Solid TumorsPhase 1/2NCT02959437
Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)
A Phase 1/2 study testing Azacitidine, Pembrolizumab and Epacadostat in people with Solid Tumors and Advanced Malignancies, run by Incyte Corporation at 12 sites in 3 countries.
Trial summary
This is an open-label, Phase 1/2 study in subjects with advanced or metastatic solid tumors. The study has three separate treatment groups where separate epigenetic agents are evaluated with an immunotherapy combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Advanced Malignancies, Metastatic Cancer
- What is being tested?
- Azacitidine, Pembrolizumab and Epacadostat
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 27 Feb 2017to 2 Mar 2020
- 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
- Willingness to provide written informed consent for the study.
- Willingness to undergo a pretreatment and on-treatment tumor biopsy to obtain tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Part 1: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject refusal or intolerance is also allowable).
- Part 2:
- Note: Subjects must have failed available therapies that are known to confer clinical benefit as indicated below, unless they are ineligible, intolerant, or refused standard treatment.
Show all 25Show fewer
- Subjects with histologically or cytologically confirmed NSCLC:
- Metastatic (Stage IV) or recurrent NSCLC (according to American Joint Committee on Cancer 7th edition guidelines) who have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
- Prior systemic regimens must include previously approved therapies, including a platinum-containing chemotherapy regimen; a tyrosine kinase inhibitor for tumors with driver mutations; and checkpoint inhibitors where approved.
- Must have disease progression on a prior PD-1-pathway targeted agent.
- Subjects with recurrent (unresectable) or metastatic CRC:
- Have histologically confirmed microsatellite stable (MSS) CRC.
- Stage IV MSS CRC (according to American Joint Committee on Cancer 7th edition guidelines) who have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
- Prior systemic regimens must include previously approved therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF therapy (if no contraindication); and if negative for KRAS, NRAS, and BRAF mutations and no contraindication, an anti-epidermal growth factor receptor (EGFR) therapy; and progressed after the last administration of approved therapy.
- Subjects with HNSCC:
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
- Carcinomas of the nasopharynx, salivary gland, or nonsquamous cell histology are excluded.
- Must have received prior treatment with a platinum-based therapy
- Must have had documented disease progression while on a prior PD-1 pathway-targeted agent.
- Subjects with melanoma:
- Histologically or cytologically confirmed melanoma.
- Unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer staging system not amenable to local therapy.
- Subjects with urothelial carcinoma:
- Histologically or cytologically confirmed urothelial carcinoma of the renal pelvis, ureter, urinary bladder, or urethra that is transitional cell or mixed transitional/nontransitional (predominantly transitional) cell type.
- Stage IV locally advanced or metastatic urothelial carcinoma (according to American Joint Committee on Cancer 7th edition guidelines) with documented disease progression while on a PD-1 pathway targeted therapy.
Who cannot join
- Laboratory parameters not within the protocol-defined range.
- Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
- Has not recovered from toxic effects of prior therapy to ≤ Grade 1.
- Active or inactive autoimmune disease or syndrome.
- Active infection requiring systemic therapy.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Show all 14Show fewer
- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
- Has received a live vaccine within 30 days of planned start of study therapy.
- Prior receipt of an IDO inhibitor.
- Subjects with uncontrolled type I or type II diabetes mellitus (defined as HgbA1c > 8).
- Prior receipt of a BET inhibitor (Treatment Group B only).
- Subjects with a history of bleeding related to cancer under study requiring a medical intervention (eg, embolization procedure, RBC transfusion, or hospitalization) within 30 days of study enrollment (Treatment Groups B and C only).
- Clinically significant bleeding within 14 days of Cycle 1 Day 1 (Treatment Groups B and C only).
- Prior receipt of an LSD1 inhibitor including INCB059872 (Treatment Group C only).
