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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

Study 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.Check my eligibility

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.See study design

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

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 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2 Randomized Monotherapy partExperimental Treatment1 Intervention

ALE.C04 monotherapy (DL1 Q3W) ALE.C04 monotherapy (DL2 Q3W)

Group II: Phase 1 Recommended Dose for ExpansionExperimental Treatment2 Interventions

One dose of ALE.C04 will be considered (dose identified from Phase 1 Dose Escalation part) Two ALE.C04 dose levels (higher or lower) will be considered for the combination with pembrolizumab

Group III: 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 IV: 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 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alentis Therapeutics AGLead Sponsor

2 Previous Clinical Trials

98 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical centers are currently conducting the trial?

"Presently, enrolment is available at 5 medical facilities located in Detroit, Lake Saint Louis and Canton as well as two other locations. To minimise travel needs, it would be prudent to select the nearest site when signing up for this research project."

Answered by AI

How many participants are being accepted for this clinical exploration?

"To begin the study, 220 qualified participants must be recruited. Individuals can apply to volunteer at either Karmanos Cancer Institute in Detroit or Washington University School of Medicine located in Lake Saint Louis."

Answered by AI

Are there any open slots available for this clinical trial?

"Affirmative. The clinical trial's website on clinicaltrials.gov states that, since October 30th 2023, the study has been accepting patients and is now searching for 220 participants across 5 distinct locations."

Answered by AI

What is the intended outcome of this experiment?

"According to Alentis Therapeutics AG, the study's sponsor, the primary outcome evaluated over a span of 4.5 years is Confirmed Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR). Additionally, secondary outcomes including Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Question Head and Neck module 43 (HN43), Immune Disease Control Rate (iDCR) according to immune RECIST, and Duration Of Response(DOR) will also be measured."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of ALE.C04 in Patients With Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06054477.