A Phase 1 / 2 Multiple-indication Biomarker, Safety, and Efficacy Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Germany
Gemeinschaftspraxis Dr. Med Bernhard Heinreich
RECRUITING
Augsburg
Charité Universitätsklinikum Berlin
RECRUITING
Berlin
St. Josef-Hospìtal, Bochum
RECRUITING
Bochum
Klinikum Chemnitz gGmbH
RECRUITING
Chemnitz
Krankenhaus Nordwest
RECRUITING
Frankfurt Am Main
Asklepios Kliniken Hamburg GmbH
RECRUITING
Hamburg
Hämatologisch-Onkologische Praxis Eppendorf
RECRUITING
Hamburg
Nationales Centrum für Tumorerkrankungen Heidelberg
RECRUITING
Heidelberg
SLK-Kliniken Heilbronn GmbH
RECRUITING
Heilbronn
Universität Leipzig
RECRUITING
Leipzig
Universitätsmedizin Mainz
RECRUITING
Mainz
Klinikum der Universität München
RECRUITING
München
Caritasklinikum Saarbrücken St. Theresia
RECRUITING
Saarbrücken
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Universitätsklinikum Ulm
RECRUITING
Ulm
Contact Information
Primary
Reference Study ID Number: REO 029 GOBLET
reo-029@oncolytics.ca
+1 (858) 247- 7829
Time Frame
Start Date:2021-10-27
Estimated Completion Date:2028-12-31
Participants
Target number of participants:122
Treatments
Experimental: Cohort 1: Metastatic Pancreatic Cancer 1L
Patients with first-line (1L) locally advanced/metastatic unresectable pancreatic ductal adenocarcinoma (PDAC): Pelareorep and atezolizumab added to gemcitabine and nab-paclitaxel
Experimental: Cohort 2: Metastatic Colorectal Cancer 1L (MSI-H/dMMR)
Patients with 1L metastatic colorectal cancer (mCRC), limited to microsatellite instability-high (MSIH) or mismatch repair deficient (dMMR) tumors: Pelareorep and atezolizumab
Experimental: Cohort 3: Metastatic Colorectal Cancer 3L
Patients with third-line (3L) mCRC independent of microsatellite instability (MSI)/dMMR status: Pelareorep and atezolizumab added to trifluridine/tipiracil
Experimental: Cohort 4: Metastatic Unresectable Anal Cancer >/=2L
Patients with \>/= 2L locally advanced/metastatic unresectable squamous cell carcinoma of the anal canal (SCCA) of viral or non-viral origin after prior systemic chemotherapy: Pelareorep and atezolizumab
Experimental: Cohort 5: Metastatic PDAC 1L
Patients with 1L metastatic PDAC: Pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab