Combining AFM24 with Atezolizumab for Advanced EGFR-expressing Cancers
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
This study is testing a new combination of two cancer treatments, AFM24 and atezolizumab, to see if they can help people with advanced cancers that have not responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Affimed GmbH Industry-sponsored |
| Drugs / interventions | Osimertinib, Lazertinib, chemotherapy, Radiation, atezolizumab |
| Locations | 16 sites (Los Angeles, California and 15 other locations) |
| Trial ID | NCT05109442 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of AFM24 in combination with atezolizumab for patients with advanced or metastatic EGFR-expressing cancers that have progressed after prior treatments. It consists of two phases: a dose escalation phase to determine the maximum tolerated dose and a subsequent expansion phase to gather preliminary efficacy data. Patients will receive AFM24 followed by atezolizumab, with close monitoring for adverse events. The study focuses on various cancer types, including non-small cell lung cancer and gastric cancer.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced or metastatic EGFR-positive cancers who have progressed after previous treatments.
Not a fit: Patients with early-stage cancers or those who have not received prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could provide a new treatment option for patients with advanced EGFR-expressing cancers that have limited effective therapies.
How similar studies have performed: Other studies have shown promise in combining targeted therapies with immunotherapy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 trated 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 Exclusion Criteria: * 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 this trial is running
Los Angeles, California and 15 other locations
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Seoul National University Bundang Hospital — Seongnam-si, Korea, Republic of (Recruiting)
- Severance Hospital, Yonsei University Health System — Seoul, Korea, Republic of (Recruiting)
- The Catholic University of Korea St. Vincent's Hospital — Suwon, Korea, Republic of (Recruiting)
- Independent Public Teaching Hospital #4 in Lublin, Department of Clinical Oncology and Chemotherapy — Lublin, Poland (Recruiting)
- European Health Center Otwock Fryderyk Chopin Hospital, Department of Clinical Oncology — Otwock, Poland (Recruiting)
- MED-Polonia, Sp. z o.o. (LLC) — Poznań, Poland (Recruiting)
- Janusz Korczak Provincial Specialist Hospital in Slupsk Limited Liability Company — Słupsk, Poland (Recruiting)
- Maria Sklodowska-Curie - National Research Institute of Oncology, Early Phase Research Department — Warsaw, Poland (Recruiting)
- Vall d'Hebron Institute of Oncology (VHIO) — Barcelona, Spain (Recruiting)
- University Hospital Quiron Madrid — Madrid, Spain (Recruiting)
- University Clinic of Navarra - Pamplona — Pamplona, Spain (Recruiting)
- Hospital Clinic Universitario Biomedical Research institute INCLIVA — Valencia, Spain (Recruiting)
- Royal Marsden NHS Foundation Trust - ICR — Sutton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Affimed GmbH
- Email: trials@affimed.com
- Phone: +49 621 56003-0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.