GlioblastomaPhase 1/2NCT05635734
Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma
A Phase 1/2 study testing Azeliragon 5 mg, Azeliragon 10 mg and Azeliragon 20 mg in people with Glioblastoma, run by Cantex Pharmaceuticals at 4 sites in Spain.
Trial summary
This is an open label study to determine the safety and preliminary evidence of a therapeutic effect of azeliragon in patients with newly diagnosed glioblastoma receiving concurrent radiation and temozolomide. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Azeliragon 5 mg, Azeliragon 10 mg and Azeliragon 20 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 4 sitesSpain
- Study dates
- 5 Sep 2023to 30 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have histologically confirmed newly diagnosed glioblastoma (GBM, world health organization (WHO) grade IV). The histological diagnosis must have been made after biopsy or neurosurgical tumor resection.
- Note: Patients should be isocitrate dehydrogenase (IDH) wild type diagnosed locally
- The local O-6-Methylguanine-DNA Methyltransferase (MGMT) report determination should be available and should be uploaded to the electronic case report form (eCRF).
- Patient should have had a gross total or subtotal resection performed < 7 weeks prior to enrollment, documented at postoperative MRI. Patients who have had a biopsy only without resection are not eligible.
- Patient deemed suitable by the treating physician to receive the standard radiotherapy regimen in combination with temozolomide.
- Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 70 years of age.
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- Patient may have received and continue to receive corticosteroids, but must be on a stable or decreasing dose for at least 14 days prior to first dose of study treatment.
- Patient has not received prior chemotherapy or radiotherapy.
- Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0: Absolute neutrophil count (ANC) ≥ 1.0 × 109/L; Platelet count ≥ 75,000/mm3 (75 × 109/L); Hemoglobin (Hgb) ≥ 9 g/dL without transfusion or growth factor support
- Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0:
- aspartate amino-transferase (AST)(SGOT), alanine transferase (ALT)(SGPT) ≤ 2.5 × upper limit of normal range (ULN). Total bilirubin ≤ 1.5 × ULN.
- Estimated creatinine clearance of > 60 mL/min (per Cockcroft -Gault formula)
- Patients with a QTC of ≤ 480 msec
- Patient has ECOG performance status of ≤ 2
- Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
Who cannot join
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 5 years
- Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) at the time of inclusion or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment
- Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
- Patients who have had treatment with any investigational cancer drug prior to the first dose of study treatment.
- Patient has experienced an increase of ECOG to > 2 between Screening and the time of first dose with azeliragon.
- Patients receiving CYP2C8 inhibitors
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- Patient is unwilling or unable to comply with study procedures, including, but not limited to self-administration of oral medication.
- Patients with a gastrointestinal condition that could interfere with swallowing or absorption.
- Females of childbearing potential who are sexually active or males with female partners of childbearing potential, where either the female or the male is unwilling to use a highly effective method of contraception during the trial and for 6 months after the last administration of azeliragon.
- Patients with concurrent participation in another interventional clinical trial or use of another investigational agent within 14 days of starting azeliragon. Patients who are participating in non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
About this study
Official title: A Phase I/II Open Label Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined With Conventional Concurrent Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma
This is an open label study to determine the safety and preliminary evidence of a therapeutic effect of azeliragon in patients with newly diagnosed glioblastoma receiving concurrent radiation and temozolomide.
Read the detailed description
Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles.
Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.
Patients will be accrued in groups of six starting with Dose Level 1. Escalation will continue as described in Table 2 until stopping rules are met or the highest defined dose level is reached. If Dose Level 1 is deemed intolerable, the trial will be closed to accrual.
The dose limiting toxicities (DLT) evaluation period will be defined as 28 days from initiation of dosing. The severity of adverse events will be graded according to CTCAE v 5.0. For the purpose of dose-finding, any listed AEs occurring during the DLT period, which are attributable (definite, probable, possible) to azeliragon will be classified as a DLT. In addition, the RP2/3D will take into account dose-reductions, treatment interruptions, discontinuation, and toxicities after the DLT period.
RP2/3D was defined as the dose with 6 patients treated at that dose level with ≤ 1 DLT observed.
