Advanced Solid TumorPhase 1MYTHICNCT04855656
Study of Lunresertib Alone or in Combination With RP-3500 or Zedoresertib (Debio 0123) in Patients With Advanced Solid Tumors
A Phase 1 study testing Lunresertib, RP-3500 and Zedoresertib in people with Advanced Solid Tumor, run by Debiopharm International SA at 26 sites in 5 countries.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with zedoresertib in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Lunresertib, RP-3500 and Zedoresertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 30 Apr 2021to Jun 2028
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female and ≥12 years-of-age at the time of informed consent.
- Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients >16 years of age.
- Locally advanced or metastatic resistant or refractory solid tumors.
- Patients <18 years of age must weigh at least 40 kg.
- Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible
- Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker.
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- CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH
- FBXW7 deleterious mutations identified by either a tumor or plasma NGS test
- PPP2R1A deleterious mutations identified by either a tumor or plasma NGS test
- Measurable disease as per RECIST v1.1. For certain modules, patients with prostate cancer or ovarian cancer that have non-measurable disease but have elevated tumor markers (PSA or CA-125, respectively) can also be eligible
- Ability to swallow and retain oral medications.
- Acceptable hematologic and organ function at screening.
- Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.
- Resolution of all toxicities of prior therapy or surgical procedures.
- Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment.
Who cannot join
- Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-lives, whichever is shorter, prior to first dose of study drug.
- History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.
- Patients who are pregnant or breastfeeding.
- Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
- Major surgery within 4 weeks prior to first dose of lunresertib.
- Uncontrolled, symptomatic brain metastases.
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- Uncontrolled hypertension.
- Certain prior anti-cancer therapy
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
Trial locations and contacts
26 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 5 countries
United States17 sites, 14 recruiting
- Recruiting
#1002, Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
#1027, University of Virginia
Charlottesville, Virginia, 22903
- Recruiting
#1023, START Midwest
Grand Rapids, Michigan, 49503
- Recruiting
#1001, The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
#1017, Mayo Clinic
Jacksonville, Florida, 32224
- Completed
# 1019, UCLA, Westwood Cancer Center
Los Angeles, California, 90095
- Recruiting
#1012, Yale
New Haven, Connecticut, 06520
- Recruiting
#1032, Northwell Health Cancer Institute
New Hyde Park, New York, 11042
- Completed
#1008, Columbia University
New York, New York, 10032
- Recruiting
#1004, Memorial Sloan Kettering Cancer Institute
New York, New York, 10065
- Completed
#1010, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
#1007, Rhode Island Hospital
Providence, Rhode Island, 02903
- Recruiting
#1030, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02903
- Recruiting
#1016, Mayo Clinic
Rochester, Minnesota, 55902
- Recruiting
#1013, The University of Utah
Salt Lake City, Utah, 84112
- Recruiting
#1025, University of California San Francisco
San Francisco, California, 94158
- Recruiting
#1011, Washington University
St Louis, Missouri, 63130
Spain4 sites, 4 recruiting
- Not yet recruiting
Clinica Universidad de Navarra
Madrid, 28027
- Recruiting
START Madrid. Hospital Fundación Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
- Not yet recruiting
Clinica Universidad de Navarra
Navarra, 31008
Canada3 sites, 1 recruiting
- Completed
#2003, The Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
- Completed
#2002, The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
- Recruiting
#2001, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
Denmark1 site, 1 recruiting
- Recruiting
#4001, Rigshospitalet - Blegdamsvej
Copenhagen
United Kingdom1 site, 1 recruiting
- Recruiting
#3003, Sarah Cannon Research Institute
London, W1G 6AD
About this study
Official title: Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with zedoresertib in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
Read the detailed description
Phase 1/1b, multi-center, open-label, dose-escalation study to:
- Evaluate the safety profile and MTD of lunresertib alone and in combination with RP-3500 or in combination with zedoresertib when administered orally to establish the recommended Phase 2 dose and schedule
- Characterize the PK and pharmacodynamics of lunresertib alone and in combination with RP-3500 or in combination with zedoresertib
- Assess preliminary anti-tumor activity associated with lunresertib alone and in combination with RP-3500 or in combination with zedoresertib
This study was previously posted by Repare Therapeutics. In September 2025, sponsorship of the trial was transferred to Debiopharm International S.A
Expanded Access Status: There is no expanded access program available for the investigational products in this study at this time.
