Solid Tumor MalignanciesPhase 1NCT06960395
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing VIR-5525 and Pembrolizumab in people with Solid Tumor Malignancies and EGFR Positive Solid Tumors, run by Vir Biotechnology, Inc. at 4 sites in 2 countries.
Trial summary
This Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies, EGFR Positive Solid Tumors, EGFR
- What is being tested?
- VIR-5525 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 22 Jul 2025to Aug 2029
- 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
- I 01. Are ≥ 18 years of age, or at the country's legal age of majority of the legal adult age is >18 years, at the time of signing the ICF.
- I 02. Have an ECOG performance status of 0 to 1.
- I 03. Have a life expectancy of at least 12 weeks.
- I 04. Have histological, pathological, or cytological confirmation of disease type that is unresectable, locally advanced, or metastatic.
- I 05. Have measurable disease per RECIST v1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- I 06. Have diseases under study, lines of therapy, and biomarker status, as follows:
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- Have one of the following:
- (Parts 1 and 3): NSCLC (nonsquamous or squamous histology), CRC, HNSCC, or CSCC.
- Note: Participants with nasopharyngeal tumors are eligible. Note: Participants with upper esophageal or salivary gland tumors are not eligible.
- OR
- Have a solid tumor with EGFR amplification (as previously determined locally with an analytically validated assay in a certified testing laboratory).
- Have no available standard systemic therapy; or standard therapy is intolerable, not effective, or not accessible; or participant has refused standard therapy.
Who cannot join
- E 01. Are a WOCBP with a positive serum or urine pregnancy test within 72 hours prior to treatment.
- E 02. Have acute or chronic infections, including the following:
- Acute or chronic active Epstein-Barr virus (EBV) infection (Exception: asymptomatic EBV-positive participants are still eligible)
- Chronic active EBV disease defined as a chronic illness lasting at least 6 months, an increased EBV level in either the tissue or the blood, and lack of evidence of a known underlying immunodeficiency
- History of hepatitis B infection (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) infection (defined as HCV [HCV RNA; qualitative] is detected)
- History of HIV infection. No HIV testing is required unless mandated by the local health authority.
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- Active infection requiring systemic therapy within 14 days of Cycle 1 Day 1
- Known positive COVID-19 test result at screening (Exception: If follow-up test is negative, participants may be eligible if asymptomatic and upon consultation with medical monitor)
- E 03. Have a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5525 or pembrolizumab, per the investigator
- E 04. Have a QT interval corrected by Fridericia's method (QTcF) that is >480 ms
- E 05. Have received prior systemic anti-cancer therapy, including investigational agents, within 5 half-lives prior to first dose of study intervention. For drugs with a long t1/2, such as mAbs, or for drugs for which the t1/2 is not known, the last dose should not have been within 28 days prior to first dose of study intervention.
- Note: If the participant has had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention.
- E 06. Have received prior radiotherapy within 2 weeks of start of study intervention Note: Participants must have recovered from all radiation-related toxicities to Grade ≤1 or baseline, must not require corticosteroids, and must not have had radiation pneumonitis.
- Exception: External beam radiotherapy, including palliative external radiation, is allowed.
- A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
MD Anderson
Houston, Texas, 77030
- Recruiting
Honor Health Research Institute
Scottsdale, Arizona, 85258-4566
Australia2 sites, 2 recruiting
- Recruiting
Wollongong Hospital
Wollongong, New South Wales, 2500
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
Official title: A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5525 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
This Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR.
The study will be conducted in the following 4 parts:
- Part 1: VIR-5525 monotherapy dose escalation
- Part 2: VIR-5525 monotherapy dose expansion
- Part 3: VIR-5525 plus pembrolizumab dose escalation
- Part 4: VIR-5525 plus pembrolizumab dose expansion
- Conditions
- Solid Tumor Malignancies, EGFR Positive Solid Tumors, EGFR
- Being tested
- VIR-5525, Pembrolizumab
- Keywords
- VIR-5525
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIR-5525Drug
Also called AMX-525
Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion
PembrolizumabDrug
Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: VIR-5525 Monotherapy Dose Escalation | Experimental | Screening Period: Up to 28 days
Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy. Receives: Drug: VIR-5525 |
| Part 2: VIR-5525 Monotherapy Dose Expansion | Experimental | Screening Period: Up to 28 days
Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy. Receives: Drug: VIR-5525 |
| Part 3: VIR-5525 Combination Dose Escalation | Experimental | Screening Period: Up to 28 days
Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab. Receives: Drug: VIR-5525; Drug: Pembrolizumab |
| Part 4: VIR-5525 Combination Dose Expansion | Experimental | Screening Period: Up to 28 days
Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab. Receives: Drug: VIR-5525; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Objectives (Parts 1 and 3)
Objective: To evaluate the safety and tolerability of escalating doses of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3).
