Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID06648096

Phase Ib/II Study of Afatinib for Fanconi Anemia Patients With Unresectable or Metastatic Advanced Squamous Cell Carcinoma of the Head and Neck

Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2026-05-27

25

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

F

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Lead Sponsor

M

MFAR Clinical Research S.L.

Collaborating Sponsor

AI-Summary

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 Ib/II, 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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent obtained before any study procedure
  • Age 18 years or older
  • Confirmed diagnosis of Fanconi anemia
  • Histologically or cytologically confirmed unresectable or locoregionally advanced squamous cell carcinoma of the head and neck regions including oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, paranasal sinuses, or salivary glands
  • Tumor not suitable for surgery due to location or extent
  • At least one measurable lesion by CT or MRI as per RECIST v1.1
  • Previous anticancer treatment allowed if completed 6 weeks or 5 half-lives before study
  • ECOG performance status less than 2
  • Adequate organ and bone marrow function as defined by specified blood counts and lab values
  • Female participants must be non-childbearing or agree to pregnancy prevention measures
  • Male participants must agree to prevent sperm donation and use contraception if applicable
  • Not participating in another interventional study during treatment
Not Eligible

You will not qualify if you...

  • Candidates for curative surgery
  • Less than two weeks from major surgery at treatment start
  • Prior treatment with EGFR inhibitors or investigational agents for HNSCC within 4 weeks
  • Unresolved toxicity greater than grade 2 from previous treatments
  • Other active cancers within past 2 years except certain non-melanoma skin or prostate cancers
  • Active severe infection including HIV or chronic Hepatitis B or C
  • History of recent serious cardiac events or significant arrhythmias
  • QTc interval over 470 msec
  • History of interstitial lung disease or pneumonitis
  • Gastrointestinal conditions affecting drug absorption or chronic diarrhea
  • Known allergy to Afatinib or its components
  • Pregnant or breastfeeding females
  • Inability to comply with the study protocol
  • Participation in conflicting clinical trials
  • Other medical or psychiatric conditions interfering with treatment or monitoring

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - At least 9 months

Participants receive Afatinib starting at 20 mg for the first 2 weeks, escalating to 30 mg for weeks 3-4, and then to 40 mg from week 5 onwards if no significant toxicities occur.

Visits every 8 weeks for health-related quality of life assessments until tumor recurrence

Trial Site Locations

Total: 2 locations

1

Medizinische Hochschule Hannover

Hanover, Germany

Actively Recruiting

2

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Actively Recruiting

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Research Team

A

A Responsible Person Designated by the Sponsor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Opening of a phase Ib/II study to investigate the safety and efficacy of Afatinib in patients with Fanconi anemia and unresectable locally advanced or metastatic head and neck squamous cell carcinoma.

Georgia Anguera, Oscar Gallego, Mireia Llobet...

https://pubmed.ncbi.nlm.nih.gov/40859225