IBRX-042 In Subjects With HPV-Associated Tumors

Eligibility Criteria

• 1. 18-75 years of age.
• 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
• 3. Histologically confirmed HPV-associated cancer documented as HPV- or p16-positive carcinoma (measurable or nonmeasurable disease).
• 4. Subjects must have received at least one standard of care therapy per National Comprehensive Cancer Network (NCCN) guidelines for their HPV-associated cancer \> 28 days prior to enrollment.
• 5. Availability of a representative formalin fixed, paraffin embedded tumor specimen or fresh frozen tissue specimen that enables the definitive diagnosis of an HPV- or p16- positive carcinoma, accompanied by an associated pathology report. Specimens can be collected by surgical resection, biopsy of the primary tumor or biopsy or resection of a metastatic lesion.
• 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• 7. Resolution of all toxic side effects of prior therapy for their HPV-associated cancer to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5 grade ≤ 1.
• 8. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• 9. Agreement to practice effective contraception for female subjects of child-bearing potential and nonsterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 30 days after last dose of study drug. Nonsterile male subjects must agree to use a condom while on study and for up to 30 days after the last dose of study drug. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, and intrauterine devices (IUDs).
• 10. Adequate organ function, evidenced by the following laboratory results:
• 1. Absolute neutrophil count (ANC): 1.5 x 109/L
• 2. Absolute lymphocyte count (ALC) \> institutional lower limit of normal
• 3. Hemoglobin ≥ 10.0 g/dL.
• 4. Platelet count: 100 × 109/L
• 5. Total bilirubin ≤ 1.5 × upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
• 6. Aspartate aminotransferase \[serum glutamic-oxaloacetic transaminase\] (AST \[SGOT\]) or alanine aminotransferase \[serum glutamic-pyruvic transaminase\] (ALT \[SGPT\]) ≤ 3.0 × ULN. For patients with significant hepatic involvement by tumor, ALT ≤ 5 × ULN is acceptable.
• 7. Albumin \< 3.0 g/dL.
• 11. History of autoimmune disease as determined by the Investigator (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma).
• 12. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drugs used in this study or that would put the subject at high risk for treatment-related complications.
• 13. Serious pulmonary disease.
• 14. Platelet count \< 100,000 cells/mm3.
• 15. Active hepatitis.
• 16. Positive results of screening test for human immunodeficiency virus (HIV), hepatitis B virus, and/or hepatitis C virus.
• 17. Current chronic daily treatment (continuous for \> 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
• 18. Known hypersensitivity to any component of the study medication(s).
• 19. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
• 20. Participation in an investigational drug study or receiving any investigational treatment within 28 days prior to study treatment. Approved drugs for the prevention and treatment of COVID-19 are permitted.
• 21. Concurrent participation in any interventional clinical trial.
• 22. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• 23. Pregnant and nursing women.