Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy

NCT ID: NCT01417936

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-10-31

Brief Summary

The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN.

Symphogen was the sponsor for planning/conducting and reporting results for this trial.

Conditions

Carcinoma, Squamous Cell of Head and Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sym004

Group Type: EXPERIMENTAL

Sym004

Intervention Type: DRUG

Sym004 will be administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.

Interventions

Sym004

Sym004 will be administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
• Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation
• Previous treatment with an anti-EGFR monoclonal antibody (mAb) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:

• Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on the anti-EGFR mAb-based therapy and
• Documented disease progression (verified by computed tomography [CT] scan or magnetic resonance imaging [MRI] according to RECIST (1.1) during or within 12 weeks following the last administration of anti-EGFR mAb
• Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies

Exclusion Criteria

• More than 2 lines of prior chemotherapy in the palliative setting
• Expected survival <12 weeks
• Subjects with known brain metastases
• Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
• Anti-EGFR mAbs within 14 days prior to Visit 2
• Major surgery within 4 weeks prior to Visit 2 and subjects must have recovered from effects of major surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Symphogen A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan Horak, MD, FACP

Role: STUDY_DIRECTOR

Symphogen A/S

Locations

3203; Antwerp University Hospital; Department of Medical Oncology

Antwerp, Edegem, Belgium

3202; Jules Bordet Institute; Clinique d'Oncologie Médicale

Brussels, , Belgium

3201; Cliniques Universitaires St-Luc; Centre du Cancer

Brussels, , Belgium

3303; Centre Alexis Vautrin; Département d'Oncologie Médicale

Nancy, Vandoeuvre Les Nancy, France

4905; Charité Campus Benjamin Franklin; Hematology, Oncology and Transfusion Medicine

Berlin, , Germany

4901; Universitätsklinikum Essen

Essen, , Germany

4904; Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

4906; University Medical Center Hamburg Eppendorf; Department of Otorhinolaryngology and Head and Neck Surgery

Hamburg, , Germany

4907; University Hospital Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, , Germany

4902; University of Leipzig

Leipzig, , Germany

Countries

Belgium; France; Germany

References

Machiels JP, Specenier P, Krauss J, Dietz A, Kaminsky MC, Lalami Y, Henke M, Keilholz U, Knecht R, Skartved NJ, Horak ID, Pamperin P, Braun S, Gauler TC. A proof of concept trial of the anti-EGFR antibody mixture Sym004 in patients with squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol. 2015 Jul;76(1):13-20. doi: 10.1007/s00280-015-2761-4. Epub 2015 May 8.

Reference Type: DERIVED

PMID: 25952795 (View on PubMed)

Other Identifiers

2011-000902-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Sym004-02

Identifier Type: -

Identifier Source: org_study_id