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Monoclonal Antibodies
Pembrolizumab + ALE.C04 for Head and Neck Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Alentis Therapeutics AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 years of age on day of signing informed consent.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to evaluate the safety and effectiveness of a drug combination for Head and Neck Cancer.
Who is the study for?
This trial is for adults with incurable recurrent or metastatic head and neck squamous cell carcinoma. Participants must be able to consent, have measurable disease per RECIST 1.1, an ECOG performance status of 0 or 1, and provide tissue samples for specific biomarker analysis.
What is being tested?
The study is testing ALE.C04 alone and combined with pembrolizumab in patients with head and neck cancer. It aims to determine the safety profile, how the body processes ALE.C04, the recommended dose for Phase II trials, and its effectiveness against tumors.
What are the potential side effects?
While not explicitly listed here, side effects may include typical reactions seen with immunotherapy such as fatigue, skin reactions, inflammation in organs like lungs or intestines (colitis), hormonal gland issues (endocrinopathies), infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My oropharyngeal cancer has been tested for HPV.
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My head or neck cancer has returned or spread and cannot be cured with surgery or radiation.
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I have given a tissue sample for specific cancer marker tests in a certified lab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4.5 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Confirmed Objective Response Rate (ORR) by investigators assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Confirmed Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment according to RECIST1.1
Incidence and severity of adverse events (AEs), serious adverse events (SAEs)
+1 moreSecondary study objectives
Area under the concentration-time curve (AUC) Pharmacokinetics (PK) of pembrolizumab
Area under the concentration-time curve (AUC) pharmacokinetics (PK) of ALE.C04
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Question Head and Neck module 43 (HN43)
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Phase 1 Recommended Dose for ExpansionExperimental Treatment2 Interventions
Two ALE.C04 dose levels (higher or lower) will be considered for the combination with pembrolizumab
Group II: Phase 1 Dose EscalationExperimental Treatment2 Interventions
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
Group III: Phase 2 Randomized Combination partActive Control2 Interventions
ALE.C04 at RP2D combined to pembrolizumab compared to pembrolizumab monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3130
Find a Location
Who is running the clinical trial?
Alentis Therapeutics AGLead Sponsor
2 Previous Clinical Trials
121 Total Patients Enrolled