Not recruitingRare disease

Study of HST-1011 Alone and with Cemiplimab for Patients with Advanced Solid Tumors Not Responding to Standard Treatments

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for people with advanced solid tumors, which are types of cancer that have spread and are not responding to standard treatments. The study will explore the effects of a new medication called HST-1011, which is taken as a capsule. The trial will test different doses of HST-1011 to find the most suitable amount for patients. Additionally, the study will examine how HST-1011 works when used alone and when combined with another medication called cemiplimab, which is given through an intravenous infusion, meaning it is delivered directly into the bloodstream.

The purpose of the study is to understand the safety and tolerability of HST-1011 both as a standalone treatment and in combination with cemiplimab. Participants will receive either the new medication or a placebo, and their health will be monitored closely throughout the study. The trial will help determine the best dose and schedule for using HST-1011 in treating these cancers. The study will involve regular check-ups, including blood tests and other assessments, to ensure the safety of the participants and to gather information on how the treatment is affecting the cancer.

This trial is an important step in finding new ways to treat advanced cancers that have not responded to other therapies. By participating, patients will contribute to research that could lead to new treatment options for future patients with similar conditions. The study is expected to continue until 2025, with recruitment starting in late 2023.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Treatment Phase
The study begins with the administration of HST-1011 as a monotherapy. This involves taking capsules orally. The specific dosage and frequency will be determined based on individual needs and the study protocol.
During this phase, the focus is on assessing the initial safety and tolerability of HST-1011.
Step 2
Combination Treatment Phase
If applicable, the treatment may progress to include a combination of HST-1011 and cemiplimab. Cemiplimab is administered through an intravenous infusion.
The goal is to evaluate the safety and tolerability of the combination therapy.
Step 3
Dose Determination
Throughout the trial, the appropriate dose for the next phase of the study is determined. This involves monitoring the body's response to the medication and adjusting the dosage as necessary.
Step 4
Monitoring and Assessment
Regular assessments are conducted to monitor for any side effects or adverse reactions. This includes laboratory tests, electrocardiograms (ECGs), and physical exams.
The effectiveness of the treatment is also evaluated using imaging and other diagnostic tools.
Step 5
Completion of Treatment
The treatment phase concludes once the study objectives have been met or if it is determined that continuing the treatment is not in the best interest of the patient.
Follow-up assessments may be conducted to monitor long-term effects and overall health.

Who can join the trial?

14 criteria

The patient must be at least 18 years old.
The patient must be able to understand and follow the study requirements.
The patient must have signed a consent form approved by an ethics committee before any study-related procedures are done.
The patient must have a confirmed diagnosis of an advanced solid tumor, which means a type of cancer that has spread or cannot be removed by surgery.
The patient must have tried standard treatments for their cancer and not had more than one other treatment since their last failed therapy.
The patient must have at least one measurable tumor outside the brain that can be safely biopsied, unless otherwise approved.
The patient must agree to provide tissue samples before and during treatment, unless it is not medically possible.
The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Female patients who can have children must have a negative pregnancy test and agree to use two effective forms of birth control during the study and for four months after the last dose of the study drug.
Male patients who are sexually active with a partner who can have children must use effective birth control and not donate sperm during the study and for four months after the last dose of the study drug, or six months if they receive cemiplimab.
The patient must have stopped taking certain medications that affect the liver enzyme CYP3A4 and proton pump inhibitors, except for pantoprazole, at least 14 days before starting the study drug.
The patient must have recovered from any side effects of previous cancer treatments to a mild level, except for hair loss or long-lasting effects that are not expected to improve.
The patient must have a life expectancy of more than 12 weeks, as judged by the study doctor.

Who cannot join the trial?

10 criteria

Patients who have not been diagnosed with Advanced Solid Tumors. These are types of cancer that form in solid organs or tissues.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who are part of a vulnerable population that the study is not designed to include.
Patients who have any other medical conditions or are taking medications that might interfere with the study treatment.
Patients who are pregnant or breastfeeding, as the study may not be safe for them or their baby.
Patients who have participated in another clinical trial recently, which might affect the results of this study.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who have not provided informed consent, which means they have not agreed to participate after understanding the study details.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario De Navarra
Verified
Pamplona, Spain
Hospital Universitario Quironsalud Madrid
Verified
Pozuelo De Alarcon, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

HST-1011
is an experimental medication being studied for its safety and how well it is tolerated when used alone in patients with advanced solid tumors. The study aims to find the best dose and schedule for using this medication by itself.
Cemiplimab
is a type of medication known as an anti-PD1 antibody. It is used in this study in combination with HST-1011 to see how safe and tolerable the combination is for patients with advanced solid tumors. The study also seeks to determine the best dose and schedule for using HST-1011 together with cemiplimab.

What is already known about the treatment

HST-1011
HST-1011 is an investigational medication currently being studied in clinical trials for its potential use in treating advanced solid tumors. It is administered as a monotherapy and in combination with an anti-PD1 antibody, specifically cemiplimab. The main therapeutic indication for HST-1011 is to address advanced solid tumors, with the goal of determining its safety, tolerability, and optimal dosing schedule. The mechanism of action at the molecular level involves targeting specific pathways that may inhibit tumor growth, although detailed molecular interactions are still under investigation. HST-1011 is classified under experimental cancer therapies, and its status in medical literature is primarily within the context of ongoing clinical research.
Cemiplimab
Cemiplimab is a medication used in combination with HST-1011 in clinical trials for the treatment of advanced solid tumors. It is administered via intravenous infusion and works by blocking the PD-1 pathway, which can help the immune system recognize and attack cancer cells. Cemiplimab is already approved for certain types of cancer, such as cutaneous squamous cell carcinoma, and is being further studied for its effectiveness in combination therapies. It is classified as an immune checkpoint inhibitor, and its role in medical literature is well-established as part of cancer immunotherapy strategies.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues, such as the breast, lung, or colon, and have progressed to a more severe stage. These tumors are characterized by their ability to grow uncontrollably and potentially spread to other parts of the body. As the disease progresses, the tumors may invade nearby tissues and organs, leading to various symptoms depending on their location. The progression of advanced solid tumors can vary widely among individuals, influenced by factors such as the type of cancer, its location, and the overall health of the patient. The disease often requires comprehensive management to address the complex challenges it presents.