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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
* Dose cohort 1: 1e11 virus particles (VP)/dose * Dose cohort 2: 5e11 VP/dose * If needed, dose cohort -1 (de-escalation): 5e10 VP/dose
Chan Soon-Shiong Institute for Medicine (CSSIFM)
El Segundo, California, United States
Texas Oncology Austin Central
Austin, Texas, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Determine the maximum tolerated dose of IBRX-042
The rate of DLTs will be assessed and the MTD determined
Time frame: 1 year
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.
Time frame: 2 years
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.
Time frame: 2 years
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