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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Hospital Quironsalud Barcelona Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
15.11.2023

Trial locations

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.

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.

Trial ID:
2023-503731-18-00
Protocol code:
Clin-001
NCT ID:
NCT05662397
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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