Actively Recruiting
PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC
Led by Presage Biosciences · Updated on 2025-01-20
15
Participants Needed
7
Research Sites
44 weeks
Total Duration
On this page
Sponsors
P
Presage Biosciences
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to provide written informed consent before any study procedures
- Male or female aged 18 years or older at screening
- Pathologic diagnosis of Head and Neck Squamous Cell Carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx
- Ability and willingness to comply with study visits and assessments
- At least one tumor or lymph node lesion surface accessible for CIVO injection with viable tumor tissue and planned surgery
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Female patients must be postmenopausal for at least one year, surgically sterile, or agree to effective contraception or abstinence from signing consent until 7 months after injection
- Female patients must agree to avoid donating or retrieving ova and refrain from breastfeeding until 7 months after injection
- Male patients must agree to use effective barrier contraception or abstain from heterosexual intercourse and avoid fathering a child or donating sperm until 7 months after injection
You will not qualify if you...
- Tumors or nodes lacking sufficient viable tumor tissue for microdose injection due to necrosis, cysts, fibrosis, or treatment changes
- Tumors near critical structures where injection poses undue risk
- Prior immune-mediated therapy including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies within the last 5 years
- Previous treatment with certain antibody drug conjugates targeting topoisomerase 1 or EGFR/c-MET
- Concurrent cancer, immune disease, or active infection requiring systemic therapy or radiotherapy
- Female patients who intend pregnancy, are lactating and breastfeeding, or have a positive pregnancy test at screening
- Any uncontrolled or serious medical or psychiatric illness that may interfere with study adherence
- History of organ transplant
- Major surgery within 4 weeks prior to injection without adequate healing and recovery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
UC Davis
Sacramento, California, United States, 95817
Actively Recruiting
2
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
4
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Not Yet Recruiting
5
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
6
Sarah Cannon Medical Center
Charleston, South Carolina, United States, 29406
Actively Recruiting
7
Medical University of South Carolina
Charleston, South Carolina, United States, 29407
Actively Recruiting
Research Team
P
Presage Biosciences
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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