- Conditions
- Advanced Solid Tumor
- Being tested
- Lunresertib, RP-3500, Zedoresertib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LunresertibDrug
Oral PKMYT1 Inhibitor
RP-3500Drug
Oral ATR Inhibitor
ZedoresertibDrug
Also called Debio 0123
Oral WEE1 Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Lunresertib Single-Agent, Dose Escalation and Food-effect Study | Experimental | Patients receive lunresertib orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified. Receives: Drug: Lunresertib |
| Phase 1: Lunresertib in combination with RP-3500, Dose Escalation Study | Experimental | Patients receive lunresertib with RP-3500 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified. Receives: Drug: Lunresertib; Drug: RP-3500 |
| Phase 1: Lunresertib in combination with Zedoresertib, Dose Escalation Study | Experimental | Patients receive lunresertib with zedoresertib orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified. Receives: Drug: Lunresertib; Drug: Zedoresertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of lunresertib either in monotherapy or in combination with RP-3500 or with Zedoresertib in patients with eligible advanced solid tumors
Assessed by treatment-emergent adverse events (TEAEs), physical examinations (PEs), safety laboratory assessments, electrocardiograms (ECGs), and vital sign measurements
Measured: Up to 90 days after last administration of study intervention
To define the MTD of lunresertib monotherapy, and determine a recommended Phase 2 dose (RP2D) and preferred schedule
Assessed by the incidence of Dose-limiting toxicities (DLTs) and the incidence and severity of cumulative safety data
Measured: Up to 90 days after last administration of study intervention
To define the MTD of lunresertib in combination with RP-3500 or in combination with Zedoresertib, and determine a recommended Phase 2 dose (RP2D) and preferred schedule
Assessed by the incidence of dose-limiting toxicities (DLTs) and the incidence and severity of cumulative safety data
Measured: Up to 90 days after last administration of study intervention
The relative bioavailability of lunresertib capsule formulation as compared to lunresertib tablet formulation in the fasted state
Assessed by the plasma concentrations of lunresertib with calculation of pharmacokinetic (PK) parameters including maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), area under the plasma concentration-time curve (AUC) , for both formulations in the fasted state.
Measured: Time 0 (time of dosing) to 72 hours post-dose for each treatment condition
The effect of food on the PK of tablet formulation of lunresertib when administered in fed conditions compared to administration under fasted conditions
Assessed by the plasma concentrations of lunresertib with calculation of the ratio of PK parameters (e.g., Cmax and AUC) between the tablet formulation under fasted and fed state.
Measured: Time 0 (time of dosing) to 72 hours post-dose for each treatment condition
To assess the safety and tolerability of lunresertib tablets in combination with RP-3500, confirm the MTD of lunresertib tablets in combination with RP-3500, and determine a RP2D and preferred schedule
Assessed by DLTs, TEAEs, safety laboratory assessments, the incidence of DLTs and the incidence and severity of cumulative safety data
Measured: Up to 90 days after last administration of study intervention
Secondary outcomes (6)
The plasma concentrations of lunresertib monotherapy (capsule formulation) in the fasted and fed states
Assessed by the plasma concentrations of lunresertib with calculation of maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), minimum observed plasma concentration (Cmin), area under the plasma concentration-time curve (AUC), elimination half-life (t1/2), and other parameters as appropriate
Measured: Up to 90 days after last administration of study intervention
To assess the relationship between pharmacodynamic biomarkers and PK of lunresertib at different dose levels and/or schedules
Assessed by evaluation of biomarkers in pre- and on-treatment biopsies, and circulating tumor DNA (ctDNA) dynamics during treatment
Measured: Up to 90 days after last administration of study intervention
The plasma concentrations of lunresertib and RP-3500 when dosed in combination
Assessed by the plasma concentrations of lunresertib and RP-3500 with calculation of maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), minimum observed plasma concentration (Cmin), area under the plasma concentration-time curve (AUC), elimination half-life (t1/2), and other parameters as appropriate for each analyte
Measured: Up to 90 days after last administration of study intervention
To assess preliminary anti-tumor activity achieved with lunresertib monotherapy, lunresertib in combination with RP-3500 or lunresertib in combination with Zedoresertib
Measured by best percent change in tumor size from baseline, objective response rate (ORR), overall response rate, tumor marker response, duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS).
