Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Arnaud Bewley, MD (ucdavis)

Description

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.

Official Title

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

Details

The CIVO Microdose Injection Device (MID) simultaneously delivers multiple drugs and drug combinations (Up to 8), each in microdose amounts, into a single patient tumor and enables comparisons of the resulting biomarker responses that occurred while that tumor was still in the native microenvironment. AstraZeneca is developing three novel assets: rilvegostomig, volrustomig, and sabestomig, all of which are bispecific monoclonal antibodies designed to stimulate antitumor immunity. In this Phase 0 clinical trial, the PD effects of these investigational assets in the TME of patients presenting with HNSCC will be evaluated. These investigational assets will be injected alone in microdose quantities at tumor sites in HNSCC patients. Pembrolizumab, also used therapeutically in this patient population, will be included in the CIVO injection array administered as a single agent. In addition, microdoses of AZD9592, a novel antibody drug conjugate (ADC), alone or in combinations with the evaluated biologics will also be assessed. The CIVO-injected portion of the tissue will be analyzed for localized response at sites of drug exposure in the TME.

Keywords

Head and Neck Squamous Cell Carcinoma, HNSCC, intratumoral microdosing, microdose injection, microdosing, in vivo oncology, tumor microenvironment, multiplexed immunohistochemistry, head and neck cancer, pharmacodynamic biomarkers, CIVO, master protocol, precision oncology, spatial biology, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Pembrolizumab, Rilvegostomig, Volrustomig, Sabestomig, AZD9592, AZD9592 + Rilvegostomig, AZD9592 + Volrustomig, AZD9592 + Sabestomig, AZD9592 + Pembrolizumab, Rilvegostomig, Volrustomig, Sabestomig, AZD9592, Pembrolizumab

Eligibility

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • Oregon Health & Science University (OHSU) not yet accepting patients
    Portland Oregon 97239 United States
  • Sarah Cannon Medical Center accepting new patients
    Charleston South Carolina 29406 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Presage Biosciences
ID
NCT06366451
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated