Spots Global Cancer Trial Database for Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers
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Trial Identification
Brief Title: Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers
Official Title: A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination With Atezolizumab in Patients With Selected Advanced/Metastatic EGFR-expressing Cancers
Study ID: NCT05109442
Conditions
Study Description
Brief Summary: AFM24-102 is a Phase 1/2a open-label, non-randomized, multicenter, dose escalation, and expansion study evaluating AFM24 in combination with atezolizumab in patients with selected EGRF-expressing advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
Detailed Description: There will be 2 parts in this study: a dose escalation phase (phase 1) and an expansion phase (phase 2a). Patients will qualify to receive the investigational drugs (AFM24 + atezolizumab) in the dose escalation phase or the expansion phase only if they are deemed eligible following the safety lead-in phase. Seven days before the planned first combination treatment, patients will receive a single dose of AFM24 and will be observed for any adverse events for 1 week. The aim of the dose escalation phase is to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of AFM24 in combination with atezolizumab. The dose escalation phase will be followed by the expansion phase once the MTD/RP2D of AFM24 in combination with atezolizumab has been determined. The expansion phase of the study is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24 in combination with atezolizumab. The tumor types planned to be studied in the AFM24/atezolizumab combination study will be: * Non-small cell lung cancer (EGFR-WT), with disease progression after chemotherapy and PD1/PD-L1 targeted therapy * Gastric/GEJ cancer if intolerant to or with disease progression after standard platinum-based chemotherapy * Pancreatic/hepatocellular/biliary tract cancer with disease progression after standard of care (SOC) therapy or if there is no appropriate SOC available for their condition * Advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation with disease progression on or after received ≥1 prior lines of treatment for advanced disease, including a Tyrosine-Kinase Inhibitor (TKI) for EGFR mutations
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital, Suwon, , Korea, Republic of
Independent Public Teaching Hospital #4 in Lublin, Department of Clinical Oncology and Chemotherapy, Lublin, , Poland
European Health Center Otwock Fryderyk Chopin Hospital, Department of Clinical Oncology, Otwock, , Poland
MED-Polonia, Sp. z o.o. (LLC), Poznań, , Poland
Janusz Korczak Provincial Specialist Hospital in Slupsk Limited Liability Company, Słupsk, , Poland
Maria Sklodowska-Curie - National Research Institute of Oncology, Early Phase Research Department, Warsaw, , Poland
Vall d'Hebron Institute of Oncology (VHIO), Barcelona, , Spain
University Hospital Quiron Madrid, Madrid, , Spain
University Clinic of Navarra - Pamplona, Pamplona, , Spain
Hospital Clinic Universitario Biomedical Research institute INCLIVA, Valencia, , Spain
Royal Marsden NHS Foundation Trust - ICR, Sutton, , United Kingdom
Contact Details
Name: Daniela Morales-Espinosa, MD
Affiliation: Affimed GmbH
Role: STUDY_DIRECTOR
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