Advanced Malignant Solid NeoplasmPhase 1/2NCT04552704
CD24Fc for the Treatment of Immune Related Adverse Events in Patients With Advanced Solid Tumors, TIRAEC Study
A Phase 1/2 study testing CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc in people with Advanced Malignant Solid Neoplasm, run by Tianhong Li at 1 site in United States.
Trial summary
This phase I/II trial investigates the side effects and how well CD24Fc works in treating immune related adverse events in patients with solid tumors that have spread to other places in the body (advanced). CD24Fc may prevent autoimmune reactions due to the tissue damage induced by cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm
- What is being tested?
- CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 26 Jan 2022
- 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
- Ability to understand and willingness to sign an informed consent form
- At least 18 years of age
- Histologically confirmed advanced solid tumors
- Patients must have grade 2 or 3 irAEs from at least one ICI-containing regimen. Both newly emerging and persistent irAEs are allowed. Systemic steroid therapy or any other form of immunosuppressive therapy for irAEs is allowed. The specific irAEs are
- Grade 2-3 diarrhea/colitis: Patients with >= 4 stools per day or moderate-severe increase in ostomy output compared to baseline but not life-threatening diarrhea
- Grade 2-3 pneumonitis: Mild to moderate (grade 2) or severe (grade 3) symptoms (including hypoxia, shortness of breath, requiring oxygen) but not life-threatening respiratory compromise requiring urgent intervention (e.g., tracheostomy or intubation)
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- Grade 2-3 renal irAE: Creatine increased between 1.6-6.0 x upper limit of normal (ULN) or =< 3.0 x baseline if baseline was abnormal, estimated glomerular filtration rate (eGFR) or creatinine clearance >= 15 ml/min/1.73m^2 but not life-threatening consequences or requiring dialysis
- Grade 2-3 Hepatic irAE: AST/ALT/ALP levels 3-20 x ULN, and T bilirubin increased <5 x ULN
- Grade 2-3 skin rash: moderate (10-30% body surface area, BSA) to severe (> 30% BSA) but not life-threatening skin lesions or Stevens-Johnson syndrome
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Life expectancy of >= 3 months at the time of enrollment
- Pretreatment absolute neutrophil count (ANC) >= 1,000/uL obtained within 14 days prior to 1st dose of treatment
- Pretreatment hemoglobin >= 8 gm/dL obtained within 14 days prior to 1st dose of treatment
- Pretreatment platelet count of >= 75,000/uL obtained within 14 days prior to 1st dose of treatment
- Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for >= 1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Or, female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first study drug administration
- Male and female subjects who agree to use highly effective method of birth control (e.g., implants, injectables, birth control pills with two hormones, intrauterine devices [IUDs], complete abstinence or sterilized partner, and female sterilization) and a barrier method (e.g., condoms, vaginal ring, sponge, etc.) during the period of therapy and for 90 days after the last dose of study drug
Who cannot join
- Prior CD24Fc therapy
- Any known active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, including patients who have an active infection requiring systemic therapy. History of COVID-19 or known asymptomatic carrier of SARS-CoV-2 virus is allowed
- Pregnant or lactating women
- Any medical condition including additional laboratory abnormalities, or psychiatric illness that would, in the opinion of the investigator, prevent the subject from participating and adhering to study related procedures
- Any known severe bacterial, fungal, or viral infection that in the opinion of the investigator would interfere with patient safety or compliance on trial within 2 weeks prior to enrollment
- Patients with concomitant proarrhythmic medications
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- Patients with heart failure in New York (NY) Heart Association stage IV
- Any grade 4 irAE symptoms and Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade 4 toxicity
- AST, ALT, gamma glutamyl transpeptidase (GGT), or ALP > 20.0 x ULN regardless of baseline
- Blood bilirubin >5.0 x ULN regardless of baseline
- Creatinine > 6.0 x ULN or creatinine clearance <15 ml/min/1.73m2
- Urine: Anuria < 140 ml in 24 hours
