Status:
RECRUITING
A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab
Lead Sponsor:
Oncolytics Biotech
Collaborating Sponsors:
Crolll Gmbh
AIO-Studien-gGmbH
Conditions:
Anal Cancer Metastatic
Squamous Cell Carcinoma of the Anus Stage Unspecified
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
The overall aim is to assess safety, predictive biomarkers, and preliminary efficacy as assessed by tumor response criteria at week 16 for cohorts1, 2, 3, and 4, and best overall response rate and OS ...
Eligibility Criteria
Inclusion
- Cohorts 1-5
- 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
- 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.
Key Trial Info
Start Date :
October 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT07280377
Start Date
October 27 2021
End Date
December 31 2028
Last Update
December 12 2025
Active Locations (15)
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1
Nationales Centrum für Tumorerkrankungen Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
SLK-Kliniken Heilbronn GmbH
Heilbronn, Baden-Wurttemberg, Germany, 74078
3
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076
4
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081