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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06960395
Registration number
NCT06960395
Ethics application status
Date submitted
21/04/2025
Date registered
7/05/2025
Date last updated
29/06/2025
Titles & IDs
Public title
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
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Scientific 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
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Secondary ID [1]
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U1111-1294-8156
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Secondary ID [2]
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VIR-5525-V101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumor Malignancies
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EGFR Positive Solid Tumors
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EGFR
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - VIR-5525
Treatment: Drugs - Pembrolizumab
Experimental: Part 1: VIR-5525 Monotherapy Dose Escalation - Screening Period: Up to 28 days
Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy.
Experimental: Part 2: VIR-5525 Monotherapy Dose Expansion - Screening Period: Up to 28 days
Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy.
Experimental: Part 3: VIR-5525 Combination Dose Escalation - Screening Period: Up to 28 days
Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab.
Experimental: Part 4: VIR-5525 Combination Dose Expansion - Screening Period: Up to 28 days
Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab.
Treatment: Drugs: VIR-5525
Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion
Treatment: Drugs: Pembrolizumab
Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Safety Objectives (Parts 1 and 3)
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Assessment method [1]
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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.
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Timepoint [1]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Primary outcome [2]
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Primary Safety Objectives (Parts 1 and 3)
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Assessment method [2]
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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.
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Timepoint [2]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Primary outcome [3]
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Primary Efficacy Objectives (Parts 2 and 4)
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Assessment method [3]
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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.
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Timepoint [3]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Secondary outcome [1]
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Secondary Safety Objectives (Parts 1 and 3)
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Assessment method [1]
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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.
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Timepoint [1]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Secondary outcome [2]
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Secondary Efficacy Objectives (Parts 1 and 3)
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Assessment method [2]
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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.
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Timepoint [2]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Secondary outcome [3]
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Secondary Efficacy Objectives (Parts 2 and 4)
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Assessment method [3]
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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.
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Timepoint [3]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Secondary outcome [4]
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Secondary Efficacy Objectives (Parts 2 and 4)
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Assessment method [4]
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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.
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Timepoint [4]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Secondary outcome [5]
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Secondary PK Objectives (Parts 1 Through 4)
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Assessment method [5]
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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.
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Timepoint [5]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Secondary outcome [6]
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Secondary PK Objectives (Parts 1 Through 4)
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Assessment method [6]
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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.
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Timepoint [6]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Secondary outcome [7]
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Secondary PK Objectives (Parts 1 Through 4)
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Assessment method [7]
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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.
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Timepoint [7]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Secondary outcome [8]
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Secondary PK Objectives (Parts 1 Through 4)
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Assessment method [8]
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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.
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Timepoint [8]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Secondary outcome [9]
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Secondary Immunogenicity Objectives (Parts 1 Through 4)
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Assessment method [9]
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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.
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Timepoint [9]
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From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
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Eligibility
Key inclusion criteria
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:
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.
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• 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2029
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Actual
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Sample size
Target
450
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Wollongong Hospital - Wollongong
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Recruitment hospital [2]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Vir Biotechnology, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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. 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
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Trial website
https://clinicaltrials.gov/study/NCT06960395
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Vir Biotechnology
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Study Inquiry
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Address
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Country
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Phone
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1-415-654-5281
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Fax
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Email
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clinicaltrials@vir.bio
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06960395
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