Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT05109442

Run by

Affimed GmbH

People needed

112

Starts

2021-11-19

Expected to finish

2025-06-11

Last updated by the study team

2025-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed advanced or metastatic EGFR-positive selected cancer types (except for NSCLC)
• Advanced or metastatic NSCLC, EGFR WT: disease has progressed after ≥ 1 prior lines of therapy which must have included a platinum-based doublet in combination with PD1/PD-L1 antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet
• Advanced, unresectable, or metastatic gastric/GEJ adenocarinoma: after ≥ 1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet
• Advanced or metastatic HCC (BCLC C or B not amenable or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma: after ≥1 prior line of an approved SOC therapy for the respective disease type or to whom the available SOC is not appropriate in the opinion of the investigator
• Advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥ prior TKI approved for EGFR mutated NSCLC. Subjects treated with a 1st or 2nd generation TKI in 1st line who developed a documented T790M mutation must have received a TKI targeting this mutation such as Osimertinib or Lazertinib to be eligible. Subjects must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulation free tumor DNA. The patients should have received a 2nd line of treatment if approved and available or may be enrolled in the study if in the opinion of the investigator it is in the patient's best interest,or the SOC is not appropriate.
• Adequate organ function
• Phase 1: Evaluable or measurable disease per RECIST v1.1
• Phase 2a: Measurable disease per RECIST v1.1

You may not qualify if…

• Treatment with systemic anticancer therapy including investigational agent within 4 weeks of the first dose of study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indication.
• Radiation therapy within 2 weeks before 1st dose of study drug or unresolved toxicity from previous radiotherapy
• History of any other malignancy known to be active, with the exception of completely removed in situ cervical intra-epithelial neoplasia, non-melanoma skin cancer, DCIS, early stage prostate cancer that has been adequately treated, and other cancers from which the patient has been disease free for 3 years or longer
• Currently active in any other clinical study, or administration of other investigational agent

Where it is running

• 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
• 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) — Poznan, 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
• Seoul National University Bundang Hospital — Seongnam-si, South Korea
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• The Catholic University of Korea St. Vincent's Hospital — Suwon, South Korea
• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.