Phase
Condition
Neoplasms
Treatment
Pembrolizumab
VIR-5525
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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: asymptomaticEBV-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 aknown 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 [HCVRNA; qualitative] is detected)
History of HIV infection. No HIV testing is required unless mandated by the localhealth 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 isnegative, participants may be eligible if asymptomatic and upon consultation withmedical 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
Connect with a study center
Wollongong Hospital
Wollongong, New South Wales 2500
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Honor Health Research Institute
Scottsdale, Arizona 85258-4566
United StatesActive - Recruiting
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