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HPV-Related CarcinomaPhase 1NCT05976828

IBRX-042 In Participants With HPV-Associated Tumors

A Phase 1 study testing IBRX-042 in people with HPV-Related Carcinoma, run by ImmunityBio, Inc. at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HPV-Related Carcinoma
What is being tested?
IBRX-042
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
14 Jun 2024to 14 Aug 2033
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 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.
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  • 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.
  • Albumin ≥ 3.0 g/dL. Note: Each study site should use its institutional ULN to determine eligibility.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Chan Soon-Shiong Institute for Medicine (CSSIFM)

    El Segundo, California, 90245

  • The University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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.

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.

Read the detailed description

Up to 60 participants may be screened for up to 18 participants to receive at least 1 dose of study treatment. Participants will be administered IBRX-042 by injection once every 3 weeks for a total of 3 injections.

Participants will receive study treatments until they report progressive disease (PD), unacceptable toxicity, withdraw consent, or if the Investigator feels it is no longer in their best interest to continue treatment.

Participants who progress, discontinue treatment, or complete the study will attend an end-of- treatment (EOT) visit 30 (± 5) days after the last administration of study treatment.

Additionally, participants will attend a follow-up visit 6 months following administration of the last dose of IBRX-042. After the participants completes or withdraws from the study, the study team will contact participants approximately every 3 months for a minimum of 1 year post administration of the first dose of study drug and then yearly until death to collect follow-up information, including survival status, collection of adverse events, and any current cancer treatment regimen. A clinic visit will be scheduled for 6 months after the last injection administered for collection of whole blood for exploratory immune and molecular profiling.

Being tested
IBRX-042

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBRX-042Drug

    Also called IBRX-042 (hAd5-HPV E6.ETSD-IRES-E7.ETSD Vaccine)

    • 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 groups in NCT05976828
Study groupRoleWhat they receive
First Dose LevelExperimentalDose Cohort 1: IBRX -042 1e11 virus particles per dose
Receives: Drug: IBRX-042
Second Dose LevelExperimentalDose Cohort 2: IBRX-042 5e11 virus particles per dose
Receives: Drug: IBRX-042
De-escalation Dose LevelExperimentalDose Cohort -1: IBRX-042 5e10 virus particles per dose
Receives: Drug: IBRX-042

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the maximum tolerated dose of IBRX-042

    The rate of DLTs will be assessed and the MTD determined

    Measured: 1 year

Secondary outcomes (2)

  1. Determine the safety profile & reactogenicity of IBRX-042

    Overall safety will be assessed by the incidence of adverse events including: treatment-emergent MAAEs, SAEs, solicited local and systemic reactogenicity AEs, and unsolicited AEs. Adverse Events will be qualified by the time periods of interest, overall and by grade. Adverse events (AEs) will be summarized by System Organ Class (SOC) and Medical Dictionary for Regulatory Activities (MedDRA) preferred term. All AEs will be graded using CTCAE Version 5.0. The incidence of clinically significant changes in safety laboratory tests, physical examinations, ECGs, and vital signs will also be presented.

    Measured: 2 years

  2. Examine HPV-specific humoral and cellular immune responses

    Summary statistics from analyses of the humoral and cellular immune response endpoints will be provided. Where applicable, geometric mean titers (GMTs) and their associated 95% confidence intervals (CIs) will be computed by exponentiation of the corresponding log-transformed means and 95% CIs. Correlations of humoral and cellular immune response with participants outcomes will be provided.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study start14 Jun 2024
  3. Primary completion2 Sep 2027 (estimated)
  4. Study completion14 Aug 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05976828
Sponsor's protocol ID
QUILT-3.100
Status last verified
Aug 2026
First submitted
18 Jul 2023
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBRX-042 in people with HPV-Related Carcinoma, run by ImmunityBio, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the maximum tolerated dose of IBRX-042 (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05976828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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