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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

Titles & IDs
Public title
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
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
Secondary ID [1] 0 0
U1111-1294-8156
Secondary ID [2] 0 0
VIR-5525-V101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor Malignancies 0 0
EGFR Positive Solid Tumors 0 0
EGFR 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Objectives (Parts 1 and 3)
Timepoint [1] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Primary outcome [2] 0 0
Primary Safety Objectives (Parts 1 and 3)
Timepoint [2] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Primary outcome [3] 0 0
Primary Efficacy Objectives (Parts 2 and 4)
Timepoint [3] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary outcome [1] 0 0
Secondary Safety Objectives (Parts 1 and 3)
Timepoint [1] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary outcome [2] 0 0
Secondary Efficacy Objectives (Parts 1 and 3)
Timepoint [2] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary outcome [3] 0 0
Secondary Efficacy Objectives (Parts 2 and 4)
Timepoint [3] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary outcome [4] 0 0
Secondary Efficacy Objectives (Parts 2 and 4)
Timepoint [4] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary outcome [5] 0 0
Secondary PK Objectives (Parts 1 Through 4)
Timepoint [5] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary outcome [6] 0 0
Secondary PK Objectives (Parts 1 Through 4)
Timepoint [6] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary outcome [7] 0 0
Secondary PK Objectives (Parts 1 Through 4)
Timepoint [7] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary outcome [8] 0 0
Secondary PK Objectives (Parts 1 Through 4)
Timepoint [8] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
Secondary outcome [9] 0 0
Secondary Immunogenicity Objectives (Parts 1 Through 4)
Timepoint [9] 0 0
From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.

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.

* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2029
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vir Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Vir Biotechnology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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