A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab

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

Cohorts 1-5 Inclusion Criteria:

* 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 Criteria:

* 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.

Exclusion Criteria:

* 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

Conditions5

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