Status:
TERMINATED
Study of ALE.C04 in Patients With Head and Neck Cancer
Lead Sponsor:
Alentis Therapeutics AG
Conditions:
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
The study comprises a phase I and a phase II. The phase I dose escalation part for both ALE.C04 monotherapy and in combination with pembrolizumab and a recommended dose for expansion (RDE) part for AL...
Eligibility Criteria
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 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).
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06054477
Start Date
October 30 2023
End Date
February 12 2025
Last Update
February 17 2025
Active Locations (22)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
University of Southern California USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Yale University Yale Cancer Center
New Haven, Connecticut, United States, 06510
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114