Measured: Through Study Completion, an average of 1 year
To assess the safety and anti-tumor effects of lunresertib capsule + RP-3500
As measure by TEAEs, safety laboratory assessments, Best percent change in tumor size from baseline, ORR, overall response rate, DOR, CBR, tumor marker response, PFS
Measured: Through Study Completion, an average of 1 year
To further characterize the PK of lunresertib tablets and assess preliminary anti-tumor
Measured by Plasma concentrations of lunresertib with calculation of Cmax, Tmax, AUC, elimination t1/2, and other PK parameters as appropriate, Best percent change in tumor size from baseline, ORR, overall response rate, DOR, CBR, tumor marker response, PFS
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 posted22 Apr 2021
- Study start30 Apr 2021
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855656
- Sponsor's protocol ID
- Debio 0123-106
- Other IDs
- RP-6306-01
- Acronym
- MYTHIC
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2021
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04855656
- Acronym / sponsor ID
- MYTHIC / Debio 0123-106
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Apr 2021 (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.
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with zedoresertib in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
Detailed description
Phase 1/1b, multi-center, open-label, dose-escalation study to:
- Evaluate the safety profile and MTD of lunresertib alone and in combination with RP-3500 or in combination with zedoresertib when administered orally to establish the recommended Phase 2 dose and schedule
- Characterize the PK and pharmacodynamics of lunresertib alone and in combination with RP-3500 or in combination with zedoresertib
- Assess preliminary anti-tumor activity associated with lunresertib alone and in combination with RP-3500 or in combination with zedoresertib
This study was previously posted by Repare Therapeutics. In September 2025, sponsorship of the trial was transferred to Debiopharm International S.A
Expanded Access Status: There is no expanded access program available for the investigational products in this study at this time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Lunresertib Single-Agent, Dose Escalation and Food-effect Study | Experimental | Drug: LunresertibPatients receive lunresertib orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified. |
| Phase 1: Lunresertib in combination with RP-3500, Dose Escalation Study | Experimental | Drug: Lunresertib, Drug: RP-3500Patients receive lunresertib with RP-3500 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified. |
| Phase 1: Lunresertib in combination with Zedoresertib, Dose Escalation Study | Experimental | Drug: Lunresertib, Drug: ZedoresertibPatients receive lunresertib with zedoresertib orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female and ≥12 years-of-age at the time of informed consent.
- Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients >16 years of age.
- Locally advanced or metastatic resistant or refractory solid tumors.
- Patients <18 years of age must weigh at least 40 kg.
- Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible
Key exclusion criteria (9 listed)
- Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-lives, whichever is shorter, prior to first dose of study drug.
- History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.
- Patients who are pregnant or breastfeeding.
- Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.
- Major surgery within 4 weeks prior to first dose of lunresertib.
