Study of ALE.C04 in Patients With Head and Neck Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

In brief

The purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and to assess anti-tumor activity of ALE.C04 in combination with pembrolizumab in patients with Head and Neck Cancer.

Key facts

Study ID

NCT06054477

Run by

Alentis Therapeutics AG

People needed

21

Starts

2023-10-30

Expected to finish

2025-02-12

Last updated by the study team

2025-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be willing and able to provide written informed consents
• Be 18 years of age on day of signing informed consent.
• Have histologically or cytologically confirmed Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) that is considered incurable by local therapies.
• Have provided tissue for claudin-1 (CLDN1), programmed death ligand-1 (PD-L1) and biomarker analysis in a central Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
• Have measurable disease based on RECIST 1.1 as determined by the site.
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
• Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer

You may not qualify if…

• Has progressive disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC (Phase II randomized combination part only).
• Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to randomization or patient has not fully recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered treatment. Palliative radiotherapy to a limited field is allowed.
• Severe immune-related adverse events leading to discontinuation of prior immune-oncology agent only for Phase I dose escalation monotherapy and combination and Phase II monotherapy.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Dermatological conditions requiring active pharmacological treatment including psoriasis, atopic dermatitis, excessively dry skin or recurrent conjunctivitis, scleroderma, vitiligo, or any other active autoimmune dermatological disorder.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
• Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1 or anti-PD-L2 (Phase II randomized combination part only).

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• University of Southern California USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Yale University Yale Cancer Center — New Haven, Connecticut, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University School of Medicine — Lake Saint Louis, Missouri, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• University Health Network, Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre — Bordeaux, France
• Oncopole Claudius Regaud, Iuct-Oncopole — Toulouse, France
• Institut Gustave Roussy — Villejuif, France
• Prince Of Wales Hospital — Hong Kong, Hong Kong
• Candiolo cancer Center,FPO IRCCS — Candiolo, Piedmont, Italy
• Fondazione Irccs Istituto Nazionale Dei Tumori Di Milano — Milan, Italy
• Istituto Europeo Di Oncologia S.R.L. — Milan, Italy
• National Cancer Centre Singapore — Singapore, Singapore
• Tan Tock Seng Hospital — Singapore, Singapore
• Vall d'Hebron Institute of Oncology — Barcelona, Spain
• MD Anderson Cancer Center — Madrid, Spain
• Hospital Clínico Universitario de Santiago de Compostela — Santiago de Compostela, Spain
• Incliva Biomedical Research Institute - Hospital Clinico Universitario Valencia — Valencia, Spain
• Inselspital, University Hospital Bern — Bern, Switzerland

Full record on ClinicalTrials.gov

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