Endpoint: Incidence and severity of AEs, including DLTs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Primary Safety Objectives (Parts 1 and 3)
Objective: To determine the recommended dose(s) for expansion cohorts of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3).
Endpoint: Incidence and severity of AEs, including DLTs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Primary Efficacy Objectives (Parts 2 and 4)
Objective: To evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 2) and in combination with pembrolizumab (Part 4) at the recommended dose(s) for expansion cohorts.
Endpoint: Objective response, defined as a CR or PR per RECIST v1.1.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary outcomes (9)
Secondary Safety Objectives (Parts 1 and 3)
Objective: To further evaluate the safety and tolerability of VIR-5525 as a monotherapy (Part 2) and in combination with pembrolizumab (Part 4).
Endpoint: Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary Efficacy Objectives (Parts 1 and 3)
Objective: To evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3).
Endpoint: Objective response, defined as a CR or PR per RECIST v1.1.
Endpoint: DOR, defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST v1.1.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary Efficacy Objectives (Parts 2 and 4)
Objective: To further evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 2) and in combination with pembrolizumab (Part 4) at the recommended dose(s) for expansion cohorts and schedule.
Endpoint: DOR, defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST v1.1.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary Efficacy Objectives (Parts 2 and 4)
Objective: To further evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 2) and in combination with pembrolizumab (Part 4) at the recommended dose(s) for expansion cohorts and schedule.
Endpoint: PFS (per investigator using RECIST v1.1), defined as the length of time from the start of treatment until first documented disease progression or death.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary PK Objectives (Parts 1 Through 4)
Objective: To characterize the PK profile of VIR-5525 as monotherapy (Parts 1 and 2) and in combination with pembrolizumab (Parts 3 and 4).
Endpoint: PK parameters of VIR-5525, including, but not limited to, area under the curve (AUC), calculated as data allow.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary PK Objectives (Parts 1 Through 4)
Objective: To characterize the PK profile of VIR-5525 as monotherapy (Parts 1 and 2) and in combination with pembrolizumab (Parts 3 and 4).
Endpoint: PK parameters of VIR-5525, including, but not limited to, maximum concentration of the drug (Cmax), calculated as data allow.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary PK Objectives (Parts 1 Through 4)
Objective: To characterize the PK profile of VIR-5525 as monotherapy (Parts 1 and 2) and in combination with pembrolizumab (Parts 3 and 4).
Endpoint: PK parameters of VIR-5525, including, but not limited to, time to peak drug concentration (tmax), calculated as data allow.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary PK Objectives (Parts 1 Through 4)
Objective: To characterize the PK profile of VIR-5525 as monotherapy (Parts 1 and 2) and in combination with pembrolizumab (Parts 3 and 4).
Endpoint: PK parameters of VIR-5525, including, but not limited to, drug accumulation ratio (Rac), calculated as data allow.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary Immunogenicity Objectives (Parts 1 Through 4)
Objective: To evaluate the immunogenicity of VIR-5525 as monotherapy (Parts 1 and 2) and in combination with pembrolizumab (Parts 3 and 4).
Endpoint: Incidence of ADAs to VIR-5525 at baseline and incidence of treatment-emergent ADAs to VIR-5525.
Measured: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start22 Jul 2025
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Vir Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960395
- Sponsor's protocol ID
- VIR-5525-V101
- Other IDs
- U1111-1294-8156, 2023-508555-39, AMX-525, 2023
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2025
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5525 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06960395
- Acronym / sponsor ID
- VIR-5525-V101
- Conditions
- Solid Tumor Malignancies, EGFR Positive Solid Tumors, EGFR
- Keywords
- VIR-5525
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 7 May 2025 (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 Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR.
