A Window-of-opportunity Study of Pelareorep in Early Breast Cancer

Sponsor
Oncolytics Biotech
Study ID
NCT04102618
Phase
EARLY_PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Pelareorep — BIOLOGICAL
    4.5 × 10e10 TCID50 administered intravenously on Days 1, 2, 8 \& 9
  • Letrozole — DRUG
    Oral dose of 2.5 mg/day starting on Day 3 for 13 days
  • Atezolizumab — DRUG
    1200 mg administered intravenously on Day 3
  • Trastuzumab — DRUG
    8mg/kg administered intravenously or 600mg subcutaneously on Day 3

Study Details

The purpose of this study is to find out if pelareorep in combination with different therapies helps to reduce the growth of breast cancer cells and increase the immune system's response to cancer. This study will also help to understand what this treatment does to the tumor. In addition, the safety of the combination treatments with pelareorep will be evaluated.

Key Dates

Start date
Mar 29, 2019
Status verified
Aug 2022
Primary completion
Apr 20, 2022
Completion
Apr 20, 2022

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (closed to enrollment)
    HR+/HER2-neg patients who will receive pelareorep plus letrozole
  • Experimental: Cohort 2 (closed to enrollment)
    HR+/HER2-neg patients who will receive pelareorep plus letrozole plus atezolizumab
  • Experimental: Cohort 3 (closed to enrollment)
    TNBC patients who will receive pelareorep plus atezolizumab
  • Experimental: Cohort 4 (closed to enrollment)
    HER2+/HR+ patients who will receive pelareorep plus trastuzumab plus atezolizumab
  • Experimental: Cohort 5 (closed to enrollment)
    HER2+/HR- patients who will receive pelareorep plus trastuzumab plus atezolizumab
  • Experimental: Cohort 6
    HER2+ (irrespective of HR status) (6 patients) who will receive pelareorep + trastuzumab

Primary Outcome Measure

To evaluate if pelareorep in combination with different therapies increases the value of the CelTIL score in women with operable early breast cancer. CelTIL is a combined IHC-based score based on tumor cellularity and stromal TILs. [ Time Frame: The CelTIL score will be measured from on-treatment tumor biopsies collected at baseline (pre-treatment), day 3, and at time of surgery (day ~21 ± 5 days). ]

Related Studies