Status:
RECRUITING
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Vir Biotechnology, Inc.
Conditions:
Solid Tumor Malignancies
EGFR Positive Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06960395
Start Date
July 22 2025
End Date
August 1 2029
Last Update
August 6 2025
Active Locations (3)
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1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258-4566
2
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
3
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102