Trackable Intratumor Microdosing and Spatial Profiling Provide Early Insights into Activity of Investigational Agents in the Intact Tumor Microenvironment.
Jonathan M J Derry, Connor Burns, Jason P Frazier...
https://pubmed.ncbi.nlm.nih.gov/37389981Actively Recruiting
Early Phase 1
Age: 18Years +
All Genders
ID06366451
A Phase 0 Study of Intratumoral Microdose Effects of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in Head and Neck Squamous Cell Carcinoma
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
Researchers are investigating the localized effects of several investigational drugs—rilvegostomig, volrustomig, sabestomig, and AZD9592—on the tumor environment in patients with Head and Neck Squamous Cell Carcinoma (HNSCC). This Phase 0, open-label, multicenter study compares these investigational agents, delivered alone or in combination, to pembrolizumab, a drug commonly used in this patient group. The goal is to understand how these drugs influence tumor biology when given in very small doses directly into accessible tumors. During the study, patients receive microdose injections of the investigational biologics and combinations using the CIVO Microdose Injection Device directly into their tumors. Up to eight different drugs or combinations can be injected simultaneously into a single tumor to observe their effects. The drugs are administered intratumorally in microdose amounts shortly before patients undergo planned surgical removal of the tumor or affected lymph nodes. Participants will be closely monitored between 1 to 3 days after injection, with tissue samples analyzed for drug responses at the injection sites. Researchers will assess gene activity changes within the tumor microenvironment to evaluate pharmacodynamic effects. Participants must be willing to undergo required visits and assessments, including surgery as part of their standard care. The study focuses on safety, drug effects, and biomarker responses within the tumor tissue after localized microdosing.
CONDITIONS
Official Title
PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC
Who Can Participate
Age: 18Years +
All Genders
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
1
2
3
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
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Research Team
P
Presage Biosciences
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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