Endometrial CancerPhase 2NCT05761951
Phase 2 Study Evaluating the Efficacy of the Combination of DKN-01 (DKK1 Inhibitor, Leap Therapeutics) and Pembrolizumab in the Treatment of Advanced or Recurrent Endometrial Cancer
A Phase 2 study testing DKN-01 and Pembrolizumab in people with Endometrial Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if the combination of DKN-01 and pembrolizumab can help to control advanced or recurrent endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- DKN-01 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2023to 31 Jan 2029
- 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
- Written informed consent and any locally-required authorization (e.g., HIPAA in the USA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Female participants age ≥ 18 years at the time of signing informed consent.
- Must have histologically confirmed diagnosis of advanced or recurrent endometrioid endometrial cancer that is deemed non-curable with either surgery or radiation therapy. Mixed endometrioid patient will be allowed if the endometrioid component is greater than 50% of the tumor and does not include serous or carcinosarcoma. Non-endometrioid endometrial cancer must have a confirmed Wnt-activating mutation (CTNNB1, RNF-43, APC, AXIN1/2, RSPO2/3, and ZNRF3).
- Patients may have received up to 2 prior systemic therapies for recurrent disease. Note: Chemotherapy given in conjunction with radiation or as part of primary therapy does not count as prior systemic therapy for recurrence. Hormonal therapy does not count toward prior therapy.
- Must consent to allow for a pre-treatment tumor biopsy. Tumor material from biopsies done before the screening period are acceptable if the biopsy was performed within 3 months prior to the planned treatment start and no other systemic cancer therapy was administered in the interim. If a biopsy is performed as part of the study and the specimen is considered non-diagnostic or does not have enough tissue (occurs less than 10% of the time), archival tissue can be used to determine the study cohort and the patient can still participate in the trial.
- Must not have received/progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
Show all 23Show fewer
- Patients must be off all other anti-tumor therapies (including immunologic agents) for at least four weeks prior to start of treatment. Patients on hormonal agents require a washout for 10 days
- Patients must be off all other anti-tumor therapies (including immunologic agents) for at least four weeks prior to study registration. Patients on hormonal agents require a washout for 10 days
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- Women of childbearing potential (WoCBP) must be permanently or surgically sterilized (undergone a total hysterectomy, bilateral lubal tigation, or bilateral oophorectomy) or are postmenopausal for greater than 12 months. (If uncertain of amenorrhea for 12 months, a pregnancy test will be done to confirm pregnancy status.) If ovaries are present and were not previously menopausal at the time of hysterectomy, should have a serum estradiol <10 pm/mL to confirm ovarian senescence.
- Adequate hematological organ function laboratory values are defined below:
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100 000/µL
- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La
- Adequate renal organ function laboratory values are defined below:
- Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) of ≤1.5 × ULN OR
- ≥30 mL/min with creatinine levels >1.5 × institutional ULN
- Adequate hepatic organ function laboratory values are defined below:
- Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
- AST (SGOT) and ALT (SGPT) ≤2.5 × ULN unless liver metastasis are present, in which case it must be ≤5 × ULN
- Adequate coagulation function laboratory values of international normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) of ≤1.5 × ULN receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
- Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
- Creatinine clearance (CrCl) should be calculated per institutional standard. Laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.
Who cannot join
- Have uterine sarcomas, carcinosarcomas, serous tumors (any component) or pure clear cell carcinomas without documentation of a Wnt-activating mutation (see Figure 2 for definition)
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Previously treated with an anti-DKK1 therapy.
- Has deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) are excluded.
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment.
- Patient has not recovered from all toxicities related to prior anticancer therapies to NCI-CTCAEv5.0 Grade <1 (Exception to this criterion: any grade of alopecia is eligible for the study).
Show all 29Show fewer
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Major surgical procedures, open biopsy or significant traumatic injury within 4 weeks prior to treatment start (minor procedures within 1 week)
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. (Note: Administration of killed vaccines is allowed.)
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are eligible.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging. Note: repeat imaging should be performed during study screening. Participants must be clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has known history of human immunodeficiency virus (HIV) unless patient meets the following criteria:
- HIV RNA is undetected
- Have hepatitis B surface antigen
- Have hepatitis C antibodies unless hepatitis C virus ribonucleic acid (RNA) is undetected/negative).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has had an allogenic tissue/solid organ transplant.
- Has New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
- Have Fridericia-corrected QT interval (QTcF) >470 msec, or history of congenital long QT syndrome. Any ECG abnormality that in the opinion of the Investigator would preclude safe participation in the study; patients with pacemakers where QTc is not a reliable measure will require an evaluation by a cardiologist to exclude co-existing cardiac conditions which would prohibit safe participation in the study.
- History of osteonecrosis of the hip or evidence of structural bone abnormalities in the proximal femur on magnetic resonance imaging (MRI) scan that are symptomatic and clinically significant. Degenerative changes of the hip joint are not exclusionary. Screening of asymptomatic patients is not required.
- Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
- Women of childbearing potential (WoCBP) or who are pregnant or breastfeeding are excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
To learn if the combination of DKN-01 and pembrolizumab can help to control advanced or recurrent endometrial cancer.
Read the detailed description
Primary Objective:
--The primary objective is to determine the efficacy (objective response rate, ORR) of the combination of DKN-01 and pembrolizumab in the treatment of women with advanced, recurrent endometrioid endometrial cancer or non-endometrioid endometrial cancer with a Wnt/ β-catenin activating mutation.
Secondary Objective:
--Estimate clinical benefit, progression-free survival, overall survival, and duration of response in patients with recurrent or progressive EC treated with DKN-01/ Pembrolizumab. To assess the tolerability of the combination.
Exploratory Objective:
- We will perform the following translational studies to determine the correlation between molecular characteristics and likelihood of response to therapy. The six-month progression free survival (PFS) and the median survival from time of study entry (first treatment) to progression (PFS) or death (OS) will be estimated.
- Determine if DKK1 over-expression, using RNAscope in situ hybridization performed in a central lab, is associated with CTNNB1 mutation or mutation in other genes associated with Wnt/β-catenin pathway activation. High expression of DKK1 is defined as greater than 10% positive cells on RNAscope.
- Determine if mutation status of CTNNB1 or other genes known to result in activation of WNT/β-catenin signaling, such as RNF-43, APC, AXIN1/2, RSPO2/3, and ZNRF3 [1], correlate to response to the combination in women with advanced or recurrent EC. Mutation status of these genes will be determined by next-generation sequencing (Oncomine, ThermoFisher) in a CLIA- and CAP-approved Molecular Diagnostics Laboratory in the Division of Pathology \& Laboratory Medicine, MD Anderson Cancer Center using formalin-fixed, paraffin-embedded tissues OR other commercially available, CLIA-certified platforms including but not limited to FoundationOne, Tempus, or CARIS. The presence of a mutation in any of these genes will be considered as indicative of Wnt/β-catenin pathway activation in a patient's tumor. Mutation status will be correlated with treatment response. Mutation status will be correlated with tumoral DKK1 expression. NGS will be performed on baseline biopsies of metastatic disease at the time of enrollment, when available, or using the primary tumor from the hysterectomy if tissue cannot be obtained or is inadequate for testing.
- Determine optimal threshold of DKK1 expression and correlation to treatment response to DKN-01 and pembrolizumab.
- Determine if IHC nuclear localization of mutant β-catenin correlates to treatment response to DKN-01 and pembrolizumab.
- Determine if IHC CD73 expression levels correlate to treatment response to DKN-01 and pembrolizumab.
- Determine if PD-L1 IHC levels correlate to treatment response.
- Determine if additional genetics by NGS including but not limited to PIK3CA mutations and TMB correlate to treatment response
- Determine if blood-based protein markers including but not limited to cytokines at baseline and changes on treatment correlate to response
- Conditions
- Endometrial Cancer
- Being tested
- DKN-01, Pembrolizumab
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKN-01Drug
Given by IV (vein)
PembrolizumabDrug
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| DKN-01 | Experimental | Participants will receive DKN-01 by vein over about 30 minutes to 2 hours on Day 1 of each cycle, as well ason Day 15 of Cycle 1. Receives: Drug: DKN-01; Drug: Pembrolizumab |
| Pembrolizumab | Experimental | Participants will receive pembrolizumab by vein over about 30 minutes on Day 1 of each cycle for up to 24 months. Receives: Drug: DKN-01; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start29 Aug 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Leap Therapeutics, Inc., Merck Sharp & Dohme LLC, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Pamela Soliman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761951
- Sponsor's protocol ID
- 2022-0526
- Other IDs
- NCI-2023-01855
- Status last verified
- May 2026
- First submitted
- 27 Feb 2023
- Last updated
- 19 May 2026
- Results posted
- No
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Evaluating the Efficacy of the Combination of DKN-01 (DKK1 Inhibitor, Leap Therapeutics) and Pembrolizumab in the Treatment of Advanced or Recurrent Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05761951
- Acronym / sponsor ID
- 2022-0526
- Conditions
- Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Leap Therapeutics, Inc., Merck Sharp & Dohme LLC, National Cancer Institute (NCI)
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 9 Mar 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.
To learn if the combination of DKN-01 and pembrolizumab can help to control advanced or recurrent endometrial cancer.
Detailed description
Primary Objective:
--The primary objective is to determine the efficacy (objective response rate, ORR) of the combination of DKN-01 and pembrolizumab in the treatment of women with advanced, recurrent endometrioid endometrial cancer or non-endometrioid endometrial cancer with a Wnt/ β-catenin activating mutation.
Secondary Objective:
--Estimate clinical benefit, progression-free survival, overall survival, and duration of response in patients with recurrent or progressive EC treated with DKN-01/ Pembrolizumab. To assess the tolerability of the combination.
