IBRX-042 In Subjects With HPV-Associated Tumors

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial Description

Up to 60 subjects may be screened for up to 18 subjects to receive at least 1 dose of study drug. Subjects will be administered IBRX-042 by injection once every 3 weeks for a total of 3 injections. Subjects 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. Subjects who progress, discontinue treatment, or complete the study will attend an end-of-treatment (EOT) visit 30 days after the last study assessment. Additionally, subjects will attend a follow-up visit 6 months following administration of the last dose of IBRX-042. After the subject completes or withdraws from the study, the study team will contact subjects 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 Design

Related Conditions & MeSH terms

HPV-Related Carcinoma

Clinical Trial Details

NCT number	NCT05976828
Study type	Interventional
Source	ImmunityBio, Inc.
Contact	Natalie Fernandez
Phone	7862618816
Email	natalie.fernandez@immunitybio.com
Status	Not yet recruiting
Phase	Phase 1
Start date	June 14, 2024
Completion date	August 14, 2033

View Details

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