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IBRX-042 In Participants With HPV-Associated Tumors

NCT05976828 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-10-20

No results posted yet for this study

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

Interventions

DRUG

IBRX-042

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

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Bobby Reddy, MD · ImmunityBio, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-14
Primary Completion
2027-09-02
Completion
2033-08-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05976828 on ClinicalTrials.gov