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States8 sites
The University of Chicago
Chicago, Illinois, 60637
City of Hope National Medical Center
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92093
Sarah Cannon
Nashville, Tennessee, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19014
University of Washington
Seattle, Washington, 98109
United Kingdom2 sites
University College London Hospitals (Uclh)
London, W1t7ha
Churchill Hospital
Oxford, Ox37le
About this study
Official title: A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Stage IV Microsatellite-Stable Colorectal Cancer (ECHO-206)
This is an open-label, Phase 1/2 study in subjects with advanced or metastatic solid tumors. The study has three separate treatment groups where separate epigenetic agents are evaluated with an immunotherapy combination. Treatment Group A will evaluate the DNA methyltransferase inhibitor azacitidine in combination with the programmed death receptor-1 (PD-1) inhibitor pembrolizumab and the indoleamine 2,3-dioxygenase (IDO-1) inhibitor epacadostat; Treatment Group B will evaluate the bromodomain and extra-terminal (BET) inhibitor INCB057643 with pembrolizumab and epacadostat; and Treatment Group C will evaluate the lysine-specific demethylase 1A (LSD1) inhibitor INCB059872 with pembrolizumab and epacadostat. The study will be divided into 2 parts (Part 1 and 2). Part 1 is a dose-escalation assessment to evaluate the safety and tolerability of the combination therapies. Once the recommended doses have been determined, subjects with previously treated NSCLC, microsatellite-stable colorectal cancer (CRC), head and neck squamous cell carcinoma, urothelial carcinoma, and melanoma will be enrolled into expansion cohorts in Part 2.
- Conditions
- Solid Tumors, Advanced Malignancies, Metastatic Cancer
- Being tested
- Azacitidine, Pembrolizumab, Epacadostat, INCB057643, INCB059872
- Keywords
- Solid tumors, NSCLC, CRC
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Five doses of azacitidine will be administered by subcutaneous injection or intravenously (IV) over Days 1 to 7 in Cycles 1 through 6.
PembrolizumabDrug
Pembrolizumab will be administered in a 30-minute IV infusion every 3 weeks on Day 1 of each 21-day cycle.
EpacadostatDrug
Epacadostat tablets will be administered orally twice daily.
INCB057643Drug
INCB057643 will be orally self- administered once daily beginning on Cycle 1 Day 1 and continuously thereafter in 21-day cycles.
PembrolizumabDrug
Pembrolizumab will be administered in a 30-minute IV infusion every 3 weeks of each 21-day cycle starting on Cycle 2 Day 1.
EpacadostatDrug
Epacadostat tablets will be administered orally twice daily starting at Cycle 2 Day 1.
INCB059872Drug
INCB059872 will be orally self- administered once daily OR every other day beginning on Cycle 1 Day 1 and continuously thereafter in 21-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A: Azacitidine + Pembrolizumab + Epacadostat | Experimental | Part 1 is an open-label 3 + 3 + 3 dose-escalation design based on observing each dose level for a period of 21 days. Part 2 will evaluate the recommended dose determined in Part 1. Receives: Drug: Azacitidine; Drug: Pembrolizumab; Drug: Epacadostat |
| Treatment Group B: INCB057643 + Pembrolizumab + Epacadostat | Experimental | Part 1 is an open-label 3 + 3 + 3 dose-escalation design based on observing each dose level for a period of 42 days. Part 1 will also contain dose-expansion cohorts in previously treated NSCLC and MSS CRC. Part 2 will evaluate the recommended dose determined in Part 1. Receives: Drug: INCB057643; Drug: Pembrolizumab; Drug: Epacadostat |
| Treatment Group C: INCB059872 + Pembrolizumab + Epacadostat | Experimental | Part 1 is an open-label 3 + 3 + 3 dose-escalation design based on observing each dose level for a period of 42 days. Part 1 will also contain dose-expansion cohorts in previously treated NSCLC and MSS CRC. Part 2 will evaluate the recommended dose determined in Part 1. Receives: Drug: Pembrolizumab; Drug: Epacadostat; Drug: INCB059872 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and 2 : Number of Participants With Treatment Emergent Adverse Events
A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
Measured: Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period).
