Head and Neck CancerPhase 1/2NCT06054477
Study of ALE.C04 in Patients With Head and Neck Cancer
A Phase 1/2 study testing ALE.C04 and Pembrolizumab in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Alentis Therapeutics AG at 22 sites in 8 countries.
Trial 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 (RP2D) for ALE.C04 in combination with pembrolizumab and to assess anti-tumor activity of ALE.C04 in combination with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- ALE.C04 and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 22 sitesin 8 countries
- Study dates
- 30 Oct 2023to 12 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
22 sites in 8 countries.
22 sites in 8 countries
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Gabrail Cancer Center Research
Canton, Ohio, 44718
Karmanos Cancer Institute
Detroit, Michigan, 48201
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Washington University School of Medicine
Lake Saint Louis, Missouri, 63110
University of Southern California USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Yale University Yale Cancer Center
New Haven, Connecticut, 06510
Spain4 sites
Vall d'Hebron Institute of Oncology
Barcelona, 08035
MD Anderson Cancer Center
Madrid
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
Incliva Biomedical Research Institute - Hospital Clinico Universitario Valencia
Valencia
France3 sites
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre
Bordeaux, 33075
Oncopole Claudius Regaud, Iuct-Oncopole
Toulouse, 31059
Institut Gustave Roussy
Villejuif
Italy3 sites
Candiolo cancer Center,FPO IRCCS
Candiolo, Piedmont, 10060
Fondazione Irccs Istituto Nazionale Dei Tumori Di Milano
Milan
Istituto Europeo Di Oncologia S.R.L.
Milan, 20141
Singapore2 sites
National Cancer Centre Singapore
Singapore, 168583
Tan Tock Seng Hospital
Singapore, 308433
Canada1 site
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5
About this study
Official title: 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.
Read the 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 ALE.C04 in combination with pembrolizumab. The phase II comprises a 1:1 randomized 2 arms assessing ALE.C04 and pembrolizumab given in combination versus pembrolizumab monotherapy
- Being tested
- ALE.C04, Pembrolizumab
- Keywords
- Immunotherapy, Anti-Claudin1, ALE.C04, Phase I/II
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALE.C04Drug
Q3W
PembrolizumabDrug
Also called Keytruda
200mg Q3W
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | 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 Receives: Drug: ALE.C04; Drug: Pembrolizumab |
| Phase 1 Recommended Dose for Expansion | Experimental | Two ALE.C04 dose levels (higher or lower) will be considered for the combination with pembrolizumab Receives: Drug: ALE.C04; Drug: Pembrolizumab |
| Phase 2 Randomized Combination part | Active comparator | ALE.C04 at RP2D combined to pembrolizumab compared to pembrolizumab monotherapy Receives: Drug: ALE.C04; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicity (DLT)
Phase I dose escalation
Measured: 21 days
Incidence and severity of adverse events (AEs), serious adverse events (SAEs)
Descriptive statistics will be used to summarize results
Measured: Up to 30 days after last dose - Approximately 4.5 years
Confirmed Objective Response Rate (ORR) by investigators assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 for Phase II
Measured: Up to 4.5 year
Confirmed Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment according to RECIST1.1
Time from start of study treatment to first documentation of objective progressive disease (PD) as per RECIST1.1 or to death due to any causes whichever come first during phase II
Measured: Up to 4.5 year
Secondary outcomes (18)
Confirmed ORR by investigators assessment according to RECIST1.1
Proportion of patients with confirmed CR or PR according to RECIST1.1
Measured: up to 4.5 year
Confirmed immune Objective Response Rate (iORR) by investigators assessment according to immune RECIST
Proportion of patients with confirmed immune CR or immune PR according to immune RECIST
Measured: up to 4.5 year
Disease Control Rate (DCR) as per investigator assessment according to RECIST1.1
Proportion of patients with CR, PR or Stable Disease (SD) according to RECIST1.1
Measured: up to 4.5 years
Immune Disease Control Rate (iDCR) as per investigator assessment according to immune RECIST
Proportion of patients with immune CR, immune PR or immune SD according to immune RECIST
Measured: up to 4.5 years
Duration Of Response (DOR)
The time from first documentation of objective response to the first documentation of PD per RECIST 1.1 or to death due to any cause, whichever comes first.
