Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody

This research study is testing a new medicine, HST-1011, for adults who have advanced solid tumours. This means cancers that have spread or can't be removed with surgery. The study is particularly for people whose cancer has either come back or hasn't responded well to standard treatments, including certain common cancer immunotherapies known as anti-PD1/PD-L1 treatments. The study will look at how safe the new medicine is and if it helps to shrink tumours. Some patients will receive HST-1011 by itself, while others will receive it alongside another approved cancer medicine called cemiplimab. This is a very early-stage study, aiming to find the best dose and see if the new medicine could be a promising treatment option in the future.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

HotSpot Therapeutics, Inc

Enrolment target

Start

15 Mar 2023

Estimated completion

31 Dec 2026

Solid Tumor, Adult Relapsed Cancer Refractory Cancer

What is this study about?

This study is investigating a new oral medication, HST-1011, for adults diagnosed with certain types of advanced solid tumours. These are cancers that have either spread throughout the body (metastatic), returned after treatment (recurrent), or cannot be surgically removed (unresectable). The focus is on patients whose cancer has not responded to previous standard treatments, such as certain immunotherapies (like anti-PD1/PD-L1 drugs) or other established care methods, or whose cancer has returned after these treatments.

The research is split into two main parts. The first part, called Phase 1, is about finding the safest and most effective dose of HST-1011. Some patients will receive HST-1011 on its own, gradually increasing the dose to see what is best. Other patients in this phase will receive HST-1011 combined with an existing approved cancer medicine called cemiplimab, which is a type of immunotherapy. The aim here is also to find the best dose for the combination treatment. The second part, Phase 2, will then use these determined doses to see how well HST-1011, especially in combination, works against the cancer.

Ultimately, this study aims to understand if HST-1011 can be a new and effective treatment option for patients with these challenging cancers. By carefully testing the new medicine, researchers hope to improve treatment outcomes for people who currently have limited options.

Key takeaways

This study is for adults with advanced solid cancers that haven't responded to previous treatments.
It tests a new medicine, HST-1011, sometimes with an existing immunotherapy called cemiplimab.
The study aims to find the best dose and see if the new medicine works against cancer.
You will have regular check-ups, blood tests, and scans.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be at least 18 years old and able to understand what's involved and agree to take part. You must have a confirmed advanced solid cancer that has either spread, returned, or cannot be removed by surgery. Specifically, your cancer should either have not responded to or have come back after treatments like anti-PD1/PD-L1 therapies, or you might have specific types of cancer such as platinum-resistant ovarian cancer, anal cancer, rectal cancer, or advanced prostate cancer that is no longer responding to hormone treatment. It's important that you have already tried standard treatments for your advanced cancer and they haven't worked.

There are also some reasons why you might not be able to join. For example, if you have an active autoimmune disease or need to take strong steroid medicines regularly. If you have had a bad reaction to anti-PD1/PD-L1 medicines, you might not be able to join the part of the study that uses cemiplimab. People who have participated in a study for a similar type of medicine (a CBL-B inhibitor) before, or who have untreated brain tumours causing symptoms, would also not be able to join. You shouldn't have any ongoing infections, including suspected COVID-19, or significant stomach problems that might stop you from absorbing oral medication.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have an advanced solid cancer that has returned or not responded to previous treatments?
Have you already tried standard treatments for your cancer?
Are you generally well and able to perform most daily activities?
Do you NOT have an active autoimmune disease or need strong steroid medications?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given the study medication, HST-1011, which you'll take regularly. Depending on which part of the study you're in, you might also receive cemiplimab, an approved cancer medicine, given by infusion. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. Before the treatment starts and at certain points during the study, you'll need to agree to have tissue samples taken (biopsies). The total length of your participation will depend on how you respond to the treatment and the phase of the study, though the follow-up period will continue even after treatment stops to track your progress. The team will explain the full schedule of visits and procedures if you are considering joining.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new medicine, HST-1011, helps to control your cancer when other treatments haven't worked. However, because this is an early-stage study, the full benefits are not yet known. Like all medicines, HST-1011 and cemiplimab can cause side effects. These can range from mild to serious, and the study team will monitor you closely for any issues. You will be fully informed of all known potential risks before you decide to join. It's very important to remember that participating in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (14)

Florida Cancer Specialists
Verified postcode
Sarasota, United States
Comprehensive Cancer Centers of Nevada
Verified postcode
Las Vegas, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
Montefiore Einstein Comprehensive Cancer Center
Verified postcode
The Bronx, United States
Providence Cancer Institute of Oregon
Verified postcode
Portland, United States
Abramson Cancer Center
Verified postcode
Philadelphia, United States
University of Pittsburgh (UPMC), Hillman Cancer Center
Verified postcode
Pittsburgh, United States
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States
University of Ottawa
Verified postcode
Ottawa, Canada
Princess Margaret Cancer Center
Verified postcode
Toronto, Canada
NEXT Oncology Barcelona IOB Hospital Quirónsalud
Verified postcode
Barcelona, Spain
Clínica Universidad de Navarra
Verified postcode
Madrid, Spain

Common questions

What is a 'solid tumour'?

A solid tumour is a lump or mass of abnormal tissue. It's different from blood cancers like leukaemia.

What does 'relapsed' or 'refractory' mean in cancer treatment?

'Relapsed' means your cancer has come back after treatment. 'Refractory' means your cancer hasn't responded to treatment as hoped.

What is HST-1011?

HST-1011 is a new medicine being tested. It's designed to work in a specific way within your immune system to fight cancer.

What is cemiplimab?

Cemiplimab is an approved cancer medicine already used for some cancers. It's a type of immunotherapy that helps your body's immune system fight cancer.

Will I definitely get the new medicine?

Yes, everyone in this study will receive HST-1011. Some will get it alone, and others will get it with cemiplimab.