RecruitingEarly Phase 1NCT06366451

PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592

Sponsor

Presage Biosciences

Enrollment

15 participants

Start Date

May 22, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma

Summary

This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, sabestomig, and AZD9592 within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma (HNSCC) with a surface accessible lesion, who are scheduled for tumor and/or regional node dissection as part of their standard treatment. PD effects due to injected investigational agents, either as single agents or as AZD9592 drug combinations with the evaluated biologics, will be compared to those elicited by pembrolizumab alone, which will also be injected in microdose quantities via the CIVO device.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a sub-study testing very small doses of four experimental cancer drugs (rilvegostomig, volrustomig, sabestomig, and AZD9592) injected directly into tumors of people with head and neck cancer, to measure how the drugs interact with tumor tissue before choosing a larger dose for future trials. **You may be eligible if...** - You are 18 or older - You have been diagnosed with head and neck squamous cell carcinoma (a type of cancer affecting the mouth, throat, or related areas) - Your tumor is accessible for biopsy and direct injection - You are enrolled in or eligible for the parent study (NCT04541108) **You may NOT be eligible if...** - You have a serious autoimmune disease - You have received certain prior treatments that conflict with the study drugs - You are pregnant or breastfeeding - Your tumor cannot be safely accessed for injection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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