Clinical trial · Interventional
EMD 1201081 + 5-FU + Cisplatin + Cetuximab in Subjects With Recurrent / Metastatic Squamous Cell Carcinoma of the Head and Neck
Phase Ib Trial of Multiple-ascending Doses of EMD 1201081 in Combination With 5-FU/Cisplatin and Cetuximab in First-line Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to potential safety concerns in combination with platinum-based therapies
Summary
Brief summary (as posted)
The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EMD 1201081 + 5-FU + Cisplatin + Cetuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 (Part 1)
- interventionNames
- Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab
- type
- EXPERIMENTAL
- label
- Arm 2 (Expansion cohorts -Part 2 and Part 2a)
- interventionNames
- Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab
Primary outcomes (4)
- measure
- Maximum-tolerated-dose (MTD) at 0.16 mg/kg cohort size testing
- timeFrame
- 3 weeks
- description
- Occurrence of treatment-related dose-limiting toxicity during the first cycle (3 weeks) of treatment in subjects treated with multi-ascending doses of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN). * Recurrent and/or metastatic SCCHN, not suitable for local therapy. * At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0). * Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry. Exclusion Criteria: * Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry. * Nasopharyngeal carcinoma. * Medical history of diagnosed interstitial lung disease. * Known hypersensitivity against any of the components of the trial treatment. * Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed). * Relevant cardiovascular co-morbidities. * Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent. * Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B.
References
Publications (0)
Data not yet available