RECRUITING

PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC intratumoral microdosing microdose injection microdosing in vivo oncology tumor microenvironment multiplexed immunohistochemistry head and neck cancer pharmacodynamic biomarkers CIVO master protocol precision oncology spatial biology

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592

Quick Facts

Study Start:2024-05-22

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06366451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 2.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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Presage Biosciences

CONTACT

800-530-5404

clinops@presagebio.com

Principal Investigator

Study Director

STUDY_DIRECTOR

Presage Biosciences

Study Locations (Sites)

UC Davis

Sacramento, California, 95817

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

University of North Carolina

Chapel Hill, North Carolina, 27599

United States

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19107

United States

Sarah Cannon Medical Center

Charleston, South Carolina, 29406

United States

Medical University of South Carolina

Charleston, South Carolina, 29407

United States

Collaborators and Investigators

Sponsor: Presage Biosciences

Study Director, STUDY_DIRECTOR, Presage Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-22

Study Completion Date2025-04

Study Record Updates

Study Start Date2024-05-22

Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

HNSCC
intratumoral microdosing
microdose injection
microdosing
in vivo oncology
tumor microenvironment
multiplexed immunohistochemistry
head and neck cancer
head and neck squamous cell carcinoma
pharmacodynamic biomarkers
CIVO
master protocol
precision oncology
spatial biology

Additional Relevant MeSH Terms

Head and Neck Squamous Cell Carcinoma