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Advanced or Metastatic Solid TumorsPhase 1MarkV-01NCT05957081

Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309

A Phase 1 study testing PMC-309 monotherapy, PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®) and PMC-309 Dose Expansion in people with Advanced or Metastatic Solid Tumors, run by PharmAbcine at 4 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 1a/1b, first-in-human (FIH), open label study to evaluate the safety, tolerability, and pharmacokinetics (PK) of PMC-309, a mAb against the human VISTA ligand, in participants with advanced or metastatic solid tumors administered as a monotherapy and in combination with pembrolizumab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced or Metastatic Solid Tumors
What is being tested?
PMC-309 monotherapy, PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®) and PMC-309 Dose Expansion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
4 sitesAustralia
Study dates
3 Jan 2024to 30 Apr 2030
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

  • To be eligible for this study, a participant must meet ALL of the following inclusion criteria:
  • The participant voluntarily signs an informed consent form (ICF) indicating they understand the purpose and procedures required for the study and are willing to participate in the study.
  • Are at least 18 years of age.
  • Are diagnosed with advanced or metastatic solid tumors (non-lymphoma) by histology or pathology that is metastatic or unresectable and considered relapsed and/or refractory to prior therapy.
  • Definition of anti-PD-1/L1 refractory participant:
  • Participants must have progressed on treatment with an anti-PD1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:
Show all 33Show fewer
  • Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
  • Has demonstrated disease progression (PD) after PD-1/L1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression.
  • PD has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.
  • PD is determined according to iRECIST v1.1. ii. This determination is made by the PI (or designee). Once PD is confirmed, the initial date of PD documentation will be considered the date of disease progression
  • Have measurable disease per RECIST v1.1 documented by computerized tomography scan (CT scan) and/or magnetic resonance imaging (MRI), measurable at Baseline. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have an ECOG performance status of 0 or 1.
  • Can satisfy the following criteria in hematologic, renal, and hepatic function tests performed within 7 days prior to screening:
  • Hematologic tests:
  • ANC more than and equal to 1.5 × 109 per L.
  • Platelets more than and equal to 100 × 109 per L.
  • Hemoglobin more than and equal to 9.0 g per dL or more than and equal to 5.6 mmol per L.
  • Note: Criteria must be met without packed red blood cell (pRBC) transfusion within the prior 2 weeks. Participants can be on a stable dose of erythropoietin (more than equal to approximately 3 months).
  • Blood coagulation tests:
  • Prothrombin time less than and equal to 1.5 × upper limit of normal (ULN).
  • Activated partial thromboplastin time less than and equal to 1.5 × ULN.
  • Hepatic function tests:
  • Total bilirubin less than and equal to 1.5 × ULN or direct bilirubin less than and equal to ULN for participants with total bilirubin levels more than and equal to 1.5 × ULN.
  • Aspartate aminotransferase or alanine aminotransferase less than and equal to 2.5 × ULN (less than and equal to 5× ULN in case of liver metastasis).
  • Renal function test:
  • less than and equal to 1.5 × ULN or creatinine clearance more than and equal to 30 mL/min for participant with creatinine levels above 1.5 × institutional ULN.
  • Are willing and able to adhere to the prohibitions and restrictions as specified in the study protocol.
  • Eligible participants (male and female) of childbearing potential must agree to use reliable contraception (hormone, barrier method, or abstinence) from Screening (Day -1) until at least 120 days after administration of the last dose of the IP.
  • Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Screening (Day -1) and be willing to have additional pregnancy tests as required throughout the study.
  • Human immunodeficiency virus (HIV) infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease defined as:
  • Participants on ART must have a CD4+ T-cell count 350 cells/mm3 at time of Screening.
  • Participants on ART must have achieved and maintained virologic suppression defined as confirmed by HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of Screening and for at least 12 weeks prior to Screening.
  • Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry (Day 1).

Who cannot join

  • A participant who meets ANY of the following exclusion criteria must be excluded from the study:
  • Has received treatment with a VISTA targeting agent.
  • Has a history of positive testing for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-hepatitis C virus) or other clinically active liver disease, or positive testing at Screening for HBsAg or anti- hepatitis C virus.
  • HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
  • Has a medical condition which, in the opinion of the PI (or designee), places the participant at an unacceptably high risk for toxicity.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Show all 42Show fewer
  • Is currently participating in or has participated in a study of an investigational agent or have received anticancer immunotherapy within 4 weeks prior to the first dose of IP.
  • Has an active autoimmune disease with a history of flares requiring immunosuppressant medications within the past 6 months or that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • History of known or suspected seizure disorder.
  • Has oxygen-dependent chronic disease.
  • Serious Grade 4 venous thromboembolic event including pulmonary embolism.
  • Participant is receiving therapeutic anticoagulants.
  • Has had an allogeneic tissue/solid organ transplant.
  • Major surgery (eg, requiring general anesthesia) within 4 weeks before the planned first dose of the IP, or not fully recovered from prior surgery, or has surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of IP.
  • Fertility exclusions:
  • Participant is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 120 days after the last dose of IP; WOCBP must have a negative pregnancy status confirmed by urine pregnancy test at Screening and within 72 hours of first dose of the IP. (If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.)
  • Participant is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of the IP.
  • Male participants must also refrain from sperm donation during the treatment period and for 5 terminal half-lives (of PMC-309) plus an additional 90 days (a spermatogenesis cycle).
  • Note: The half-life of PMC-309 is 47 hours.
  • Vaccinated with a live vaccine within 30 days (with the exception of the annual inactivated influenza vaccine) prior to the first dose of the IP.
  • Received COVID-19 vaccine within 7 days of the first IP administration.
  • Any medical condition for which, in the opinion of the PI or designee, participation would not be in the best interest of the participant (eg, compromise the well-being of the participant) or that could prevent, limit, or confound the protocol specified assessments.
  • Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension; poorly controlled diabetes; ongoing active infection requiring antibiotics or acute infectious illness (including suspected viral infection); symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia considered to increase risk for the participant by the PI (or designee); or active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder, treated depression with ongoing antidepressant medication etc.) that would limit compliance with study requirements.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (at a dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of IP.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression for at least 4 weeks by repeat imaging [note that the repeat imaging should be performed during Screening], clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of IP).
  • Prior allogeneic organ or bone marrow transplant.
  • Participant has had prior therapy meeting the following:
  • Prior T-cell receptor-modified or chimeric antigen receptor T-cell (CART) therapy.
  • Other anticancer therapy, including chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 4 weeks prior to the first dose of IP.
  • Has received prior radiotherapy (excluding limited palliative radiation) within 2 weeks of start of IP or has a history of radiation pneumonitis.
  • Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (less than and equal to 2 weeks of radiotherapy) to non-CNS disease.
  • Except for hearing loss, alopecia and pigmentation, all toxicity caused by previous anti-tumor therapy has recovered to Grade 1 or less.
  • Participant received prior therapy with an anti-PD-1 or anti-PD-L1 mAb or with an agent targeting stimulatory or co-inhibitory T-cell receptors and was discontinued from that treatment due to a Grade 3 or higher immune related AE.
  • Participant has an active autoimmune disease that required systemic treatment in the past.
  • Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
  • Class III or IV heart failure by New York Heart Association (NYHA) classification.
  • History of abdominal fistula or gastrointestinal perforation within 6 months prior to start of IP administration.
  • History of serious gastrointestinal hemorrhage within 6 months prior to start of IP administration.
  • History of hypertensive crisis or hypertensive encephalopathy.
  • History of posterior reversible encephalopathy syndrome.
  • Social situation that would limit compliance with study requirements.
  • A diagnosis of immunodeficiency or is receiving chronic systemic corticosteroids at a dose that exceeds 10 mg daily of prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior the first dose of the IP. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hyojin Koh, Dr contact

070-4213-2925

hyojin.koh@pharmabcine.com

Australia4 sites, 4 recruiting

  • Ballarat Regional Integrated Cancer Centre (Grampians Health)

    Ballarat, Victoria, 3350

    Lisi Lim, Dr, 0457248899, lizzie.lim@gh.org.au

    Recruiting

  • Australian Hospital Care (Pindara) PTY LTD. Trading as Pindara Private Hospital

    Benowa, Queensland, 4217

    Andrea Tazbirkova, Dr, 0755971211, tazbirkova@yahoo.com.au

    Recruiting

  • Cabrini Health Limited

    Malvern, Victoria, 3144

    Shehara Mendis, Dr, 0422405852, Shehara.Mendis@mh.org.au

    Recruiting

  • Alfred Health

    Melbourne, Victoria, 3004

    Mark Voskoboynik, Dr, 0390762000, M.Voskoboynik@alfed.org.au

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 1a/1b, First-in-Human, Open Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of PMC-309 (Anti-VISTA), as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors

This is a Phase 1a/1b, first-in-human (FIH), open label study to evaluate the safety, tolerability, and pharmacokinetics (PK) of PMC-309, a mAb against the human VISTA ligand, in participants with advanced or metastatic solid tumors administered as a monotherapy and in combination with pembrolizumab.

Read the detailed description

Phase 1a is a 2-part dose escalation; both part will adopt the modified toxicity probability interval (mTPI) design with a dose limiting toxicity (DLT) rate of 30% for dose finding.

