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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
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)
Assessment method [1] 0 0
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.
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)
Assessment method [2] 0 0
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.
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)
Assessment method [3] 0 0
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.
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)
Assessment method [1] 0 0
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.
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)
Assessment method [2] 0 0
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.
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)
Assessment method [3] 0 0
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.
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)
Assessment method [4] 0 0
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.
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)
Assessment method [5] 0 0
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.
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)
Assessment method [6] 0 0
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.
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)
Assessment method [7] 0 0
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.
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)
Assessment method [8] 0 0
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.
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)
Assessment method [9] 0 0
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.
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.

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.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Vir Biotechnology
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Inquiry
Address 0 0
Country 0 0
Phone 0 0
1-415-654-5281
Email 0 0
clinicaltrials@vir.bio
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.