Tri-specific Killer EngagerPhase 1NCT07541573
GTB-5550 in Advanced Solid Tumors
A Phase 1 study testing GTB-5550 in people with Tri-specific Killer Engager and Solid Tumor, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a first-in-human Phase 1a/1b trial of a B7-H3-targeted natural killer (NK) cell engager, referred to as a TriSpecific Killer Engager (TriKE), for the treatment of select solid tumor cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tri-specific Killer Engager, Solid Tumor, Advanced Solid Tumor
- What is being tested?
- GTB-5550
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to Jan 2032
- Phase
- Phase 1
- 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
- Measurable disease per RECIST 1.1. (Exception: mCRPC limited to bone metastasis is exempt from this requirement).
- Age 18 years or older at the time of consent, ECOG Performance Status 0 to 2
- Acute effects of any prior therapy must have resolved to baseline or Grade ≤ 1 NCI CTCAE v5 except for AEs not constituting a safety risk in the opinion of the enrolling Investigator.
- Adequate organ function within 14 days (30 days for cardiac) of Cycle 1 Day 1 defined as:
- Hematologic: hemoglobin ≥ 9 g/dL (may be transfused not more than 2 units of pRBCs within 7 days prior to Cycle 1 Day 1 to meet this requirement); absolute neutrophil count (ANC) ≥ 1500/ul (granulocyte colonystimulating factor (s) is not allowed to achieve ANC threshold or within 7 days of Cycle 1 Day 1); platelets ≥ 100 x 10^9/L (may be transfused not more than 2 units of platelets within 7 days prior to Cycle 1 Day 1 to meet this requirement); absolute lymphocyte count (ALC) ≥ 300/ul.
- Albumin ≥ 3.0 g/dL.
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- Renal: a patient BSA corrected glomerular filtration rate ≥ 45 mL/min as calculated using the Modified Cockroft-Gault equation (Rostoker et al. 2007).
- Hepatic: AST and ALT ≤1.5 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN.
- Cardiac: New York Heart Association (NYHA) Class I or II ; left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram, MUGA, or cardiac MRI.
- Adequate pulmonary function with PFTs > 50% FEV1 if symptomatic or known impairment.
- Sexually active couples of childbearing-potential must agree to use effective contraception or abstinence during treatment and for at least 4 months after the final dose of GTB-5550.
- Agrees to stay within a 60-minute drive of the study center through the Cycle 1 Day 15 visit for the Phase 1a study only.
- Provides voluntary written consent prior to the performance of any research related activity
Who cannot join
- Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days prior to the 1st dose of GTB-5550. Radioligand therapy requires at least 1 cycle washout (6 weeks for Pluvicto, 4 weeks for Xofigo).
- Prior organ allograft or allogeneic transplantation. An exception is made for FA patients with prior history of allogeneic hematopoietic stem cell transplant off immune suppressive therapy for > 1 year.
- Pregnant or breastfeeding or planning pregnancy within 4 months after the last dose of GTB-5550.
- The potential risk of QT/QTc prolongation is unknown in humans receiving GTB-5550; therefore, either of the following is an exclusion criteria: QTc interval > 480 msec at screening and/or a family history of long QT syndrome.
- Prior malignancy other than the one under treatment except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer which is currently in complete remission, or any other cancer from which the patient has been disease-free for 1 year after surgical or other definitive treatment.
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 1 year or any other diseases requiring immunosuppressive therapy while on study. Inhaled or topical steroids, and adrenal replacement steroid doses ≤10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
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- Active systemic infection requiring parenteral antibiotic therapy. Any prior systemic infections must have resolved to Grade 1 or lower following optimal therapy.
- Psychiatric illness/social situations that in the judgement of the enrolling investigator would limit compliance with study requirements.
- Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient's participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Nicholas Zorko, MD
About this study
Official title: MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy
This is a first-in-human Phase 1a/1b trial of a B7-H3-targeted natural killer (NK) cell engager, referred to as a TriSpecific Killer Engager (TriKE), for the treatment of select solid tumor cancers. To be considered for the study, a patient must be 18 years or older, have histologically or cytologically confirmed advanced/metastatic cancer that, based on literature reports, expresses B7-H3 at a high frequency, measurable disease by RECIST 1.1 (exception: mCRPC limited to bone metastasis are exempt from this requirement), meets the disease specific criteria for prior failed therapy, and refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit for their diagnosis.
