Phase IbII Study of Afatinib Treatment in Adults with Fanconi Anemia and Unresectable or Metastatic Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating Afatinib, an EGFR tyrosine kinase inhibitor, in patients with Fanconi Anemia who have locoregionally unresectable or metastatic head and neck squamous cell carcinoma HNSCC. This phase IbII, single-arm, non-randomized, open-label multicenter study aims to determine the safety and effectiveness of Afatinib as a treatment for this specific patient group, addressing the need for options in this challenging cancer type. Participants will receive Afatinib starting at 20 mg daily during the first two weeks. If tolerated without significant toxicities, the dose will be increased to 30 mg daily for weeks 3 and 4, and then to 40 mg daily from week 5 onward. Dose escalations depend on the absence of hematologic or other relevant side effects. This treatment schedule continues throughout the study period. Throughout the trial, participants will be regularly monitored for tumor response using imaging scans, with the main measure being the objective response rate at 9 months after starting treatment. Additional assessments include disease control rate, duration of response, survival rates, patient-reported quality of life questionnaires, and tracking of severe toxicities. Patients organ and bone marrow functions will be checked, and safety will be closely observed during the study, which is expected to last at least 9 months.

Afatinib in Patients With Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)