Testing IBRX-042 in patients with HPV-related tumors

QUILT-3.100: Phase 1 Open-Label Study to Evaluate Safety And Determine The Maximum Tolerated Dose of IBRX-042 In Participants With HPV-Associated Tumors.

This study is testing a new drug called IBRX-042 to see if it can help people with HPV-related tumors and how much of it they can safely take.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: ImmunityBio, Inc. (Industry-sponsored)
• Locations: 3 sites (El Segundo, California and 2 other locations)
• Trial ID: NCT05976828 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the maximum tolerated dose of IBRX-042 and assess its effects on patients with recurrent or progressive HPV-associated tumors. Participants will receive the drug via injection every three weeks for a total of three doses, while undergoing standard tests and procedures. The study will evaluate how well the drug treats cancer and monitor any side effects experienced by the participants. Up to 60 patients may be screened, with 18 expected to receive the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed HPV-associated cancer who have previously received standard care.

Not a fit: Patients with non-HPV-related cancers or those who have not completed prior therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HPV-related cancers.

How similar studies have performed: While this approach is novel, similar studies targeting HPV-related tumors have shown promise in the past.

Eligibility criteria

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.

Exclusion Criteria:

1. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drugs used in this study or that would put the participant at high risk for treatment-related complications.
2. Serious pulmonary disease.
3. Active hepatitis.
4. Positive results of screening test for hepatitis B virus and/or hepatitis C virus.
5. 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 participants who have known contrast allergies is allowed.
6. Participants taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
7. 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.
8. Concurrent participation in any interventional clinical trial.
9. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
10. Pregnant and nursing women.

Where this trial is running

El Segundo, California and 2 other locations

• Chan Soon-Shiong Institute for Medicine (CSSIFM) — El Segundo, California, United States (Recruiting)
• Texas Oncology Austin Central — Austin, Texas, United States (Recruiting)
• The University of Texas - MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Raymond S Atiata

Conditions HPV-Related Carcinoma