Study of ALE.C04 in Patients With Head and Neck Cancer
Reason given: Reprioritization of Trial
Key facts
- Where
- Boston, Canton, Detroit, Gilbert, Lake Saint Louis, Los Angeles, and New Haven, United StatesSee the 7 sites
- Phase
- Phase 1/2
Where in United States
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Gabrail Cancer Center ResearchCanton, United StatesNo longer taking part
- Karmanos Cancer InstituteDetroit, United StatesNo longer taking part
- Banner MD Anderson Cancer CenterGilbert, United StatesNo longer taking part
- Washington University School of MedicineLake Saint Louis, United StatesNo longer taking part
- University of Southern California (USC) - Norris Comprehensive Cancer CenterLos Angeles, United StatesNo longer taking part
- Yale University, Yale Cancer CenterNew Haven, United StatesNo longer taking part
Trial details
- Who runs it
- Alentis Therapeutics AG
- Trial code
- NCT06054477
- Record updated
- 17 February 2025
- Original description
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.Read full original descriptionShow less
A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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.
Inclusion: 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.
Exclusion: 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 received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1 or anti-PD-L2 (Phase II randomized combination part only); Has progressive disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC (Phase II randomized combination part only); 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 known active central nervous system (CNS) metastases and/or carcinomatous meningitis.