Exploratory Objective:
- We will perform the following translational studies to determine the correlation between molecular characteristics and likelihood of response to therapy. The six-month progression free survival (PFS) and the median survival from time of study entry (first treatment) to progression (PFS) or death (OS) will be estimated.
- Determine if DKK1 over-expression, using RNAscope in situ hybridization performed in a central lab, is associated with CTNNB1 mutation or mutation in other genes associated with Wnt/β-catenin pathway activation. High expression of DKK1 is defined as greater than 10% positive cells on RNAscope.
- Determine if mutation status of CTNNB1 or other genes known to result in activation of WNT/β-catenin signaling, such as RNF-43, APC, AXIN1/2, RSPO2/3, and ZNRF3 [1], correlate to response to the combination in women with advanced or recurrent EC. Mutation status of these genes will be determined by next-generation sequencing (Oncomine, ThermoFisher) in a CLIA- and CAP-approved Molecular Diagnostics Laboratory in the Division of Pathology \& Laboratory Medicine, MD Anderson Cancer Center using formalin-fixed, paraffin-embedded tissues OR other commercially available, CLIA-certified platforms including but not limited to FoundationOne, Tempus, or CARIS. The presence of a mutation in any of these genes will be considered as indicative of Wnt/β-catenin pathway activation in a patient's tumor. Mutation status will be correlated with treatment response. Mutation status will be correlated with tumoral DKK1 expression. NGS will be performed on baseline biopsies of metastatic disease at the time of enrollment, when available, or using the primary tumor from the hysterectomy if tissue cannot be obtained or is inadequate for testing.
- Determine optimal threshold of DKK1 expression and correlation to treatment response to DKN-01 and pembrolizumab.
- Determine if IHC nuclear localization of mutant β-catenin correlates to treatment response to DKN-01 and pembrolizumab.
- Determine if IHC CD73 expression levels correlate to treatment response to DKN-01 and pembrolizumab.
- Determine if PD-L1 IHC levels correlate to treatment response.
- Determine if additional genetics by NGS including but not limited to PIK3CA mutations and TMB correlate to treatment response
- Determine if blood-based protein markers including but not limited to cytokines at baseline and changes on treatment correlate to response
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DKN-01 | Experimental | Drug: DKN-01, Drug: PembrolizumabParticipants will receive DKN-01 by vein over about 30 minutes to 2 hours on Day 1 of each cycle, as well ason Day 15 of Cycle 1. |
| Pembrolizumab | Experimental | Drug: DKN-01, Drug: PembrolizumabParticipants will receive pembrolizumab by vein over about 30 minutes on Day 1 of each cycle for up to 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Written informed consent and any locally-required authorization (e.g., HIPAA in the USA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Female participants age ≥ 18 years at the time of signing informed consent.
- Must have histologically confirmed diagnosis of advanced or recurrent endometrioid endometrial cancer that is deemed non-curable with either surgery or radiation therapy. Mixed endometrioid patient will be allowed if the endometrioid component is greater than 50% of the tumor and does not include serous or carcinosarcoma. Non-endometrioid endometrial cancer must have a confirmed Wnt-activating mutation (CTNNB1, RNF-43, APC, AXIN1/2, RSPO2/3, and ZNRF3).
- Patients may have received up to 2 prior systemic therapies for recurrent disease. Note: Chemotherapy given in conjunction with radiation or as part of primary therapy does not count as prior systemic therapy for recurrence. Hormonal therapy does not count toward prior therapy.
- Must consent to allow for a pre-treatment tumor biopsy. Tumor material from biopsies done before the screening period are acceptable if the biopsy was performed within 3 months prior to the planned treatment start and no other systemic cancer therapy was administered in the interim. If a biopsy is performed as part of the study and the specimen is considered non-diagnostic or does not have enough tissue (occurs less than 10% of the time), archival tissue can be used to determine the study cohort and the patient can still participate in the trial.
Key exclusion criteria (29 listed)
- Have uterine sarcomas, carcinosarcomas, serous tumors (any component) or pure clear cell carcinomas without documentation of a Wnt-activating mutation (see Figure 2 for definition)
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Previously treated with an anti-DKK1 therapy.
- Has deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) are excluded.
- Has received prior systemic anti-cancer therapy including investigational agents within 4 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 |
|---|---|---|
| DKN-01Given by IV (vein) | Drug | DKN-01, Pembrolizumab |
| PembrolizumabGiven by IV (vein) | Drug | DKN-01, Pembrolizumab |
Primary outcome
). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year.
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 19 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
Related trials for Endometrial Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingPhase 3
Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer
Endometrial Neoplasms, Endometrial Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
Pamela Soliman, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DKN-01 and Pembrolizumab in people with Endometrial Cancer, run by M.D. Anderson Cancer Center 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 23 inclusion and 29 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 19 May 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. 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?
). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year.). 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 19 May 2026.