The study will be conducted in the following 4 parts:
- Part 1: VIR-5525 monotherapy dose escalation
- Part 2: VIR-5525 monotherapy dose expansion
- Part 3: VIR-5525 plus pembrolizumab dose escalation
- Part 4: VIR-5525 plus pembrolizumab dose expansion
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: VIR-5525 Monotherapy Dose Escalation | Experimental | Drug: VIR-5525Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy. |
| Part 2: VIR-5525 Monotherapy Dose Expansion | Experimental | Drug: VIR-5525Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy. |
| Part 3: VIR-5525 Combination Dose Escalation | Experimental | Drug: VIR-5525, Drug: PembrolizumabScreening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab. |
| Part 4: VIR-5525 Combination Dose Expansion | Experimental | Drug: VIR-5525, Drug: PembrolizumabScreening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- I 01. Are ≥ 18 years of age, or at the country's legal age of majority of the legal adult age is >18 years, at the time of signing the ICF.
- I 02. Have an ECOG performance status of 0 to 1.
- I 03. Have a life expectancy of at least 12 weeks.
- I 04. Have histological, pathological, or cytological confirmation of disease type that is unresectable, locally advanced, or metastatic.
- I 05. Have measurable disease per RECIST v1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Key exclusion criteria (16 listed)
- E 01. Are a WOCBP with a positive serum or urine pregnancy test within 72 hours prior to treatment.
- Acute or chronic active Epstein-Barr virus (EBV) infection (Exception: asymptomatic EBV-positive participants are still eligible)
- Chronic active EBV disease defined as a chronic illness lasting at least 6 months, an increased EBV level in either the tissue or the blood, and lack of evidence of a known underlying immunodeficiency
- History of hepatitis B infection (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) infection (defined as HCV [HCV RNA; qualitative] is detected)
- History of HIV infection. No HIV testing is required unless mandated by the local health authority.
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 |
|---|---|---|
| VIR-5525Also: AMX-525Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion | Drug | Part 1: VIR-5525 Monotherapy Dose Escalation, Part 2: VIR-5525 Monotherapy Dose Expansion, Part 3: VIR-5525 Combination Dose Escalation, Part 4: VIR-5525 Combination Dose Expansion |
| PembrolizumabPharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion | Drug | Part 3: VIR-5525 Combination Dose Escalation, Part 4: VIR-5525 Combination Dose Expansion |
Primary outcome
Primary Safety Objectives (Parts 1 and 3)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Objective: To evaluate the safety and tolerability of escalating doses of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3). Endpoint: Incidence and severity of AEs, including DLTs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.
Primary Safety Objectives (Parts 1 and 3)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Objective: To determine the recommended dose(s) for expansion cohorts of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3). Endpoint: Incidence and severity of AEs, including DLTs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.
Primary Efficacy Objectives (Parts 2 and 4)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Objective: To evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 2) and in combination with pembrolizumab (Part 4) at the recommended dose(s) for expansion cohorts. Endpoint: Objective response, defined as a CR or PR per RECIST v1.1.
9 secondary outcomes
Secondary Safety Objectives (Parts 1 and 3)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary Efficacy Objectives (Parts 1 and 3)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary Efficacy Objectives (Parts 2 and 4)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary Efficacy Objectives (Parts 2 and 4)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary PK Objectives (Parts 1 Through 4)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary PK Objectives (Parts 1 Through 4)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary PK Objectives (Parts 1 Through 4)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary PK Objectives (Parts 1 Through 4)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary Immunogenicity Objectives (Parts 1 Through 4)
Time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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 13 Apr 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.
Clinical Sciences & Operations study director
Vir Biotechnology
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIR-5525 and Pembrolizumab in people with Solid Tumor Malignancies and EGFR Positive Solid Tumors, run by Vir Biotechnology, Inc. at 4 sites in 2 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 12 inclusion and 16 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 13 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 4 sites in United States, 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 Study Inquiry (1-415-654-5281, clinicaltrials@vir.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Objectives (Parts 1 and 3) (time frame: From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.). The study lists 3 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 13 Apr 2026.