- Electrolytes hyponatremia, sodium < 120 mmol/L
- Hypokalemia, potassium < 2.5 mmol/L
- Creatine kinase (CPK) > 10.0 ULN
- Electrocardiogram (ECG): Prolonged QT interval >= 480 mS, corrected by Fridericia's formula. Torsade de pointes; polymorphic ventricular tachycardia; signs/symptoms of serious arrythmia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: Treatment of Immune Related Adverse Events With CD24Fc (TIRAEC)
This phase I/II trial investigates the side effects and how well CD24Fc works in treating immune related adverse events in patients with solid tumors that have spread to other places in the body (advanced). CD24Fc may prevent autoimmune reactions due to the tissue damage induced by cancer treatment. CD24Fc binds to injured cell components and prevents inflammatory responses. CD24Fc also acts to turn off the immune system after it has been activated ("immune checkpoint"). Adding CD24Fc to standard treatment may shorten the recovery time and reduce the severity of side effects from immunotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of CD24 extracellular domain-IgG1 Fc domain recombinant fusion protein CD24Fc (CD24Fc) in patients with advanced solid tumors who developed debilitating immune-related adverse events (irAEs) from immune check point inhibitors (ICIs). (Phase I) II. To determine if CD24Fc shortens the recovery time of irAE and increases the recovery rate of irAE in cancer patients with grade (G)2 or 3 irAEs. (Randomized phase II)
SECONDARY OBJECTIVES:
- Time to irAE reduction by at least 1 grade. (Phase I) II. Time to all irAEs reduced to grade =< 1. (Phase I) III. Time to resume ICI treatment. (Phase I) IV. Recovery rate (as defined by reduction of irAE by one grade) at day (D)42. (Phase I) V. To estimate the time to all irAEs reduced to =< 1. (Randomized phase II) VI. To record the use of steroids (drug, dose, duration) and other treatment for irAE. (Randomized phase II) VII. To record the time to resume ICI treatment. (Randomized phase II) VIII. To estimate the preliminary overall response rate (ORR), progression free survival (PFS), and 1-year overall survival (OS) after treatment with or without CD24Fc. (Randomized phase II) IX. To determine if CD24Fc treatment changes the levels of inflammatory markers in the plasma. (Randomized phase II)
OUTLINE:
PHASE I: Patients receive CD24Fc intravenously (IV) over 60 minutes on days 1, 14, and 28 with standard of care (i.e., steroids per treating physician and best supportive care) in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at days 42 and 60 and then every 3 months for up to 1 year.
- Conditions
- Advanced Malignant Solid Neoplasm
- Being tested
- CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc, Placebo Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24FcBiological
Also called CD24Fc, CD24Fc CD24IgG
Given IV
Placebo AdministrationDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Phase I (CD24Fc) | Experimental | Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care (i.e., steroids per treating physician and best supportive care) in the absence of disease progression or unacceptable toxicity. Receives: Biological: CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc |
| Phase II, Arm I (CD24Fc) | Experimental | Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity. Receives: Biological: CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc |
| Phase II, Arm II (placebo) | Placebo comparator | Patients receive placebo IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity. Receives: Drug: Placebo Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With New Adverse Event (AE) of Grade >= 3 (Phase I)
Number of Participants with New Adverse Event (AE) of Grade >= 3 (Phase I)
Measured: At day 60
Recovery Rate (Phase II)
Defined by reduction of irAE by one grade. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measured: At day 42
Time to Recovery From Grade 2 or 3 irAE (Phase II)
Will assess time to recovery from grade 2 or 3 irAE (as defined by reduction of at least 1 grade in irAE severity) from the initiation of CD24Fc treatment. Patients who have not been documented to have event (reduction of at least 1 grade) will be censored at the date of the latest clinical assessment that documented as being free of event.
Measured: Up to 1 year
Secondary outcomes (9)
Time to irAE Reduction by at Least 1 Grade From the Initiation of CD24Fc Treatment (Phase I)
Time to irAE reduction by at least 1 grade from the initiation of CD24Fc treatment.
