NCT05976828

IBRX-042 In Participants With HPV-Associated Tumors

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.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HPV-Related Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-14
• Primary completion: 2027-09-02
• Completion: 2033-08-14
• First posted: 2023-08-04
• Last updated: 2025-10-20

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study