- Conditions
- Glioblastoma
- Being tested
- Azeliragon 5 mg, Azeliragon 10 mg, Azeliragon 20 mg
- Keywords
- Azeliragon, Newly diagnosed glioblastoma, Dose finding, Temozolomide, Radiotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azeliragon 5 mgDrug
Azeliragon 5 mg once a day (loading initial dose for 6 days of 10 mg daily). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.
Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles.
Azeliragon 10 mgDrug
Azeliragon 10 mg once a day (loading initial dose for 6 days of 15 mg twice a day). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.
Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles.
Azeliragon 20 mgDrug
Azeliragon 20 mg once a day (loading initial dose for 6 days of 30 mg twice a day). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.
Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.
Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles. Receives: Drug: Azeliragon 5 mg; Drug: Azeliragon 10 mg; Drug: Azeliragon 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase 2/3 dose
To assess the recommended phase 2/3 dose (RP2/3D) in mg/day of azeliragon in patients with newly diagnosed glioblastoma receiving concurrent radiation and temozolomide.
Dose limiting toxicities were defined as listed AEs, dose-reductions, treatment interruptions, or discontinuation occurring during the DLT period (28 days), which are attributable (definite, probable, possible) to azeliragon will be classified as a DLT. 6 patients must be treated at that dose level with ≤ 1 DLT observed
Measured: Throughout the DLT observation period, approximately 28 days per patient
Secondary outcomes (7)
Incidence of adverse events (AEs)
Percentage of patients experiencing an adverse event
Measured: Throughout the study period, approximately 2 years per patient
Incidence of serious adverse events (SAEs)
Percentage of patients experiencing a serious adverse event
Measured: Throughout the study period, approximately 2 years per patient
Disease control rate (DCR)
Percentage of patients who experience a complete response, partial response or stable disease according to Response Assessment in Neuro-Oncology (RANO) criteria as their best response throughout the study
Measured: Throughout the study period, approximately 2 years per patient
Progression-free survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first
Measured: Throughout the study period, approximately 2 years per patient
Overall survival (OS)
Defined as the duration of time from start of treatment to time of death
Measured: Throughout the study period, approximately 2 years per patient
Patients with changes in the Eastern Cooperative Oncology Group (ECOG) performance status
Percentage of patients who experience a change in ECOG status through the study
Measured: Throughout the study period, approximately 2 years per patient
S100A9 expression levels
Expression levels of the S100A9 molecular biomarker in blood samples from patients. Samples will be taken at baseline, Week 10 and after progression
Measured: Throughout the study period, approximately 2 years per patient in 3 occasions for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start5 Sep 2023
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Sepúlveda, Study chair, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635734
- Sponsor's protocol ID
- CAN 201
- Other IDs
- 2022-002801-36
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) anonymized could be shared upon request if the use is within the scope and protection level authorized by the patients by the signature of the informed consent
Publications
Comitre-Mariano B, Segura-Collar B, Vellila-Alonso G, Contreras R, Hernandez-Lain A, Valiente M, Sepulveda JM, Marcus SG, Garcia-Posadas G, Jimenez-Roldan L, Perez-Nunez A, Gargini R. S100A proteins show a spatial distribution of inflammation associated with the glioblastoma microenvironment architecture. Theranostics. 2025 Jan 1;15(2):726-744. doi: 10.7150/thno.100638. eCollection 2025.
PubMed 39744679
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open Label Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined With Conventional Concurrent Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT05635734
- Acronym / sponsor ID
- CAN 201
- Conditions
- Glioblastoma
- Keywords
- Azeliragon, Newly diagnosed glioblastoma, Dose finding, Temozolomide, Radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cantex PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 2 Dec 2022 (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 an open label study to determine the safety and preliminary evidence of a therapeutic effect of azeliragon in patients with newly diagnosed glioblastoma receiving concurrent radiation and temozolomide.
Detailed description
Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles.
Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.
Patients will be accrued in groups of six starting with Dose Level 1. Escalation will continue as described in Table 2 until stopping rules are met or the highest defined dose level is reached. If Dose Level 1 is deemed intolerable, the trial will be closed to accrual.
The dose limiting toxicities (DLT) evaluation period will be defined as 28 days from initiation of dosing. The severity of adverse events will be graded according to CTCAE v 5.0. For the purpose of dose-finding, any listed AEs occurring during the DLT period, which are attributable (definite, probable, possible) to azeliragon will be classified as a DLT. In addition, the RP2/3D will take into account dose-reductions, treatment interruptions, discontinuation, and toxicities after the DLT period.