Measured: Up to 1 year
Time to All irAEs Reduced to =< 1 From the Initiation of CD24Fc Treatment (Phase I)
Time to all irAEs reduced to =< 1 from the initiation of CD24Fc treatment (Phase I)
Measured: Up to 2 weeks
Time to Resume Immune Check Point Inhibitor (ICI) Treatment From the Initiation of CD24Fc Treatment (Phase I)
Time to resume immune check point inhibitor (ICI) treatment from the initiation of CD24Fc treatment (Phase I)
Measured: Up to about 3.5 months
Recovery Rate (Reduction of irAE by One Grade) (Phase I)
The fraction of patients who experience a partial response (PR) or complete response (CR) will be determined by dividing the number of responders by the total evaluable patients.
Measured: At day 42
Time to All irAEs Reduced to =< 1 From the Initiation of CD24Fc Treatment (Phase II)
Time to all irAEs reduced to =< 1 from the initiation of CD24Fc treatment (Phase II)
Measured: Up to 1 year
Use of Steroids and Other Drugs (Phase II)
Summary of use of steroids and other treatment for irAE.
Measured: Up to 1 year
Overall Response Rate After Retreatment With ICI With or Without CD24Fc After Resolution of irAE (Phase II)
The fraction of patients who experience a PR or CR will be determined by dividing the number of responders by the total evaluable patients.
Measured: Up to 1 year
Progression Free Survival (PFS) (Phase II)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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: From initiation of ICI to first documented evidence of disease progression or death, whichever comes first, assessed up to 1 year
Overall Survival (OS) (Phase II)
Count of participants known to be alive up to 1 year from the time from start of treatment.
Measured: From start of treatment to death, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start30 Oct 2020
- Primary completion3 Feb 2021
- Study completion26 Jan 2022
Why it stopped: Terminated early by the Sponsor due to business reason.
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 Malignant Solid NeoplasmStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianhong Li
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Sponsor-investigator, Tianhong Li, University of California, Davis
- Investigators
- Tianhong Li, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552704
- Sponsor's protocol ID
- 1626396
- Other IDs
- NCI-2020-05955, UCDCC#292, P30CA093373, CD24Fc-006
- Status last verified
- Jul 2026
- First submitted
- 10 Sep 2020
- Last updated
- 10 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Immune Related Adverse Events With CD24Fc (TIRAEC)
- ClinicalTrials.gov ID
- NCT04552704
- Acronym / sponsor ID
- 1626396
- Conditions
- Advanced Malignant Solid Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early by the Sponsor due to business reason.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Tianhong LiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Posted 4 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial investigates the side effects and how well CD24Fc works in treating immune related adverse events in patients with solid tumors that have spread to other places in the body (advanced). CD24Fc may prevent autoimmune reactions due to the tissue damage induced by cancer treatment. CD24Fc binds to injured cell components and prevents inflammatory responses. CD24Fc also acts to turn off the immune system after it has been activated ("immune checkpoint"). Adding CD24Fc to standard treatment may shorten the recovery time and reduce the severity of side effects from immunotherapy.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of CD24 extracellular domain-IgG1 Fc domain recombinant fusion protein CD24Fc (CD24Fc) in patients with advanced solid tumors who developed debilitating immune-related adverse events (irAEs) from immune check point inhibitors (ICIs). (Phase I) II. To determine if CD24Fc shortens the recovery time of irAE and increases the recovery rate of irAE in cancer patients with grade (G)2 or 3 irAEs. (Randomized phase II)
SECONDARY OBJECTIVES:
- Time to irAE reduction by at least 1 grade. (Phase I) II. Time to all irAEs reduced to grade =< 1. (Phase I) III. Time to resume ICI treatment. (Phase I) IV. Recovery rate (as defined by reduction of irAE by one grade) at day (D)42. (Phase I) V. To estimate the time to all irAEs reduced to =< 1. (Randomized phase II) VI. To record the use of steroids (drug, dose, duration) and other treatment for irAE. (Randomized phase II) VII. To record the time to resume ICI treatment. (Randomized phase II) VIII. To estimate the preliminary overall response rate (ORR), progression free survival (PFS), and 1-year overall survival (OS) after treatment with or without CD24Fc. (Randomized phase II) IX. To determine if CD24Fc treatment changes the levels of inflammatory markers in the plasma. (Randomized phase II)
OUTLINE:
