A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592
Presage Biosciences
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.
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 wi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Ability and willingness to provide written informed consent. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 2. Male or female ≥ 18 years of age at Visit 1 (Screening). 3. Pathologic diagnosis of Head and Neck Squamous Cell Carcinoma (HNSCC) of the oropharynx, hypopharynx, oral cavity, or larynx. 4. Ability and willingness to comply with the study's visits and assessment sch…
Interventions
- BiologicalRilvegostomig
Intratumoral microdose injection by the CIVO device.
- BiologicalVolrustomig
Intratumoral microdose injection by the CIVO device.
- BiologicalSabestomig
Intratumoral microdose injection by the CIVO device.
- BiologicalAZD9592
Intratumoral microdose injection by the CIVO device.
- BiologicalPembrolizumab
Intratumoral microdose injection by the CIVO device.
- Combination ProductAZD9592 + Rilvegostomig
Intratumoral microdose injection by the CIVO device.
- Combination Product
Locations (7)
- UC DavisSacramento, California
- Montefiore Medical CenterThe Bronx, New York
- University of North CarolinaChapel Hill, North Carolina
- Oregon Health & Science University (OHSU)Portland, Oregon
- University of PennsylvaniaPhiladelphia, Pennsylvania
- Sarah Cannon Medical CenterCharleston, South Carolina