RP2/3D was defined as the dose with 6 patients treated at that dose level with ≤ 1 DLT observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Azeliragon 5 mg, Drug: Azeliragon 10 mg, Drug: Azeliragon 20 mgPatients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible. Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient must have histologically confirmed newly diagnosed glioblastoma (GBM, world health organization (WHO) grade IV). The histological diagnosis must have been made after biopsy or neurosurgical tumor resection.
- Note: Patients should be isocitrate dehydrogenase (IDH) wild type diagnosed locally
- The local O-6-Methylguanine-DNA Methyltransferase (MGMT) report determination should be available and should be uploaded to the electronic case report form (eCRF).
- Patient should have had a gross total or subtotal resection performed < 7 weeks prior to enrollment, documented at postoperative MRI. Patients who have had a biopsy only without resection are not eligible.
- Patient deemed suitable by the treating physician to receive the standard radiotherapy regimen in combination with temozolomide.
Key exclusion criteria (10 listed)
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 5 years
- Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) at the time of inclusion or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment
- Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
- Patients who have had treatment with any investigational cancer drug prior to the first dose of study treatment.
- Patient has experienced an increase of ECOG to > 2 between Screening and the time of first dose with azeliragon.
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 |
|---|---|---|
| Azeliragon 5 mgAzeliragon 5 mg once a day (loading initial dose for 6 days of 10 mg daily). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible. Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles. | Drug | Experimental arm |
| Azeliragon 10 mgAzeliragon 10 mg once a day (loading initial dose for 6 days of 15 mg twice a day). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible. Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles. | Drug | Experimental arm |
| Azeliragon 20 mgAzeliragon 20 mg once a day (loading initial dose for 6 days of 30 mg twice a day). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible. Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles. | Drug | Experimental arm |
Primary outcome
Recommended phase 2/3 dose
Time frame: Throughout the DLT observation period, approximately 28 days per patient
To assess the recommended phase 2/3 dose (RP2/3D) in mg/day of azeliragon in patients with newly diagnosed glioblastoma receiving concurrent radiation and temozolomide. Dose limiting toxicities were defined as listed AEs, dose-reductions, treatment interruptions, or discontinuation occurring during the DLT period (28 days), which are attributable (definite, probable, possible) to azeliragon will be classified as a DLT. 6 patients must be treated at that dose level with ≤ 1 DLT observed
7 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Throughout the study period, approximately 2 years per patient
Incidence of serious adverse events (SAEs)
Time frame: Throughout the study period, approximately 2 years per patient
Disease control rate (DCR)
Time frame: Throughout the study period, approximately 2 years per patient
Progression-free survival (PFS)
Time frame: Throughout the study period, approximately 2 years per patient
Overall survival (OS)
Time frame: Throughout the study period, approximately 2 years per patient
Patients with changes in the Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: Throughout the study period, approximately 2 years per patient
S100A9 expression levels
Time frame: Throughout the study period, approximately 2 years per patient in 3 occasions for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 39744679Comitre-Mariano B, Segura-Collar B, Vellila-Alonso G, Contreras R, Hernandez-Lain A, Valiente M, Sepulveda JM, Marcus SG, Garcia-Posadas G, Jimenez-Roldan L, Perez-Nunez A, Gargini R. S100A proteins show a spatial distribution of inflammation associated with the glioblastoma microenvironment architecture. Theranostics. 2025 Jan 1;15(2):726-744. doi: 10.7150/thno.100638. eCollection 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) anonymized could be shared upon request if the use is within the scope and protection level authorized by the patients by the signature of the informed consent
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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.
Juan Sepúlveda study chair
Hospital Universitario 12 de Octubre
4 sites 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 Azeliragon 5 mg, Azeliragon 10 mg and Azeliragon 20 mg in people with Glioblastoma, run by Cantex Pharmaceuticals at 4 sites in Spain.
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 15 inclusion and 10 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: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recommended phase 2/3 dose (time frame: Throughout the DLT observation period, approximately 28 days per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05635734, which also lists 1 linked publication.
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 Oct 2026.