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

Part of paid clinical trials in Shreveport, Louisiana.

Sponsor
Presage Biosciences
Study ID
NCT04541108
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rilvegostomig — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device.
  • Volrustomig — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device.
  • Sabestomig — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device.
  • Pembrolizumab — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device.
  • AZD9592 — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device
  • AZD9592 + Rilvegostomig — COMBINATION_PRODUCT
    Intratumoral microdose injection by the CIVO device
  • AZD9592 + Volrustomig — COMBINATION_PRODUCT
    Intratumoral microdose injection by the CIVO device
  • AZD9592 + Sabestomig — COMBINATION_PRODUCT
    Intratumoral microdose injection by the CIVO device
  • AZD9592 + Pembrolizumab — COMBINATION_PRODUCT
    Intratumoral microdose injection by the CIVO device

Study Details

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.

Key Dates

Start date
Jul 26, 2021
Status verified
May 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Rilvegostomig, Volrustomig, Sabestomig, AZD9592, Pembrolizumab
    HNSCC patients presenting with a surface accessible lesion who are scheduled for tumor and/or regional node dissection as part of their standard treatment will be injected one to three days prior to surgery using the CIVO device. The planned injection scheme includes: vehicle control and microdoses of rilvegostomig, volrustomig, sabestomig, AZD9592, and pembrolizumab as single agents and AZD9592 drug combinations with the evaluated biologics.

Primary Outcome Measure

Quantification of Selected Pharmacodynamic Biomarkers as Specified in Substudies by IHC, ISH, and/or Spatial Biology Platforms [ Time Frame: 4 hours-7 days after microdose injection ]

Locations (9)

FacilityCityStateZIPSite coordinators
LSU Health Sciences Center - ShreveportShreveportLouisiana71115-
Montefiore Medical CenterThe BronxNew York10467-
University of North CarolinaChapel HillNorth Carolina27599-
UC HealthCincinnatiOhio45229-
Oregon Health & Science University (OHSU)PortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19107-
MUSC Hollings Cancer CenterCharlestonSouth Carolina29425-
Sarah Cannon Research InstituteCharlestonSouth Carolina29406-
University of WashingtonSeattleWashington98109-

Find similar trials in Shreveport, LA

By research site
LSU Health Sciences Center - Shreveport· Shreveport, LAMontefiore Medical Center· The Bronx, NYUniversity of North Carolina· Chapel Hill, NCUC Health· Cincinnati, OHOregon Health & Science University (OHSU)· Portland, ORUniversity of Pennsylvania· Philadelphia, PA

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