Read the detailed description
Enrollment is limited to the following tumor types:
- castration-resistant prostate cancer (CRPC)
- breast cancer (any ER/PR or HER2 status)
- pancreatic cancer
- non-small cell lung cancer (NSCLC)
- squamous cell carcinoma of the head and neck (SCCHN), including molecularlyconfirmed FA patients
- epithelial ovarian cancer (OC), including fallopian tube and primary peritoneal cancer
- bladder (urothelial) cancer (UC)
- Prostate cancer requires failing at least one line of prior therapy in the castrate resistant setting.
- SCCHN patients with a molecularly-confirmed diagnosis of FA are permitted to enroll on the trial if they have unresectable locally advanced or metastatic SCCHN which is ineligible for or has failed radiation therapy. All other diagnoses require failing at least two lines of prior therapy given either in the recurrent and/or metastatic setting.
The camelid (cam) anti-CD16/WT IL-15/cam anti-B7-H3 Tri-Specific Killer Engager (camB7-H3 TriKE, also referred to as GTB-5550) is a single chain recombinant TriKE comprised of three components joined by flexible linkers to form a molecule: 1) an arm that engages the CD16 activating receptor (cam anti-CD16) on natural killer (NK) cells; 2) a wildtype IL-15 (WT IL-15) linker arm to drive NK cell proliferation, priming, and survival; and 3) an arm that specifically engages B7-H3 (cam anti-B7-H3) to target the tumor cells.
The study is performed in two sequential components as follows:
- Phase 1a: Dose escalation, open-label component testing up to 6 dose levels of GTB-5550 to identify the MTD using an adaptation of the BOIN design starting with 2 patient cohorts.
- Phase 1b: Dose expansion component to confirm the MTD identified in the Phase 1a trial across 7 distinct metastatic disease cohorts (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its tolerability assuming the toxicity rates are similar across the groups.
GTB-5550 is administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days (i.e. Monday-Friday) for Cycle 1 Days 1-5 and Days 8-12, followed by 2 weeks off treatment. Starting with Cycle 2 Day 1 and beyond, treatment will be 3 times 2025LS049: GTB-5550 TriKE® for Select Advanced Solid Tumors That Failed Prior Therapy March 19, 2026 Page 27 of 86 confidential per week (but not on 3 consecutive days) for 2 weeks followed by 2 weeks off treatment.
One treatment cycle equals 4 weeks (28 days).
A minimum of 2 cycles is planned unless medically contraindicated or the participant wishes to discontinue earlier. Patient appropriate disease reassessment is done after 2 cycles (56 days) and every 8 weeks (+/- 1 week) thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months from the 1st dose of GTB-5550 to determine PFS and OS. The primary analysis will be intent-to-treat from the point of 1st injection of GTB-5550 both for toxicity and efficacy.
- Being tested
- GTB-5550
- Keywords
- TriKE, GTB-5550
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTB-5550Drug
Also called Camelid Nanobody B7-H3 Tri-Specific Killer Engager (camB7-H3 TriKE®)
GTB-5550 is given as a subcutaneous (SQ) injection in the abdominal area at the patient-assigned dose once a day for 5 consecutive days for 2 weeks in a row (i.e.
