Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2023-10-30
2025-02-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Phase 2 will consist of a 1:1 randomized 2 arms comparing ALE.C04 (at the RP2D dose determined in the phase 1) combined to pembrolizumab with pembrolizumab alone.
TREATMENT
NONE
Study Groups
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Phase 1 Dose Escalation
ALE.C04 single agent: Three planned doses of ALE.C04 and ALE.C04 in combination with pembrolizumab. Once a certain dose level of ALE.C04 is considered safe and well tolerated, the first cohort of patients receiving ALE.C04 at a lower dose level combined with pembrolizumab will be initiated
ALE.C04
Q3W
Pembrolizumab
200mg Q3W
Phase 1 Recommended Dose for Expansion
Two ALE.C04 dose levels (higher or lower) will be considered for the combination with pembrolizumab
ALE.C04
Q3W
Pembrolizumab
200mg Q3W
Phase 2 Randomized Combination part
ALE.C04 at RP2D combined to pembrolizumab compared to pembrolizumab monotherapy
ALE.C04
Q3W
Pembrolizumab
200mg Q3W
Interventions
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ALE.C04
Q3W
Pembrolizumab
200mg Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be 18 years of age on day of signing informed consent.
3. Have histologically or cytologically confirmed Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) that is considered incurable by local therapies.
4. 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.
5. Have measurable disease based on RECIST 1.1 as determined by the site.
6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
7. Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
Exclusion Criteria
2. 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.
3. 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.
4. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
5. 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.
6. 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.
7. Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1 or anti-PD-L2 (Phase II randomized combination part only).
18 Years
ALL
No
Sponsors
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Alentis Therapeutics AG
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ALE.C04.01
Identifier Type: -
Identifier Source: org_study_id
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