NCT06366451

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Presage Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Rilvegostomig	Intratumoral microdose injection by the CIVO device.
BIOLOGICAL	Volrustomig	Intratumoral microdose injection by the CIVO device.
BIOLOGICAL	Sabestomig	Intratumoral microdose injection by the CIVO device.
BIOLOGICAL	AZD9592	Intratumoral microdose injection by the CIVO device.
BIOLOGICAL	Pembrolizumab	Intratumoral microdose injection by the CIVO device.
COMBINATION_PRODUCT	AZD9592 + Rilvegostomig	Intratumoral microdose injection by the CIVO device.
COMBINATION_PRODUCT	AZD9592 + Volrustomig	Intratumoral microdose injection by the CIVO device.
COMBINATION_PRODUCT	AZD9592 + Sabestomig	Intratumoral microdose injection by the CIVO device.
COMBINATION_PRODUCT	AZD9592 + Pembrolizumab	Intratumoral microdose injection by the CIVO device.

Timeline

• Start date: 2024-05-22
• Primary completion: 2025-02-01
• Completion: 2025-04-01
• First posted: 2024-04-16
• Last updated: 2025-01-20

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study