Measured: up to 4.5 years
Immune Duration Of Response (iDOR)
The time from first documentation of objective response to the first documentation of immune PD per immune RECIST or to death due to any cause, whichever comes first.
Measured: up to 4.5 years
Progression Free Survival (PFS) evaluated by investigators
The time from start of study treatment to first documentation of objective PD per RECIST1.1 following study therapy, or to death due to any cause, whichever comes first.
Measured: up to 4.5 years
Immune Progression Free Survival (iPFS) evaluated by investigators
The time from start of study treatment to first documentation of objective immune PD per immune RECIST following study therapy, or to death due to any cause, whichever comes first.
Measured: up to 4.5 years
Overall Survival (OS)
The time from start of study treatment to date of death due to any cause.
Measured: up to 4.5 years
Maximum serum concentration (Cmax) pharmacokinetics (PK) of ALE.C04
Maximum serum concentration (Cmax) will be derived by non-compartmental analysis and summarized by dose cohort
Measured: up to 4.5 years
Minimum serum concentration (Cmin) pharmacokinetics (PK) of ALE.C04
Minimum serum concentration will be derived by non-compartmental analysis and summarized by dose cohort
Measured: up to 4.5 years
Area under the concentration-time curve (AUC) pharmacokinetics (PK) of ALE.C04
Area under the concentration-time curve will be derived by non-compartmental analysis and summarized by dose cohort
Measured: up to 4.5 years
Maximum serum concentration (Cmax) Pharmacokinetics (PK) of pembrolizumab
Maximun Serum concentration (Cmax) by time point will be reported
Measured: up to 4.5 years
Minimum serum concentration (Cmin) Pharmacokinetics (PK) of pembrolizumab
Minimum serum concentration (Cmin) by time point will be reported
Measured: up to 4.5 years
Area under the concentration-time curve (AUC) Pharmacokinetics (PK) of pembrolizumab
Area under the concentration-time curve (AUC) by time point will be reported
Measured: up to 4.5 years
Immunogenicity of ALE.C04
To assess the presence of serum anti-drug antibodies (ADA) against ALE.C04
Measured: up to 4.5 years
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30
The C30 has 30 items in total. Among those items, 28 items are symptoms scales with score range from 1 to 4. A high score represents a high level of symptomatology. The 2 other items are global health status with score range of 1 to 7. A high score represents high quality of life.
Measured: Phase II combination part only - Up to 4.5 year
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Question Head and Neck module 43 (HN43)
The HN43 has 43 items of symptoms scale with score range of 1 to 4. A high score represents a high level of symptomatology.
