A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab
A Phase 1 / 2 Multiple-indication Biomarker, Safety, and Efficacy Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab
Oncolytics Biotech
122 participants
Oct 27, 2021
INTERVENTIONAL
Conditions
Summary
This is an open-label, phase 1/2, multiple-indication platform study to explore safety, potential predictive immune-related biomarkers, and early efficacy (as measured by objective response rate \[ORR; Cohorts 1,2, 4,and 5\] and disease control rate \[DCR; Cohort 3\]) in patients with advanced or metastatic gastrointestinal (GI) tumors. Cohorts 1-4 are not randomized; however, Cohort 5 is comprised of two treatment arms to which patients are randomized in a 1:1 ratio.
Eligibility
Inclusion Criteria5
- ECOG performance status of 0 or 1
- Have measurable lesions per RECIST v1.1
- Patients must have adequate hematological, renal, and hepatic function
- Have recovered to ≤grade 1 or baseline for all adverse events (AEs) due to previous therapies or surgeries.
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use a highly-effective form(s) of contraception and to continue its use for 6 months after the last dose of study drug.
Exclusion Criteria19
- Undergone systemic chemotherapy, radiotherapy, or surgery, \<4 weeks before study treatment.
- Received previous treatment with immune checkpoint inhibitors
- Uncontrolled or severe cardiac disease
- Active, uncontrolled infections
- Symptomatic brain metastasis
- Interstitial lung disease with symptoms or signs of activity.
- Autoimmune disease that has required systemic treatment in the past 2 years with disease modifying agents, corticosteroids, or immunosuppressive drugs.
- A seizure disorder that requires pharmacotherapy.
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- A non-healing wound, non-healing ulcer, or non-healing bone fracture within 4 weeks prior to the start of study drug.
- Women who are pregnant or breastfeeding.
- A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy
- Any vaccine within 28 days prior to first treatment or during the first cycle of study treatment.
- In Cohort 1, 2, 3, 4: Life expectancy less than 3 months
- In Cohort 1, 2, 3: known active Hepatitis B (HBV) or Hepatitis C (HCV) infection that requires anti-viral treatment.
- In Cohort 4: Prior HIV infection if the CD4+ T cell is \<300 cells/µl
- In Cohort 5: Known low or absent dihydropyrimidine dehydrogenase (DPD) activity.
- In Cohort 5: Known leptomeningeal disease.
- In Cohort 5: History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ
Interventions
Pelareorep 4.5 x 10\^10 TCID50 via 1-hour IV infusion
Atezolizumab 840 mg IV infusion
Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2)
Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily
mFOLFIRINOX- IV oxaliplatin 85 mg/m2; IV leucovorin 400 mg/m2; IV irinotecan 150 mg/m2; 5-FU 2400 mg/m2 by 46-hour infusion, per local standard of care
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT07280377