🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT07280377
Active, not recruiting Phase 1/2

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

NCT07280377 · tracked via the Priya Life Science Germany tracker
Phase
Phase 1/2
Started
2021-10-27
Last updated
2026-05-19

Condition(s) studied

Anal Cancer MetastaticSquamous Cell Carcinoma of the Anus Stage UnspecifiedPancreatic Cancer MetastaticUnresectable Pancreatic Carcinoma

Investigational drug(s) / intervention(s)

Pelareorep →Atezolizumab →Gemcitabine and nab-paclitaxel →Trifluridine Tipiracil →mFOLFIRINOX Treatment Regimen

Pelareorep: Pelareorep 4.5 x 10\^10 TCID50 via 1-hour IV infusion

Atezolizumab: Atezolizumab 840 mg IV infusion

Gemcitabine and nab-paclitaxel: Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2)

Trifluridine Tipiracil: Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily

mFOLFIRINOX Treatment Regimen: 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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Nationales Centrum für Tumorerkrankungen Heidelberg Heidelberg Baden-Wurttemberg
SLK-Kliniken Heilbronn GmbH Heilbronn Baden-Wurttemberg
Universitätsklinikum Tübingen Tübingen Baden-Wurttemberg
Universitätsklinikum Ulm Ulm Baden-Wurttemberg
Gemeinschaftspraxis Dr. Med Bernhard Heinreich Augsburg Bavaria
Klinikum der Universität München München Bavaria
Hämatologisch-Onkologische Praxis Eppendorf Hamburg Free and Hanseatic City of Hamburg
Asklepios Kliniken Hamburg GmbH Hamburg Free and Hanseatic City of Hamburg
Krankenhaus Nordwest Frankfurt am Main Hesse
St. Josef-Hospìtal, Bochum Bochum North Rhine-Westphalia
Universitätsmedizin Mainz Mainz Rhineland-Palatinate
Caritasklinikum Saarbrücken St. Theresia Saarbrücken Saarland
Klinikum Chemnitz gGmbH Chemnitz Saxony
Universität Leipzig Leipzig Saxony
Charité Universitätsklinikum Berlin Berlin State of Berlin

On this site

📄 Tecentriq (atezolizumab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07280377 on ClinicalTrials.gov ↗ ← All trials in Germany