Part 1 and 2: Objective Response Rate Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. A participant was considered as an objective responder if the participant had a best overall response of CR or PR.
Measured: Every 9 weeks for the duration of study participation; estimated minimum of 6 months.
Secondary outcomes (3)
Parts 1 and 2: Percentage of Responders Determined by Immunohistochemistry
Responder is defined as an increase in the number of tumor-infiltrating lymphocytes or the ratio of CD8+ lymphocytes to T regulatory cells infiltrating tumor post-treatment versus pretreatment with pembrolizumab and epacadostat in combination with azacitidine.
Measured: Baseline to Week 5/6 or week 8/9
Parts 1 and 2: Progression-free Survival Based on RECIST v1.1.
Defined as the time from date of first dose of study drug until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Measured: Every 9 weeks from date of randomization until the date of first documented progression or date of death from any cause whichever came first, assessed up to 24 months
Parts 1 and 2: Duration of Response Based on RECIST v1.1
Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Measured: Every 9 weeks from date of randomization until the date of first documented progression or date of death from any cause whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start27 Feb 2017
- Primary completion15 Feb 2019
- Study completion2 Mar 2020
Why it stopped: Study terminated by Sponsor
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 Solid TumorsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin O'Hayer, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959437
- Sponsor's protocol ID
- INCB 24360-206 / ECHO-206
- Other IDs
- 2016-004289-25, 2016
- Status last verified
- Oct 2025
- First submitted
- 7 Nov 2016
- Last updated
- 21 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Stage IV Microsatellite-Stable Colorectal Cancer (ECHO-206)
- ClinicalTrials.gov ID
- NCT02959437
- Acronym / sponsor ID
- INCB 24360-206 / ECHO-206
- Conditions
- Solid Tumors, Advanced Malignancies, Metastatic Cancer
- Keywords
- Solid tumors, NSCLC, CRC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by Sponsor
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Posted 5 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, Phase 1/2 study in subjects with advanced or metastatic solid tumors. The study has three separate treatment groups where separate epigenetic agents are evaluated with an immunotherapy combination. Treatment Group A will evaluate the DNA methyltransferase inhibitor azacitidine in combination with the programmed death receptor-1 (PD-1) inhibitor pembrolizumab and the indoleamine 2,3-dioxygenase (IDO-1) inhibitor epacadostat; Treatment Group B will evaluate the bromodomain and extra-terminal (BET) inhibitor INCB057643 with pembrolizumab and epacadostat; and Treatment Group C will evaluate the lysine-specific demethylase 1A (LSD1) inhibitor INCB059872 with pembrolizumab and epacadostat. The study will be divided into 2 parts (Part 1 and 2). Part 1 is a dose-escalation assessment to evaluate the safety and tolerability of the combination therapies. Once the recommended doses have been determined, subjects with previously treated NSCLC, microsatellite-stable colorectal cancer (CRC), head and neck squamous cell carcinoma, urothelial carcinoma, and melanoma will be enrolled into expansion cohorts in Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A: Azacitidine + Pembrolizumab + Epacadostat | Experimental | Drug: Azacitidine, Drug: Pembrolizumab, Drug: EpacadostatPart 1 is an open-label 3 + 3 + 3 dose-escalation design based on observing each dose level for a period of 21 days. Part 2 will evaluate the recommended dose determined in Part 1. |
| Treatment Group B: INCB057643 + Pembrolizumab + Epacadostat | Experimental | Drug: INCB057643, Drug: Pembrolizumab, Drug: EpacadostatPart 1 is an open-label 3 + 3 + 3 dose-escalation design based on observing each dose level for a period of 42 days. Part 1 will also contain dose-expansion cohorts in previously treated NSCLC and MSS CRC. Part 2 will evaluate the recommended dose determined in Part 1. |
| Treatment Group C: INCB059872 + Pembrolizumab + Epacadostat | Experimental | Drug: Pembrolizumab, Drug: Epacadostat, Drug: INCB059872Part 1 is an open-label 3 + 3 + 3 dose-escalation design based on observing each dose level for a period of 42 days. Part 1 will also contain dose-expansion cohorts in previously treated NSCLC and MSS CRC. Part 2 will evaluate the recommended dose 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 (25 listed)
- Willingness to provide written informed consent for the study.