Day 1-5 and Day 8-12) followed by 2 weeks of no treatment. This 4-week period equals 1 treatment cycle, or 28 days. Starting with Cycle 2 and beyond, this will be repeated with three times per week dosing for weeks 1 and 2 of the cycle (but not on 3 consecutive days) followed by 2 weeks of no treatment.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level Cohort -1 | Experimental | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 90 µg (or 20 µL) of GTB-5550. Receives: Drug: GTB-5550 |
| Dose Level Cohort 1 | Experimental | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 270 µg (or 60 µL) of GTB-5550. Receives: Drug: GTB-5550 |
| Dose Level Cohort 2 | Experimental | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 900 µg (or 200 µL) of GTB-5550. Receives: Drug: GTB-5550 |
| Dose Level Cohort 3 | Experimental | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 2700 µg (or 600 µL) of GTB-5550. Receives: Drug: GTB-5550 |
| Dose Level Cohort 4 | Experimental | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 5400 µg (or 1200 µL) of GTB-5550. Receives: Drug: GTB-5550 |
| Dose Level Cohort 5 | Experimental | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 9000 µg (or 2000 µL) of GTB-5550. Receives: Drug: GTB-5550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
The primary objective is to identify one of the six dose-level strategies of GTB-5550 (cam anti-CD16/WT IL 15/cam anti-B7-H3 TriKE) that corresponds to the desired maximum toxicity rate of less of equal to 20%, defining the MTD.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start8 Apr 2026
- Primary completionJan 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tri-specific Killer EngagerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- GT Biopharma, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541573
- Sponsor's protocol ID
- 2025LS049
- Other IDs
- W81XWH-20-1-0659, HT9425-25-1-0438, W81XWH-22-1-0242
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Apr 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy
- ClinicalTrials.gov ID
- NCT07541573
- Acronym / sponsor ID
- 2025LS049
- Keywords
- TriKE, GTB-5550
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- GT Biopharma, Inc.
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human Phase 1a/1b trial of a B7-H3-targeted natural killer (NK) cell engager, referred to as a TriSpecific Killer Engager (TriKE), for the treatment of select solid tumor cancers. To be considered for the study, a patient must be 18 years or older, have histologically or cytologically confirmed advanced/metastatic cancer that, based on literature reports, expresses B7-H3 at a high frequency, measurable disease by RECIST 1.1 (exception: mCRPC limited to bone metastasis are exempt from this requirement), meets the disease specific criteria for prior failed therapy, and refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit for their diagnosis.
Detailed description
Enrollment is limited to the following tumor types:
- castration-resistant prostate cancer (CRPC)
- breast cancer (any ER/PR or HER2 status)
- pancreatic cancer
- non-small cell lung cancer (NSCLC)
- squamous cell carcinoma of the head and neck (SCCHN), including molecularlyconfirmed FA patients
- epithelial ovarian cancer (OC), including fallopian tube and primary peritoneal cancer
- bladder (urothelial) cancer (UC)
- Prostate cancer requires failing at least one line of prior therapy in the castrate resistant setting.
- SCCHN patients with a molecularly-confirmed diagnosis of FA are permitted to enroll on the trial if they have unresectable locally advanced or metastatic SCCHN which is ineligible for or has failed radiation therapy. All other diagnoses require failing at least two lines of prior therapy given either in the recurrent and/or metastatic setting.
The camelid (cam) anti-CD16/WT IL-15/cam anti-B7-H3 Tri-Specific Killer Engager (camB7-H3 TriKE, also referred to as GTB-5550) is a single chain recombinant TriKE comprised of three components joined by flexible linkers to form a molecule: 1) an arm that engages the CD16 activating receptor (cam anti-CD16) on natural killer (NK) cells; 2) a wildtype IL-15 (WT IL-15) linker arm to drive NK cell proliferation, priming, and survival; and 3) an arm that specifically engages B7-H3 (cam anti-B7-H3) to target the tumor cells.
The study is performed in two sequential components as follows:
- Phase 1a: Dose escalation, open-label component testing up to 6 dose levels of GTB-5550 to identify the MTD using an adaptation of the BOIN design starting with 2 patient cohorts.
- Phase 1b: Dose expansion component to confirm the MTD identified in the Phase 1a trial across 7 distinct metastatic disease cohorts (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its tolerability assuming the toxicity rates are similar across the groups.
GTB-5550 is administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days (i.e. Monday-Friday) for Cycle 1 Days 1-5 and Days 8-12, followed by 2 weeks off treatment. Starting with Cycle 2 Day 1 and beyond, treatment will be 3 times 2025LS049: GTB-5550 TriKE® for Select Advanced Solid Tumors That Failed Prior Therapy March 19, 2026 Page 27 of 86 confidential per week (but not on 3 consecutive days) for 2 weeks followed by 2 weeks off treatment.
One treatment cycle equals 4 weeks (28 days).
