Intratumoral microdosing of new cancer treatments for head and neck cancer
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592
This study is testing if small doses of new cancer treatments can help boost the immune response in patients with head and neck cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Presage Biosciences Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 7 sites (Sacramento, California and 6 other locations) |
| Trial ID | NCT06366451 on ClinicalTrials.gov |
What this trial studies
This multi-center, open-label Phase 0 substudy evaluates the pharmacodynamics of rilvegostomig, volrustomig, sabestomig, and AZD9592 when administered intratumorally in microdose quantities using the CIVO device in patients with Head and Neck Squamous Cell Carcinoma (HNSCC). The study aims to compare the effects of these investigational agents, both alone and in combination with pembrolizumab, on the tumor microenvironment. Patients with surface-accessible lesions scheduled for tumor dissection will receive these microdoses, allowing for localized response analysis in the tumor tissue. The goal is to assess how these treatments stimulate antitumor immunity within the native tumor environment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a pathologically confirmed diagnosis of HNSCC and a surface-accessible lesion suitable for microdosing.
Not a fit: Patients with non-surface accessible tumors or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of cancer treatments by providing targeted therapy directly within the tumor microenvironment.
How similar studies have performed: While the approach of intratumoral microdosing is innovative, similar studies have shown promise in enhancing localized treatment responses.
Eligibility criteria
Show full inclusion / exclusion criteria
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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 2.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 schedule. 5. At least one lesion (primary tumor, recurrent tumor, metastasis, or metastatic lymph node) that is surface accessible for CIVO injection that contains viable minimum tumor tissue volume and characteristics (e.g., based on clinical evaluation, available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports indicating lesion with appropriate viable tumor volume without excessive cysts or necrosis) and for which there is a planned surgical intervention. The patient's presentation, surgical and pathology plan may determine whether a lesion is eligible with respect to a given CIVO MID needle configuration. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. Female patients who: * Are postmenopausal for at least one year before the screening visit, OR * Are surgically sterile, OR * Are of childbearing potential who agree to practice a highly effective method of contraception from the time of signing the Informed Consent Form (ICF) until 7 months after the CIVO injection OR agree to completely abstain from heterosexual intercourse. * Agree to refrain from donating, or retrieving for their own use, ova until 7 months after the CIVO injection. * Agree to refrain from breastfeeding until 7 months after the CIVO injection. 8. Male patients, even if surgically sterile (i.e., status post-vasectomy), who: * Agree to practice effective barrier contraception from the time of signing the ICF until 7 months after the CIVO injection OR agree to completely abstain from heterosexual intercourse. * Agree to refrain from fathering a child or donating sperm until 7 months after the CIVO injection. Exclusion Criteria: 1. Tumors and/or effaced nodes that are anticipated by the Investigator to lack a sufficient volume of viable tumor tissue (Based on available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports) for CIVO microdose injection due to necrosis, cysts, excessive stroma, fibrosis, or treatment-induced tissue changes. 2. Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient. 3. Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies within the last 5 years. 4. Previous treatment with another ADC containing a chemotherapeutic agent that inhibits topoisomerase 1 activity or with another epidermal growth factor receptor (EGFR) and/or mesenchymal-epithelial transition factor (c-MET) targeted ADC. 5. Patients with concurrent cancer, immune disease or active infection requiring systemic or radiotherapy. 6. Female patients who: * Intend to become pregnant during the study, * Are both lactating and breastfeeding, OR * Have a positive beta-subunit human chorionic gonadotropin (beta-hCG) pregnancy test at screening verified by the Investigator. 7. Any uncontrolled intercurrent illness, condition, serious medical or psychiatric illness, or circumstance that, in the opinion of the Investigator, could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives. 8. History of organ transplant. 9. Major surgery within 4 weeks prior to injection: subject must have adequate wound healing and have recovered from any prior surgery.
Where this trial is running
Sacramento, California and 6 other locations
- UC Davis — Sacramento, California, United States (Recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
- Oregon Health & Science University (OHSU) — Portland, Oregon, United States (Not_yet_recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Sarah Cannon Medical Center — Charleston, South Carolina, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Presage Biosciences
- Email: clinops@presagebio.com
- Phone: 800-530-5404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.