RECRUITING

Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies

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Conditions

Solid TumorHNSCCSCCHNlymphomasarcomabreast adenocarcinomamelanomaintratumoral microdosingmicrodose injectionmicrodosingin vivo oncologyin vivo drug sensitivitytumor microenvironmentmultiplexed immunohistochemistryhead and neck cancerpharmacodynamic biomarkersCIVOmaster protocolprecision oncologysoft tissue sarcoma

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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 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients with surface accessible solid tumors for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated.

Official Title

A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Anti-Cancer Therapies in Patients With Solid Tumors

Quick Facts

Study Start:2021-07-26
Study Completion:2031-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04541108

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 CriteriaExclusion Criteria
  1. 1. Ability and willingness to comply with the study's visit and assessment schedule.
  2. 2. Male or female ≥ 18 years of age at Visit 1 (Screening).
  3. 3. Pathologic diagnosis of \[solid tumors\] indicated in the relevant substudy(ies).
  4. 4. 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
  5. 5. At least one lesion (primary tumor, recurrent tumor, 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. 6. Female patients who:
  7. * Are postmenopausal for at least one year before the screening visit, OR
  8. * Are surgically sterile, OR
  9. * Are of childbearing potential who agree to practice a highly effective method of contraception from the time of signing the Informed Consent Form (ICF) and during study participation OR agree to completely abstain from heterosexual intercourse.
  10. * Agree to refrain from donating ova during study participation.
  11. * Agree to practice effective barrier contraception from the time of signing the ICF and during study participation OR agree to completely abstain from heterosexual intercourse.
  12. * Agree to refrain from donating sperm during study participation.
  1. 1. Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient.
  2. 2. Female patients who are:
  3. * Both lactating and breastfeeding, OR
  4. * Have a positive β-subunit human chorionic gonadotropin (β-hCG) pregnancy test at screening verified by the Investigator.
  5. 3. 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.

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
Emory Winship Cancer Institute
Atlanta, Georgia, 30308
United States
LSU Health Sciences Center - Shreveport
Shreveport, Louisiana, 71115
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
UC Health
Cincinnati, Ohio, 45229
United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
United States
Sarah Cannon Research Institute
Charleston, South Carolina, 29406
United States
UT Health
Houston, Texas, 77030
United States
University of Washington
Seattle, Washington, 98109
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 Date2021-07-26
Study Completion Date2031-12

Study Record Updates

Study Start Date2021-07-26
Study Completion Date2031-12

Terms related to this study

Keywords Provided by Researchers

  • HNSCC
  • SCCHN
  • lymphoma
  • sarcoma
  • breast adenocarcinoma
  • melanoma
  • intratumoral microdosing
  • microdose injection
  • microdosing
  • in vivo oncology
  • in vivo drug sensitivity
  • tumor microenvironment
  • multiplexed immunohistochemistry
  • head and neck cancer
  • pharmacodynamic biomarkers
  • CIVO
  • master protocol
  • precision oncology
  • soft tissue sarcoma

Additional Relevant MeSH Terms

  • Solid Tumor