A minimum of 2 cycles is planned unless medically contraindicated or the participant wishes to discontinue earlier. Patient appropriate disease reassessment is done after 2 cycles (56 days) and every 8 weeks (+/- 1 week) thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months from the 1st dose of GTB-5550 to determine PFS and OS. The primary analysis will be intent-to-treat from the point of 1st injection of GTB-5550 both for toxicity and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Level Cohort -1 | Experimental | Drug: GTB-5550Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 90 µg (or 20 µL) of GTB-5550. |
| Dose Level Cohort 1 | Experimental | Drug: GTB-5550Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 270 µg (or 60 µL) of GTB-5550. |
| Dose Level Cohort 2 | Experimental | Drug: GTB-5550Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 900 µg (or 200 µL) of GTB-5550. |
| Dose Level Cohort 3 | Experimental | Drug: GTB-5550Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 2700 µg (or 600 µL) of GTB-5550. |
| Dose Level Cohort 4 | Experimental | Drug: GTB-5550Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 5400 µg (or 1200 µL) of GTB-5550. |
| Dose Level Cohort 5 | Experimental | Drug: GTB-5550Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 9000 µg (or 2000 µL) of GTB-5550. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Measurable disease per RECIST 1.1. (Exception: mCRPC limited to bone metastasis is exempt from this requirement).
- Age 18 years or older at the time of consent, ECOG Performance Status 0 to 2
- Acute effects of any prior therapy must have resolved to baseline or Grade ≤ 1 NCI CTCAE v5 except for AEs not constituting a safety risk in the opinion of the enrolling Investigator.
- Adequate organ function within 14 days (30 days for cardiac) of Cycle 1 Day 1 defined as:
- Hematologic: hemoglobin ≥ 9 g/dL (may be transfused not more than 2 units of pRBCs within 7 days prior to Cycle 1 Day 1 to meet this requirement); absolute neutrophil count (ANC) ≥ 1500/ul (granulocyte colonystimulating factor (s) is not allowed to achieve ANC threshold or within 7 days of Cycle 1 Day 1); platelets ≥ 100 x 10^9/L (may be transfused not more than 2 units of platelets within 7 days prior to Cycle 1 Day 1 to meet this requirement); absolute lymphocyte count (ALC) ≥ 300/ul.
Key exclusion criteria (9 listed)
- Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days prior to the 1st dose of GTB-5550. Radioligand therapy requires at least 1 cycle washout (6 weeks for Pluvicto, 4 weeks for Xofigo).
- Prior organ allograft or allogeneic transplantation. An exception is made for FA patients with prior history of allogeneic hematopoietic stem cell transplant off immune suppressive therapy for > 1 year.
- Pregnant or breastfeeding or planning pregnancy within 4 months after the last dose of GTB-5550.
- The potential risk of QT/QTc prolongation is unknown in humans receiving GTB-5550; therefore, either of the following is an exclusion criteria: QTc interval > 480 msec at screening and/or a family history of long QT syndrome.
- Prior malignancy other than the one under treatment except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer which is currently in complete remission, or any other cancer from which the patient has been disease-free for 1 year after surgical or other definitive treatment.
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 |
|---|---|---|
| GTB-5550Also: Camelid Nanobody B7-H3 Tri-Specific Killer Engager (camB7-H3 TriKE®)GTB-5550 is given as a subcutaneous (SQ) injection in the abdominal area at the patient-assigned dose once a day for 5 consecutive days for 2 weeks in a row (i.e. Day 1-5 and Day 8-12) followed by 2 weeks of no treatment. This 4-week period equals 1 treatment cycle, or 28 days. Starting with Cycle 2 and beyond, this will be repeated with three times per week dosing for weeks 1 and 2 of the cycle (but not on 3 consecutive days) followed by 2 weeks of no treatment. | Drug | Dose Level Cohort -1, Dose Level Cohort 1, Dose Level Cohort 2, Dose Level Cohort 3, Dose Level Cohort 4, Dose Level Cohort 5 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 1 year
The primary objective is to identify one of the six dose-level strategies of GTB-5550 (cam anti-CD16/WT IL 15/cam anti-B7-H3 TriKE) that corresponds to the desired maximum toxicity rate of less of equal to 20%, defining the MTD.
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 23 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GTB-5550 in people with Tri-specific Killer Engager and Solid Tumor, run by Masonic Cancer Center, University of Minnesota 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 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Zorko, MD (612-625-3051, zorko004@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: 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 23 Apr 2026.