 1 - BNT327 DL1 + topotecanExperimentalParticipants with SCLC who have disease progression/relapse
Receives: Drug: BNT327 Dose Level 1 (DL1); Drug: Topotecan
Cohort 3 Arm 2 - BNT327 DL2 + topotecanExperimentalParticipants with SCLC who have disease progression/relapse
Receives: Drug: BNT327 Dose Level 2 (DL2); Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-related serious adverse events (SAEs) and treatment-related treatment emergent SAEs

    In the combination treatment regimen according to the (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). By treatment arm and overall.

    Measured: up to 100 days after the last dose of treatment

  2. Occurrence of dose interruption, reduction, and discontinuation of study treatment due to TEAEs

    By treatment arm and overall.

    Measured: up to 100 days after the last dose of treatment

  3. Objective Response Rate

    Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment) is observed as best overall response. By treatment arm.

    Measured: until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment

  4. Best percentage change from baseline in the tumor size

    Based on the investigator's tumor assessment according to RECIST 1.1. Defined as the change from baseline in percent to the minimal tumor size until tumor progression/recurrence or death (whichever comes first). By treatment arm.

    Measured: Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment

  5. Proportion of participants who have achieved early tumor shrinkage

    Defined as ≥10% decrease in the pretreatment sum of diameters at first post-treatment tumor scan in target lesions. By treatment arm.

    Measured: up to 2 months after first dose of treatment

Secondary outcomes (10)

  1. PK assessment: Maximum concentration (Cmax) derived from serum concentration of investigational medicinal product (IMP)

    By treatment arm. Only for the first cycle.

    Measured: from pre-dose to 21 days after study treatment

  2. PK assessment: Area under the curve during the dosing interval (AUCtau) values derived from serum concentration of IMP

    By treatment arm. Only for the first cycle.

    Measured: from pre-dose to 21 days after study treatment

  3. Incidence of detectable BNT327 antidrug antibodies in serum

    By treatment arm and overall.

    Measured: from pre-dose to 100 days after last dose of study treatment

  4. Duration of Response

    Defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression or death from any cause, whichever occurs first based on investigator's review.

    Measured: up to 24 months after completion of study treatment of the last participant

  5. Disease Control Rate

    Defined as the proportion of participants in whom a confirmed CR or PR or stable disease (per RECIST 1.1, stable disease assessed at least 6 weeks after first dose) is observed as best overall response based on the investigator's review.

    Measured: up to 24 months after completion of study treatment of the last participant

  6. Time to Response

    Defined as the time from randomization to first objective response (CR or PR per RECIST 1.1) based on the investigator's review.

    Measured: up to 24 months after completion of study treatment of the last participant

  7. Progression-Free Survival (PFS)

    Based on the investigator's tumor assessment according to RECIST 1.1. Defined as the time from randomization to first confirmed objective tumor progression (progressive disease per RECIST 1.1), or death from any cause, whichever occurs first.

    Measured: up to 24 months after completion of study treatment of the last participant

  8. PFS rate

    As measured at 6, 12, 18, and 24 months

    Measured: up to 24 months after completion of study treatment of the last participant

  9. Overall Survival (OS)

    Defined as the time from randomization to death from any cause

    Measured: up to 24 months after completion of study treatment of the last participant

  10. OS rate

    As measured at 6, 12, 18, and 24 months

    Measured: up to 24 months after completion of study treatment of the last participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2024
  2. Study start5 Aug 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06449209
Sponsor's protocol ID
BNT327-01
Status last verified
Nov 2026
First submitted
3 Jun 2024
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2) and Etoposide in people with Extensive-stage Small-cell Lung Cancer and Small-cell Lung Cancer, run by BioNTech SE at 64 sites in 5 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 0 inclusion and 49 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Turkey (Türkiye), United States, United Kingdom, South Korea, Australia. 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 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?

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?

Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-related serious adverse events (SAEs) and treatment-related treatment emergent SAEs (time frame: up to 100 days after the last dose of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06449209.

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 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in