  • Part A is planned as a PMC-309 dose escalation.
  • Part B: is planned as a PMC-309 dose escalation in combination with pembrolizumab.

Phase 1b is planned as a cohort expansion with PMC-309 administered as a monotherapy (Cohort A) at the preliminary recommended Phase 2 dose (RP2D) found at Phase 1a (Part A) and in combination with pembrolizumab (Cohort B) with PMC-309 at the maximum tolerated dose (MTD)/preliminary recommended Phase 2 dose (RP2D) found at Phase 1a (Part B).

A minimum of 67 participants are to be enrolled to the study.

Treatment Groups: Phase 1a Part A: PMC-309 Phase 1a Part B: PMC-309 + Pembrolizumab Phase 1b Cohort A: PMC-309 Phase 1b Cohort B: PMC-309 + Pembrolizumab Estimated overall study duration: approximately 2 to 6 years Dosing Cycle: the duration of a treatment cycle is 3 weeks/21 days.

Being tested
PMC-309 monotherapy, PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®), PMC-309 Dose Expansion
Keywords
PMC-309 and Anti-VISTA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PMC-309 monotherapyDrug

    Also called Monotherapy

    PMC-309 will be administered intravenously.

  • PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®)Drug

    Also called Combination Therapy

    Both PMC-309 and pembrolizumab will be administered intravenously. At the time of the combination therapy (Week 1/Day 1 of each cycle), participants will be dosed with pembrolizumab(KEYTRUDA®) first, administered over 0.5 hours (± 10 minutes). Following an interval of 1 hour (± 15 minutes), participants will be dosed with PMC-309 administered over 1 hour (± 0.5 hours), after which participants will be observed for a period of 1.5 hours post administration.

  • PMC-309 Dose ExpansionDrug

    Also called Mono and Combination therapy

    Phase 1b will enroll participants with advanced or metastatic tumor types into 1 of 2 cohorts:

    • Cohort A: PMC-309 monotherapy therapy
    • PMC-309 dosing will be at the preliminary RP2D, as identified in Phase 1a: Part A
    • Cohort B: PMC-309 plus pembrolizumab(KEYTRUDA®) combination therapy - PMC-309 dosing will be as identified in Phase 1a: Part B in combination with 200 mg pembrolizumab(KEYTRUDA®)
Study groups in NCT05957081
Study groupRoleWhat they receive
Phase 1 a: Part A: PMC-309 Monotherapy Dose EscalationExperimentalPhase 1a will enroll participants with advanced or metastatic solid tumors to assess safety, tolerability, PK and clinical efficacy in response to treatment with PMC-309 as a monotherapy Dosage form and Route of administration: The duration of a treatment cycle is 3 weeks/21 days. Participants will be administered a weekly dose of PMC-309 per cycle as follows: * Cycle Week 1/Day 1 * Cycle Week 2/Day 8 ± 2 days * Cycle Week 3/Day 15 ± 2 days PMC-309 will be administered intravenously over 1 hour (± 0.5 hours), after which participants will be observed for a period of 1.5 hours post administration.
Receives: Drug: PMC-309 monotherapy
Phase 1a: Part B: PMC-309 Dose Escalation in Combination with PembrolizumabExperimentalPart B will establish the MTD/preliminary RP2D of PMC-309 when administered in combination with 200 mg pembrolizumab. Part B will be conducted after completion of Part A (PMC-309 monotherapy dose escalation) and before the commencement of Phase 1b. Dosage form and Route of administration: The duration of a treatment cycle is 3 weeks/21 days. Participants will be administered a weekly dose of PMC-309 plus one dose of pembrolizumab at 200 mg per cycle as follows: * Cycle Week 1/Day 1: pembrolizumab (administered first), followed by administration of PMC-309. * Cycle Week 2/Day 8 ± 2 days: PMC-309 only * Cycle Week 3/Day 15 ± 2 days: PMC-309 only. Both PMC-309 and pembrolizumab will be administered intravenously.
Receives: Drug: PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®)
Phase 1b: Dose ExpansionExperimentalPhase 1b will enroll participants after completion of DLT assessments for Phase 1a. Phase 1b will enroll participants with advanced or metastatic tumor types into 1 of 2 cohorts to assess response of monotherapy of PMC-309 and response of PMC-309 in combination with pembrolizumab. * Cohort A: PMC-309 monotherapy therapy - PMC-309 dosing will be at the preliminary RP2D, as identified in Phase 1a: Part A * Cohort B: PMC-309 plus pembrolizumab combination therapy - PMC-309 dosing will be as identified in Phase 1a: Part B in combination with 200 mg pembrolizumab Participants will be randomly assigned to Cohort A or Cohort B until 20 participants are enrolled in each cohort.
Receives: Drug: PMC-309 Dose Expansion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with abnormal vital signs in response ot treatment with PMC- 309

    Vital signs will be assessed by changes in systolic/diastolic blood pressure, respiratory rate, body temperature and heart rate.