Measured: Phase II combination part only - Up to 4.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start30 Oct 2023
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Why it stopped: Reprioritization of Trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1 will consist of i) a dose escalation of ALE.C04 monotherapy evaluating approximately 3 dose levels of ALE.C04, ii) a dose escalation of ALE.C04 and pembrolizumab combination evaluating approximately 2 dose levels of ALE.C04 and iii) a randomized two RDEs evaluating two dose level of ALE.C04 combined with pembrolizumab to establish Recommended Phase 2 Dose (RP2D). 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alentis Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054477
- Sponsor's protocol ID
- ALE.C04.01
- Status last verified
- Feb 2025
- First submitted
- 7 Sep 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06054477
- Acronym / sponsor ID
- ALE.C04.01
- Keywords
- Immunotherapy, Anti-Claudin1, ALE.C04, Phase I/II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reprioritization of Trial
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Alentis Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 ALE.C04 in combination with pembrolizumab. The phase II comprises a 1:1 randomized 2 arms assessing ALE.C04 and pembrolizumab given in combination versus pembrolizumab monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1 will consist of i) a dose escalation of ALE.C04 monotherapy evaluating approximately 3 dose levels of ALE.C04, ii) a dose escalation of ALE.C04 and pembrolizumab combination evaluating approximately 2 dose levels of ALE.C04 and iii) a randomized two RDEs evaluating two dose level of ALE.C04 combined with pembrolizumab to establish Recommended Phase 2 Dose (RP2D). 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Drug: ALE.C04, Drug: PembrolizumabALE.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 |
| Phase 1 Recommended Dose for Expansion | Experimental | Drug: ALE.C04, Drug: PembrolizumabTwo ALE.C04 dose levels (higher or lower) will be considered for the combination with pembrolizumab |
| Phase 2 Randomized Combination part | Active comparator | Drug: ALE.C04, Drug: PembrolizumabALE.C04 at RP2D combined to pembrolizumab compared to pembrolizumab monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALE.C04Q3W | Drug | Phase 1 Dose Escalation, Phase 1 Recommended Dose for Expansion, Phase 2 Randomized Combination part |
| PembrolizumabAlso: Keytruda200mg Q3W | Drug | Phase 1 Dose Escalation, Phase 1 Recommended Dose for Expansion, Phase 2 Randomized Combination part |
Primary outcome
Incidence of Dose Limiting Toxicity (DLT)
Time frame: 21 days
Phase I dose escalation
Incidence and severity of adverse events (AEs), serious adverse events (SAEs)
Time frame: Up to 30 days after last dose - Approximately 4.5 years
Descriptive statistics will be used to summarize results
Confirmed Objective Response Rate (ORR) by investigators assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to 4.5 year
Proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 for Phase II
Confirmed Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment according to RECIST1.1
Time frame: Up to 4.5 year
Time from start of study treatment to first documentation of objective progressive disease (PD) as per RECIST1.1 or to death due to any causes whichever come first during phase II
18 secondary outcomes
Confirmed ORR by investigators assessment according to RECIST1.1
Time frame: up to 4.5 year
Confirmed immune Objective Response Rate (iORR) by investigators assessment according to immune RECIST
Time frame: up to 4.5 year
Disease Control Rate (DCR) as per investigator assessment according to RECIST1.1
Time frame: up to 4.5 years
Immune Disease Control Rate (iDCR) as per investigator assessment according to immune RECIST
Time frame: up to 4.5 years
Duration Of Response (DOR)
Time frame: up to 4.5 years
Immune Duration Of Response (iDOR)
Time frame: up to 4.5 years
Progression Free Survival (PFS) evaluated by investigators
Time frame: up to 4.5 years
Immune Progression Free Survival (iPFS) evaluated by investigators
Time frame: up to 4.5 years
Overall Survival (OS)
Time frame: up to 4.5 years
Maximum serum concentration (Cmax) pharmacokinetics (PK) of ALE.C04
Time frame: up to 4.5 years
Minimum serum concentration (Cmin) pharmacokinetics (PK) of ALE.C04
Time frame: up to 4.5 years
Area under the concentration-time curve (AUC) pharmacokinetics (PK) of ALE.C04
Time frame: up to 4.5 years
Maximum serum concentration (Cmax) Pharmacokinetics (PK) of pembrolizumab
Time frame: up to 4.5 years
Minimum serum concentration (Cmin) Pharmacokinetics (PK) of pembrolizumab
Time frame: up to 4.5 years
Area under the concentration-time curve (AUC) Pharmacokinetics (PK) of pembrolizumab
Time frame: up to 4.5 years
Immunogenicity of ALE.C04
Time frame: up to 4.5 years
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30
Time frame: Phase II combination part only - Up to 4.5 year
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Question Head and Neck module 43 (HN43)
Time frame: Phase II combination part only - Up to 4.5 year
Results and safety
The study was stopped early (reason given: Reprioritization of Trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALE.C04 and Pembrolizumab in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Alentis Therapeutics AG at 22 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Spain, France, Italy, Singapore and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Reprioritization of Trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicity (DLT) (time frame: 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.