- Willingness to undergo a pretreatment and on-treatment tumor biopsy to obtain tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Part 1: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject refusal or intolerance is also allowable).
- Part 2:
Key exclusion criteria (14 listed)
- Laboratory parameters not within the protocol-defined range.
- Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
- Has not recovered from toxic effects of prior therapy to ≤ Grade 1.
- Active or inactive autoimmune disease or syndrome.
- Active infection requiring systemic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineFive doses of azacitidine will be administered by subcutaneous injection or intravenously (IV) over Days 1 to 7 in Cycles 1 through 6. | Drug | Treatment Group A: Azacitidine + Pembrolizumab + Epacadostat |
| PembrolizumabPembrolizumab will be administered in a 30-minute IV infusion every 3 weeks on Day 1 of each 21-day cycle. | Drug | Treatment Group A: Azacitidine + Pembrolizumab + Epacadostat |
| EpacadostatEpacadostat tablets will be administered orally twice daily. | Drug | Treatment Group A: Azacitidine + Pembrolizumab + Epacadostat |
| INCB057643INCB057643 will be orally self- administered once daily beginning on Cycle 1 Day 1 and continuously thereafter in 21-day cycles. | Drug | Treatment Group B: INCB057643 + Pembrolizumab + Epacadostat |
| PembrolizumabPembrolizumab will be administered in a 30-minute IV infusion every 3 weeks of each 21-day cycle starting on Cycle 2 Day 1. | Drug | Treatment Group B: INCB057643 + Pembrolizumab + Epacadostat, Treatment Group C: INCB059872 + Pembrolizumab + Epacadostat |
| EpacadostatEpacadostat tablets will be administered orally twice daily starting at Cycle 2 Day 1. | Drug | Treatment Group B: INCB057643 + Pembrolizumab + Epacadostat, Treatment Group C: INCB059872 + Pembrolizumab + Epacadostat |
| INCB059872INCB059872 will be orally self- administered once daily OR every other day beginning on Cycle 1 Day 1 and continuously thereafter in 21-day cycles. | Drug | Treatment Group C: INCB059872 + Pembrolizumab + Epacadostat |
Primary outcome
Part 1 and 2 : Number of Participants With Treatment Emergent Adverse Events
Time frame: Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period).
A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
Part 1 and 2: Objective Response Rate Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Every 9 weeks for the duration of study participation; estimated minimum of 6 months.
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. A participant was considered as an objective responder if the participant had a best overall response of CR or PR.
3 secondary outcomes
Parts 1 and 2: Percentage of Responders Determined by Immunohistochemistry
Time frame: Baseline to Week 5/6 or week 8/9
Parts 1 and 2: Progression-free Survival Based on RECIST v1.1.
Time frame: Every 9 weeks from date of randomization until the date of first documented progression or date of death from any cause whichever came first, assessed up to 24 months
Parts 1 and 2: Duration of Response Based on RECIST v1.1
Time frame: Every 9 weeks from date of randomization until the date of first documented progression or date of death from any cause whichever came first, assessed up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Kevin O'Hayer, MD study director
Incyte Corporation
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Azacitidine, Pembrolizumab and Epacadostat in people with Solid Tumors and Advanced Malignancies, run by Incyte Corporation 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 25 inclusion and 14 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 21 Oct 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, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2020). 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?
Part 1 and 2 : Number of Participants With Treatment Emergent Adverse Events (time frame: Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period).). 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 21 Oct 2025.