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Tests treatment safety and results for Solid Tumor Malignancies
Official title Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06960395
What this study is testing
What is VIR-5525?
VIR-5525 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor malignancies.
Also referred to as AMX-525.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- (Parts 1 and 3): NSCLC (nonsquamous or squamous histology), CRC, HNSCC, or CSCC. Note: Participants with nasopharyngeal tumors are eligible. Note...
- Have a solid tumor with EGFR amplification (as previously determined locally with an analytically validated assay in a certified testing laboratory)...
You likely can't join if
- 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...
- 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...
- History of hepatitis B infection (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) infection (defined...
- 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
See the full eligibility 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...
- (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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Houston, Texas, United States
- Wollongong, New South Wales, Australia
- Woolloongabba, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Houston, Texas, United States; Wollongong, New South Wales, Australia; Woolloongabba, Queensland, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.