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

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ClinicalTrials.gov Identifier: NCT06054477
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Alentis Therapeutics AG

Study Description
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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 (RP2D) for ALE.C04 in combination with pembrolizumab and as monotherapy and to assess anti-tumor activity of ALE.C04 monotherapy and in combination with pembrolizumab in patients with Head and Neck Cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Drug: ALE.C04 Drug: Pembrolizumab Phase 1 Phase 2

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 both ALE.C04 monotherapy and in combination with pembrolizumab. The phase II comprises a 1:1 randomized 2 arms assessing 2 dose levels of ALE.C04 as monotherapy and a 1:1 randomized 2 arms assessing ALE.C04 and pembrolizumab given in combination versus pembrolizumab monotherapy
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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) one Recommended Dose for Expansion (RDE) evaluating one dose level of ALE.C04 monotherapy aiming to detect anti-tumor activity of ALE.C04 single agent and iv) 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 i) ALE.C04 randomized part evaluating two dose levels of the single agent to establish RP2D and ii) A randomized part comparing ALE.C04 (at the RP2D dose determined in the phase 1) combined to pembrolizumab with pembrolizumab alone.
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
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
Actual Study Start Date : October 30, 2023
Estimated Primary Completion Date : February 2028
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: ALE.C04
Q3W

Drug: Pembrolizumab
200mg Q3W
Other Name: Keytruda
Experimental: Phase 1 Recommended Dose for Expansion
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
 Drug: ALE.C04
Q3W

Drug: Pembrolizumab
200mg Q3W
Other Name: Keytruda
Active Comparator: Phase 2 Randomized Combination part
ALE.C04 at RP2D combined to pembrolizumab compared to pembrolizumab monotherapy
 Drug: ALE.C04
Q3W

Drug: Pembrolizumab
200mg Q3W
Other Name: Keytruda
Experimental: Phase 2 Randomized Monotherapy part
ALE.C04 monotherapy (DL1 Q3W) ALE.C04 monotherapy (DL2 Q3W)
 Drug: ALE.C04
Q3W


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: 21 days ]
    Phase I dose escalation

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Confirmed ORR by investigators assessment according to RECIST1.1 [ Time Frame: up to 4.5 year ]
    Proportion of patients with confirmed CR or PR according to RECIST1.1

  2. Confirmed immune Objective Response Rate (iORR) by investigators assessment according to immune RECIST [ Time Frame: up to 4.5 year ]
    Proportion of patients with confirmed immune CR or immune PR according to immune RECIST

  3. Disease Control Rate (DCR) as per investigator assessment according to RECIST1.1 [ Time Frame: up to 4.5 years ]
    Proportion of patients with CR, PR or Stable Disease (SD) according to RECIST1.1

  4. Immune Disease Control Rate (iDCR) as per investigator assessment according to immune RECIST [ Time Frame: up to 4.5 years ]
    Proportion of patients with immune CR, immune PR or immune SD according to immune RECIST

  5. Duration Of Response (DOR) [ Time Frame: up to 4.5 years ]
    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.

  6. Immune Duration Of Response (iDOR) [ Time Frame: up to 4.5 years ]
    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.

  7. Progression Free Survival (PFS) evaluated by investigators [ Time Frame: up to 4.5 years ]
    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.

  8. Immune Progression Free Survival (iPFS) evaluated by investigators [ Time Frame: up to 4.5 years ]
    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.

  9. Overall Survival (OS) [ Time Frame: up to 4.5 years ]
    The time from start of study treatment to date of death due to any cause.

  10. Maximum serum concentration (Cmax) pharmacokinetics (PK) of ALE.C04 [ Time Frame: up to 4.5 years ]
    Maximum serum concentration (Cmax) will be derived by non-compartmental analysis and summarized by dose cohort

  11. Minimum serum concentration (Cmin) pharmacokinetics (PK) of ALE.C04 [ Time Frame: up to 4.5 years ]
    Minimum serum concentration will be derived by non-compartmental analysis and summarized by dose cohort

  12. Area under the concentration-time curve (AUC) pharmacokinetics (PK) of ALE.C04 [ Time Frame: up to 4.5 years ]
    Area under the concentration-time curve will be derived by non-compartmental analysis and summarized by dose cohort

  13. Maximum serum concentration (Cmax) Pharmacokinetics (PK) of pembrolizumab [ Time Frame: up to 4.5 years ]
    Maximun Serum concentration (Cmax) by time point will be reported

  14. Minimum serum concentration (Cmin) Pharmacokinetics (PK) of pembrolizumab [ Time Frame: up to 4.5 years ]
    Minimum serum concentration (Cmin) by time point will be reported

  15. Area under the concentration-time curve (AUC) Pharmacokinetics (PK) of pembrolizumab [ Time Frame: up to 4.5 years ]
    Area under the concentration-time curve (AUC) by time point will be reported

  16. Immunogenicity of ALE.C04 [ Time Frame: up to 4.5 years ]
    To assess the presence of serum anti-drug antibodies (ADA) against ALE.C04

  17. 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 ]
    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.

  18. 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 ]
    The HN43 has 43 items of symptoms scale with score range of 1 to 4. A high score represents a high level of symptomatology.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be willing and able to provide written informed consents
  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:

  1. Has progressive disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC (Phase II randomized combination part only).
  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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054477


Contacts
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Contact: Luigi Manenti, MD 41782304288 ale.c04.01@alentis.ch

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Alentis Therapeutics         
United States, California
University of Southern California USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Alentis Therapeutics         
United States, Connecticut
Yale University Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
Contact: Alentis Therapeutics         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Alentis Therapeutics         
United States, Missouri
Washington University School of Medicine Recruiting
Lake Saint Louis, Missouri, United States, 63110
Contact: Alentis Therapeutics         
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Alentis Therapeutics         
Canada, Ontario
University Health Network, Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Alentis Therapeutics         
Hong Kong
Prince Of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Alentis Therapeutics         
Italy
Candiolo cancer Center,FPO IRCCS Recruiting
Candiolo, Piedmont, Italy, 10060
Contact: Alentis Therapeutics         
Fondazione Irccs Istituto Nazionale Dei Tumori Di Milano Recruiting
Milan, Italy
Contact: Alentis Therapeutics         
Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 168583
Contact: Alentis Therapeutics         
Tan Tock Seng Hospital Recruiting
Singapore, Singapore, 308433
Contact: Alentis Therapeutics         
Spain
MD Anderson Cancer Center Recruiting
Madrid, Spain
Contact: Alentis Therapeutics         
Hospital Clínico Universitario de Santiago de Compostela Recruiting
Santiago De Compostela, Spain
Contact: Alentis Therapeutics         
Incliva Biomedical Research Institute - Hospital Clinico Universitario Valencia Recruiting
Valencia, Spain
Contact: Alentis Therapeutics         
Sponsors and Collaborators
Alentis Therapeutics AG
More Information
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Responsible Party: Alentis Therapeutics AG
ClinicalTrials.gov Identifier: NCT06054477    
Other Study ID Numbers: ALE.C04.01
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alentis Therapeutics AG:
Immunotherapy
Anti-Claudin1
ALE.C04
Phase I/II
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action