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 |
|---|---|---|
| LunresertibOral PKMYT1 Inhibitor | Drug | Phase 1: Lunresertib Single-Agent, Dose Escalation and Food-effect Study, Phase 1: Lunresertib in combination with RP-3500, Dose Escalation Study, Phase 1: Lunresertib in combination with Zedoresertib, Dose Escalation Study |
| RP-3500Oral ATR Inhibitor | Drug | Phase 1: Lunresertib in combination with RP-3500, Dose Escalation Study |
| ZedoresertibAlso: Debio 0123Oral WEE1 Inhibitor | Drug | Phase 1: Lunresertib in combination with Zedoresertib, Dose Escalation Study |
Primary outcome
Safety and Tolerability of lunresertib either in monotherapy or in combination with RP-3500 or with Zedoresertib in patients with eligible advanced solid tumors
Time frame: Up to 90 days after last administration of study intervention
Assessed by treatment-emergent adverse events (TEAEs), physical examinations (PEs), safety laboratory assessments, electrocardiograms (ECGs), and vital sign measurements
To define the MTD of lunresertib monotherapy, and determine a recommended Phase 2 dose (RP2D) and preferred schedule
Time frame: Up to 90 days after last administration of study intervention
Assessed by the incidence of Dose-limiting toxicities (DLTs) and the incidence and severity of cumulative safety data
To define the MTD of lunresertib in combination with RP-3500 or in combination with Zedoresertib, and determine a recommended Phase 2 dose (RP2D) and preferred schedule
Time frame: Up to 90 days after last administration of study intervention
Assessed by the incidence of dose-limiting toxicities (DLTs) and the incidence and severity of cumulative safety data
The relative bioavailability of lunresertib capsule formulation as compared to lunresertib tablet formulation in the fasted state
Time frame: Time 0 (time of dosing) to 72 hours post-dose for each treatment condition
Assessed by the plasma concentrations of lunresertib with calculation of pharmacokinetic (PK) parameters including maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), area under the plasma concentration-time curve (AUC) , for both formulations in the fasted state.
The effect of food on the PK of tablet formulation of lunresertib when administered in fed conditions compared to administration under fasted conditions
Time frame: Time 0 (time of dosing) to 72 hours post-dose for each treatment condition
Assessed by the plasma concentrations of lunresertib with calculation of the ratio of PK parameters (e.g., Cmax and AUC) between the tablet formulation under fasted and fed state.
To assess the safety and tolerability of lunresertib tablets in combination with RP-3500, confirm the MTD of lunresertib tablets in combination with RP-3500, and determine a RP2D and preferred schedule
Time frame: Up to 90 days after last administration of study intervention
Assessed by DLTs, TEAEs, safety laboratory assessments, the incidence of DLTs and the incidence and severity of cumulative safety data
6 secondary outcomes
The plasma concentrations of lunresertib monotherapy (capsule formulation) in the fasted and fed states
Time frame: Up to 90 days after last administration of study intervention
To assess the relationship between pharmacodynamic biomarkers and PK of lunresertib at different dose levels and/or schedules
Time frame: Up to 90 days after last administration of study intervention
The plasma concentrations of lunresertib and RP-3500 when dosed in combination
Time frame: Up to 90 days after last administration of study intervention
To assess preliminary anti-tumor activity achieved with lunresertib monotherapy, lunresertib in combination with RP-3500 or lunresertib in combination with Zedoresertib
Time frame: Through Study Completion, an average of 1 year
To assess the safety and anti-tumor effects of lunresertib capsule + RP-3500
Time frame: Through Study Completion, an average of 1 year
To further characterize the PK of lunresertib tablets and assess preliminary anti-tumor
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lunresertib, RP-3500 and Zedoresertib in people with Advanced Solid Tumor, run by Debiopharm International SA at 26 sites in 5 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 15 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 28 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 26 sites in United States, Spain, Canada, Denmark, 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 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 Debiopharm International S.A (+41 21 321 01 11, clinicaltrials@debiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of lunresertib either in monotherapy or in combination with RP-3500 or with Zedoresertib in patients with eligible advanced solid tumors (time frame: Up to 90 days after last administration of study intervention). The study lists 6 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 28 Oct 2026.