Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06960395 | RECRUITING | Solid Tumor Malignancies

Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor:

Vir Biotechnology, Inc.

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

Condition or disease

Solid Tumor Malignancies

EGFR Positive Solid Tumors

EGFR

Intervention/treatment

VIR-5525

Pembrolizumab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 450 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-07-22
Estimated Primary Completion Date : 2029-08
Estimated Study Completion Date : 2029-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
      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.
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Location Details

NCT06960395

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Honor Health Research Institute

Scottsdale, Arizona, United States, 85258-4566

RECRUITING

Australia, New South Wales

Wollongong Hospital

Wollongong, New South Wales, Australia, 2500

NOT YET RECRUITING

Australia, Queensland

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102