PHASE I: Patients receive CD24Fc intravenously (IV) over 60 minutes on days 1, 14, and 28 with standard of care (i.e., steroids per treating physician and best supportive care) in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at days 42 and 60 and then every 3 months for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I (CD24Fc) | Experimental | Biological: CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24FcPatients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care (i.e., steroids per treating physician and best supportive care) in the absence of disease progression or unacceptable toxicity. |
| Phase II, Arm I (CD24Fc) | Experimental | Biological: CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24FcPatients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity. |
| Phase II, Arm II (placebo) | Placebo comparator | Drug: Placebo AdministrationPatients receive placebo IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of 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 (16 listed)
- Ability to understand and willingness to sign an informed consent form
- At least 18 years of age
- Histologically confirmed advanced solid tumors
- Patients must have grade 2 or 3 irAEs from at least one ICI-containing regimen. Both newly emerging and persistent irAEs are allowed. Systemic steroid therapy or any other form of immunosuppressive therapy for irAEs is allowed. The specific irAEs are
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
Key exclusion criteria (16 listed)
- Prior CD24Fc therapy
- Any known active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, including patients who have an active infection requiring systemic therapy. History of COVID-19 or known asymptomatic carrier of SARS-CoV-2 virus is allowed
- Pregnant or lactating women
- Any medical condition including additional laboratory abnormalities, or psychiatric illness that would, in the opinion of the investigator, prevent the subject from participating and adhering to study related procedures
- Any known severe bacterial, fungal, or viral infection that in the opinion of the investigator would interfere with patient safety or compliance on trial within 2 weeks prior to enrollment
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 |
|---|---|---|
| CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24FcAlso: CD24Fc, CD24Fc CD24IgGGiven IV | Biological | Phase I (CD24Fc), Phase II, Arm I (CD24Fc) |
| Placebo AdministrationGiven IV | Drug | Phase II, Arm II (placebo) |
Primary outcome
Number of Participants With New Adverse Event (AE) of Grade >= 3 (Phase I)
Time frame: At day 60
Number of Participants with New Adverse Event (AE) of Grade >= 3 (Phase I)
Recovery Rate (Phase II)
Time frame: At day 42
Defined by reduction of irAE by one grade. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Time to Recovery From Grade 2 or 3 irAE (Phase II)
Time frame: Up to 1 year
Will assess time to recovery from grade 2 or 3 irAE (as defined by reduction of at least 1 grade in irAE severity) from the initiation of CD24Fc treatment. Patients who have not been documented to have event (reduction of at least 1 grade) will be censored at the date of the latest clinical assessment that documented as being free of event.
9 secondary outcomes
Time to irAE Reduction by at Least 1 Grade From the Initiation of CD24Fc Treatment (Phase I)
Time frame: Up to 1 year
Time to All irAEs Reduced to =< 1 From the Initiation of CD24Fc Treatment (Phase I)
Time frame: Up to 2 weeks
Time to Resume Immune Check Point Inhibitor (ICI) Treatment From the Initiation of CD24Fc Treatment (Phase I)
Time frame: Up to about 3.5 months
Recovery Rate (Reduction of irAE by One Grade) (Phase I)
Time frame: At day 42
Time to All irAEs Reduced to =< 1 From the Initiation of CD24Fc Treatment (Phase II)
Time frame: Up to 1 year
Use of Steroids and Other Drugs (Phase II)
Time frame: Up to 1 year
Overall Response Rate After Retreatment With ICI With or Without CD24Fc After Resolution of irAE (Phase II)
Time frame: Up to 1 year
Progression Free Survival (PFS) (Phase II)
Time frame: From initiation of ICI to first documented evidence of disease progression or death, whichever comes first, assessed up to 1 year
Overall Survival (OS) (Phase II)
Time frame: From start of treatment to death, assessed up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tianhong Li, MD, PhD principal investigator
University of California, Davis
1 site 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 CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc in people with Advanced Malignant Solid Neoplasm, run by Tianhong Li at 1 site 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 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 4 Apr 2022). 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 New Adverse Event (AE) of Grade >= 3 (Phase I) (time frame: At day 60). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.