Study for recurrent or metastatic head and neck squamous cell carcinoma
Location trial
- Gender Both
- Age from 18 up to and including 99
About the study
Scientists are looking for new ways to treat head and neck cancer. This study tests a new potential treatment option using an investigational drug called ALE.C04. It will be tested in people who have a certain type of head and neck cancer called Head and Neck Squamous Cell Carcinoma, or HNSCC.
The purpose of this Phase 1/2 study is to find out whether treatment with ALE.C04 alone or in combination with Keytruda® (pembrolizumab, an approved drug for HNSCC) is safe and effective. This study does not have a placebo group.
Can I participate in the study?
All participants in the study must:
- be at least 18 years old
- have been told by a doctor that they have squamous cell carcinoma of the oral cavity, throat, or voice box (larynx)
- have had anti-PD1 treatment, for example Keytruda® (pembrolizumab) or Opdivo® (nivolumab)
- have been told that their disease has come back (recurrence or relapse) or has spread to other parts of the body (metastatic disease)
How is the study set up
Screening
Before the study drugs are given, participants go through a series of tests called screening. Based on the outcomes of these tests the investigator decides if a patient can be treated as part of the study. You can always decide at any time and for any reason not to participate or stop participating in the study.
Treatment
During this period participants receive treatment with either ALE.C04 alone or ALE.C04 in combination with Keytruda®. Participants receive study medication as long as they respond to the study treatment.
Different tests and assessments will be done before and during treatment. These tests will give researchers information about the safety and efficacy of the study drug(s).
Follow-up
After the treatment period, participants might visit the study center once more. Thereafter, you will be contacted by the study center to follow up on how you are doing.
For more detailed information about the study visit clinicaltrials.gov
About the study drugs
ALE.C04 is a novel investigational drug developed by Alentis Therapeutics for the treatment of HNSCC. It is a monoclonal antibody targeting Claudin-1, a protein that is often present in HNSCC tumors. In this study, ALE.C04 is tested alone as well as in combination with an approved drug called Keytruda®. Both treatments are given as fluid through a thin tube in a vein (intravenous administration) at the study center.
Frequently asked questions
- What is a clinical trial?
- Clinical research studies (or clinical trials) are medical investigations of potential new medications. Regulatory authorities (such as the Food and Drug Administration) use these studies to help them decide if they should approve a new medication. Clinical research studies need volunteers to help researchers learn more about potential new medications.
- Clinical research studies (or clinical trials) are medical investigations of potential new medications. Regulatory authorities (such as the Food and Drug Administration) use these studies to help them decide if they should approve a new medication. Clinical research studies need volunteers to help researchers learn more about potential new medications.
- What are the different types of clinical trials?
- Each new drug has to go through several phases of clinical research before it can be approved. Generally, there are 3 Phases; Phase 1 to test safety and dosage in a small group of participants, Phase 2 to test efficacy and side effects in a medium-sized group of participants and Phase 3 to test efficacy and monitoring of adverse reactions in a large group of participants. In some cases, phases can be combined. In this particular study, Phase 1 and Phase 2 are combined.
- Each new drug has to go through several phases of clinical research before it can be approved. Generally, there are 3 Phases; Phase 1 to test safety and dosage in a small group of participants, Phase 2 to test efficacy and side effects in a medium-sized group of participants and Phase 3 to test efficacy and monitoring of adverse reactions in a large group of participants. In some cases, phases can be combined. In this particular study, Phase 1 and Phase 2 are combined.
- Is a clinical trial safe?
- Every clinical trial plan is reviewed and approved by a committee of doctors and other experts (the Food and Drug Administration and the Institutional Review Board) to ensure the plan is scientifically sound and the rights and welfare of participants are protected. Any drug, approved or not, may cause side effects. During the trial, the Institutional Review Board and the Food and Drug Administration monitor the results and step in if needed to protect participants in case of safety concerns.
- Every clinical trial plan is reviewed and approved by a committee of doctors and other experts (the Food and Drug Administration and the Institutional Review Board) to ensure the plan is scientifically sound and the rights and welfare of participants are protected. Any drug, approved or not, may cause side effects. During the trial, the Institutional Review Board and the Food and Drug Administration monitor the results and step in if needed to protect participants in case of safety concerns.
- How often do I need to visit the study center?
- You will visit the study center for a screening visit and every 3 weeks during treatment. Some additional visits are planned to collect blood samples and to monitor your health and your disease in between treatments. After treatment is stopped, you might visit the study center once more for a follow-up visit.
- You will visit the study center for a screening visit and every 3 weeks during treatment. Some additional visits are planned to collect blood samples and to monitor your health and your disease in between treatments. After treatment is stopped, you might visit the study center once more for a follow-up visit.
- How long does a visit take?
- The screening visit will take around one full day. The first 3 times you receive treatment, you will need to be at the hospital for a full day including additional visits that evening and the next day. You do not have to stay overnight unless the investigator thinks that is necessary. Other visits take around half a day.
- The screening visit will take around one full day. The first 3 times you receive treatment, you will need to be at the hospital for a full day including additional visits that evening and the next day. You do not have to stay overnight unless the investigator thinks that is necessary. Other visits take around half a day.
- How will I know the study drug is helping me?
- The investigator will monitor your tumor through scans. On the scans, they will be able to see if treatment is working.
- The investigator will monitor your tumor through scans. On the scans, they will be able to see if treatment is working.
- Will I still see my own doctor?
- You may always discuss your options with your local doctor. Your participation in the study does not prevent you from visiting your local doctor.
- You may always discuss your options with your local doctor. Your participation in the study does not prevent you from visiting your local doctor.
- Can I leave the clinical trial after it has started?
- Participation in the study is voluntary, you can leave the trial at any time and for any reason.
- Participation in the study is voluntary, you can leave the trial at any time and for any reason.
- Will there be a cost associated with study participation?
- No, the treatments given during the study are provided at no cost.
- No, the treatments given during the study are provided at no cost.
- Will my (travel) expenses be reimbursed?
- Reimbursement is offered for reasonable expenses associated with the study visits, including travel, parking, meals, etc. as agreed by the Institutional Review Board.
Australia
Balgarija
België
Canada
Česko
Chile
China (中国)
Colombia
Danmark
Deutschland
England
España
France
Ireland
Italiana
Lietuva
Magyarország
Nederland
New Zealand
Österreich
Polska
Schweiz
Singapore
Slovenija
Slovensko
Suomi
Sverige
United States
Israel