    Measured: Phase 1a and 1b- Upto 35 Cycles (each cycle is 21 days)

  2. Number of participants with abnomal clinically significant results with physical examination in response to the treatment with PMC-309

    A complete physical examinations of general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.

    Measured: Phase 1a and 1b- Upto 35 Cycles (each cycle is 21 days)

  3. Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters in response to treatment with PMC-309

    The following ECG parameters will be recorded: heart rate, RR interval, HR interval, QTc interval, and QRS interval.

    Measured: Phase 1a and 1b- Upto 35 Cycles (each cycle is 21 days)

  4. Number of participants with abnormal clinically significant laboratory results in response to treatment with PMC-309

    Laboratory results will include biochemistry, Thyroid function test, hematology, coagulation and urinalysis

    Measured: Phase 1a and 1b- Upto 35 Cycles (each cycle is 21 days)

  5. Number of participants with adverse events receiving treatment with PMC-309

    Adverse events includes [treatment-emergent AE, serious AEs, treatment-emergent AEs of special interest] which will be coded using most current version of MedDRA.

    Measured: Phase 1a and 1b- Upto 35 Cycles (each cycle is 21 days)

  6. Number of participants with abnormal changes in Eastern Cooperative Oncology Group (ECOG) performance status.

    Measured: Phase 1a and 1b- Screening

  7. Number of participants with abnormal changes in Eastern Cooperative Oncology Group (ECOG) performance status.

    Measured: Day1 of every cycle (each cycle is 21 days)

  8. To determine the maximum tolerated dose (MTD) of PMC-309 monotherapy (Part A) and establish the preliminary RP2D of PMC-309.

    MTD of PMC-309 will be calculated by incidence of DLT at 21 days from the first dosing of PMC 309.

    Measured: Upto 21 days

  9. To determine the MTD and establish the preliminary RP2D of PMC-309 when administered in combination with pembrolizumab at 200 mg (Part B).

    MTD of PMC-309 by incidence of DLT at 21 days from the first dosing of PMC-309 in combination with pembrolizumab.

    Measured: Upto 21 Days

Secondary outcomes (6)

  1. To assess the clinical efficacy of PMC-309 in the treatment of advanced or metastatic solid tumors by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    RECIST consisting of overall response rate (ORR), disease control rate (DCR) and progression-free survival (PFS) will be graded following CT/MRI of chest, abdomen and pelvis.

    Measured: Upto 35 Cycles (each cycle is 21 days)

  2. The plasma pharmacokinetic endpoints of the study is assessed by peak serum concentration (Cmax)

    Measured: Upto 35 Cycles (each cycle is 21 Days)

  3. The plasma pharmacokinetic endpoints of the study is assessed by time to peak plasma concentration (Tmax)

    Measured: Upto 35 Cycles (each cycle is 21 Days)

  4. PK parameter assessed by serum concentration at specified timepoints for area under curve (AUC)

    Measured: Upto 35 Cycles (each cycle is 21 Days)

  5. To assess the clinical efficacy of PMC-309 at the RP2D as a monotherapy and in combination with pembrolizumab

    This will be assessed by RECIST v1.1.

    Measured: Upto 35 Cycles (each cycle is 21 Days)

  6. PK parameter assessed by serum concentration over time of PMC-309 at the RP2D as a monotherapy and in combination with pembrolizumab.

    Measured: Upto 35 Cycles (each cycle is 21 Days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2023
  2. Study start3 Jan 2024
  3. Primary completion30 Oct 2029 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05957081
Sponsor's protocol ID
MarkV-01
Other IDs
KEYNOTE-E80, MK-3475-E80
Acronym
MarkV-01
Status last verified
Dec 2025
First submitted
26 May 2023
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PMC-309 monotherapy, PMC-309 Dose Escalation in Combination with Pembrolizumab(KEYTRUDA®) and PMC-309 Dose Expansion in people with Advanced or Metastatic Solid Tumors, run by PharmAbcine at 4 sites in Australia.

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 33 inclusion and 42 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 30 Dec 2025. 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 Australia. 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 Hyojin Koh, Dr (070-4213-2925, hyojin.koh@pharmabcine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with abnormal vital signs in response ot treatment with PMC- 309 (time frame: Phase 1a and 1b- Upto 35 Cycles (each cycle is 21 days)). The study lists 9 primary outcomes in all. 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 NCT05957081.

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 30 Dec 2025.

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