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Back|NCT04541108Recruiting
Official Title

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

Phase
Early Phase 1
Sponsor
Presage Biosciences
Enrollment
15
Timeline
Jul 2021 → Dec 2031
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Ability and willingness to comply with the study's visit and assessment schedule.
  • 2Male or female ≥ 18 years of age at Visit 1 (Screening).
  • 3Pathologic diagnosis of \[solid tumors\] indicated in the relevant substudy(ies).
  • 4Ability 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
  • 5At 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.
  • 6Female patients who:
  • 7Are postmenopausal for at least one year before the screening visit, OR
  • 8Are surgically sterile, OR
  • 9Are 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.
  • 10Agree to refrain from donating ova during study participation.
  • 11Male patients, even if surgically sterile (i.e., status post-vasectomy), who:
  • 12Agree to practice effective barrier contraception from the time of signing the ICF and during study participation OR agree to completely abstain from heterosexual intercourse.
  • 13Agree to refrain from donating sperm during study participation.

Exclusion Criteria

  • 1Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient.
  • 2Female patients who are:
  • 3Both lactating and breastfeeding, OR
  • 4Have a positive β-subunit human chorionic gonadotropin (β-hCG) pregnancy test at screening verified by the Investigator.
  • 5Any 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.

Locations

12 sites participating in this study

Emory Winship Cancer Institute

Atlanta, Georgia 30308

Recruiting

Mihir Patel, MD

UC Davis

Sacramento, California 95817

Recruiting

Arnaud Bewley, MD

LSU Health Sciences Center - Shreveport

Shreveport, Louisiana 71115

Recruiting

Research Coordinator

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →