IBRX-042 In Participants With HPV-Associated Tumors

NCT05976828 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: QUILT-3.100
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to determine the maximum tolerated dose and to find out the side effects of a drug called IBRX-042 at different dose levels in patients with recurrent or progressive Human Papillomavirus (HPV) associated tumors. The main questions it aims to answer are:

• What is the maximum tolerated dose of IBRX-042?
• How well does the study drug treat cancer?
• What effects the study drug may have on the human body and cancer? Participants will receive IBRX-042 at one of three dose levels every 3 weeks for a total of 3 injections. Participants will undergo tests, exams, and procedures that are part of standard of care and for study purposes. IBRX-042 will be administered by injection every 3 weeks for a total of 3 injections.

Conditions

HPV-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose of IBRX-042

  The rate of DLTs will be assessed and the MTD determined

  1 year

Secondary Outcomes (2)

• Determine the safety profile & reactogenicity of IBRX-042

  2 years

• Examine HPV-specific humoral and cellular immune responses

  2 years

Other Outcomes (1)

• Assess exploratory molecular profiles and their correlations with participant outcomes

  2 years

Study Arms (3)

First Dose Level

EXPERIMENTAL

Dose Cohort 1: IBRX -042 1e11 virus particles per dose

Drug: IBRX-042

Second Dose Level

EXPERIMENTAL

Dose Cohort 2: IBRX-042 5e11 virus particles per dose

Drug: IBRX-042

De-escalation Dose Level

EXPERIMENTAL

Dose Cohort -1: IBRX-042 5e10 virus particles per dose

Drug: IBRX-042

Interventions

IBRX-042 DRUG

* Dose cohort 1: 1e11 virus particles (VP)/dose * Dose cohort 2: 5e11 VP/dose * If needed, dose cohort -1 (de-escalation): 5e10 VP/dose

Also known as: IBRX-042 (hAd5-HPV E6.ETSD-IRES-E7.ETSD Vaccine)

De-escalation Dose Level; First Dose Level; Second Dose Level

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
• Histologically confirmed HPV-associated cancer documented as HPV- or p16-positive carcinoma (measurable or non-measurable disease).
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• 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.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• 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).
• Adequate organ function, evidenced by the following laboratory results:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Absolute lymphocyte count (ALC) \> institutional lower limit of normal
• Hemoglobin ≥ 10.0 g/dL.
• Platelet count ≥ 100 × 109/L
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome).
• 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.

You may not qualify if:

• 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.
• Serious pulmonary disease.
• Active hepatitis.
• Positive results of screening test for hepatitis B virus and/or hepatitis C virus.
• 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.
• Participants taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
• 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.
• Concurrent participation in any interventional clinical trial.
• Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• Pregnant and nursing women.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (3)

Chan Soon-Shiong Institute for Medicine (CSSIFM)

El Segundo, California, 90245, United States

Location

Texas Oncology Austin Central

Austin, Texas, 78731, United States

Location

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Study Officials

• Bobby Reddy, MD

  ImmunityBio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Determination of the MTD of IBRX-042 vaccine will utilize 3 + 3 dose escalation design. Participants will be sequentially enrolled to 1 of 3 dosing cohorts (up to 3-6 participants per arm). * Dose cohort 1: 1e11 virus particles (VP)/dose * Dose cohort 2: 5e11 VP/dose * If needed, dose cohort -1 (de-escalation): 5e10 VP/dose

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 4, 2023
• Study Start: June 14, 2024
• Primary Completion (Estimated): September 2, 2027
• Study Completion (Estimated): August 14, 2033
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)