IBRX-042 In Participants With HPV-Associated Tumors

Inclusion 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 non-measurable disease).
• •4. Participants must have received at least 1 standard of care therapy per National Comprehensive Cancer Network (NCCN) guidelines for their HPV-associated cancer \> 28 days prior to enrollment.
• •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• •6. 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.
• •7. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• •8. Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of child-bearing potential must agree to use effective contraception for up to 30 days after last dose of study treatment. Nonsterile male participants must agree to use a condom while on study and for up to 30 days after the last dose of study treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, and intrauterine devices (IUDs).
• •9. 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 participant 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. Note: Each study site should use its institutional ULN to determine eligibility.