Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors

This research is a two-part study looking at a new medicine called ST101 for adults with common advanced cancers, including glioma, melanoma, prostate cancer, and breast cancer. The first part focuses on finding a safe dose and understanding how the drug works in the body. The second part will test this safe dose in specific types of cancer to see if it helps shrink tumors. Patients in this study will have cancer that has either spread or has not responded well to standard treatments. ST101 will be given as a drip into a vein. The study aims to gather important information about this potential new treatment, checking for side effects and how effective it might be.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Sapience Therapeutics

Enrolment target

125

Start

01 Jul 2020

Estimated completion

01 Dec 2026

Glioblastoma Melanoma Stage IV Breast Cancer Prostate Cancer Glioblastoma Multiforme GBM Brain Cancer Metastatic Breast Cancer Metastatic Melanoma Metastatic Prostate Cancer Melanoma Recurrent Prostate Cancer Metastatic Recurrent Glioblastoma Newly Diagnosed Glioblastoma

What is this study about?

This study is a clinical trial exploring a new drug called ST101 for people living with advanced cancer. Advanced cancer means the cancer has spread or is difficult to treat with standard methods. The study is particularly interested in cancers like glioblastoma (a type of brain cancer), melanoma (a type of skin cancer), and breast and prostate cancer. The main goal is to find out if ST101 is safe, how well people tolerate it, and what dose works best. Researchers also want to see if the drug can help shrink tumors or stop them from growing.

The study has two main parts. The first part involves a small number of patients and focuses on carefully increasing the dose of ST101 to find the safest and most effective amount. This is called the 'dose-finding' phase. Patients in this part could have various advanced solid tumors that haven't responded to other available treatments. ST101 is given directly into a vein through a drip, usually once a week. Doctors will closely watch for any side effects.

Once a safe dose is found, the study moves to the second part, called the 'expansion phase'. Here, more patients with specific types of advanced cancer (like hormone-positive breast cancer, melanoma, glioblastoma, or castration-resistant prostate cancer) will receive ST101 at the chosen dose. This phase helps researchers get a better idea of how well the drug works against these particular cancers. They will regularly check the size of the tumors to see if they are getting smaller or staying stable. This important research helps us understand if ST101 could become a new treatment option in the future.

Key takeaways

This study is testing a new drug, ST101, for advanced cancers.
It aims to find a safe dose and see if the drug helps shrink tumors.
It's for adults whose cancer has not responded to other treatments.
ST101 is given as a drip into a vein, often once a week.
You will have regular check-ups, blood tests, and scans.
You might need a new tumor biopsy during the study.

Who may be eligible?

To join this study, you must be at least 18 years old. Your doctor will need to confirm that you have an advanced cancer that either hasn't responded to other treatments or you can't have certain standard treatments. This includes specific types of melanoma, breast cancer, prostate cancer, and glioblastoma.

During the first part of the study, you might be eligible if you have advanced melanoma, other carcinomas, or sarcomas. For the second part, the study is very specific about the cancer types. For example, if you have advanced hormone-positive breast cancer, it must have progressed after specific hormone treatments. If you have melanoma, it must have progressed after certain immune therapies.

You'll also need to be well enough to take part and able to come for appointments. In most cases, you would need to agree to provide a new small tissue sample (biopsy) of your tumor, both before and during the study. This helps researchers understand how the drug works. If your doctor thinks you meet these general requirements, they can look at the full list of criteria to see if this study is right for you.

Quick self-check

Are you 18 years old or older?
Do you have advanced cancer (like melanoma, glioblastoma, breast, or prostate cancer) that hasn't responded to other treatments?
Are you well enough to attend regular hospital appointments?
Would you be willing to have one or two new tumor biopsies if needed?
Are you able to provide consent for participating in the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, ST101 will be given to you through a drip into a vein (intravenously). Initially, this will be once a week. Doctors will closely monitor you, especially in the first week after your dose, to check for any side effects.

Throughout the study, you will have regular visits to the clinic for medical check-ups, blood tests, and scans to see how your cancer is responding. These scans might happen every few weeks. You may also need to provide a new tumor biopsy during the study. The total length of your participation will depend on how you respond to the treatment and the study's design. The clinical team will explain your specific schedule and the estimated duration during the consent process.

Potential risks and benefits

Taking part in this study means you could potentially benefit from a new drug that might help your cancer, especially if other treatments haven't worked. However, ST101 is an experimental drug, so its full benefits and side effects aren't yet completely known. Like all medicines, it might cause side effects, which will be carefully monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

University of California, San Francisco
San Francisco, United States
Sarah Cannon Research Institute
Denver, United States
Northwestern Medicine Cancer Centers
Warrenville, United States
START Midwest
Grand Rapids, United States
Columbia University
New York, United States
Duke University School of Medicine
Durham, United States
Sarah Cannon Research Institute
Nashville, United States
Edinburgh Cancer Centre
Edinburgh, United Kingdom
The Beaston West of Scotland Cancer Centre
Glasgow, United Kingdom
University of Leeds
Leeds, United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom

Common questions

What is ST101?

ST101 is a new, experimental drug being tested in this study to see if it can help treat advanced cancers. It's given through a drip into a vein.

What types of cancer is this study for?

This study is for people with advanced melanoma, glioblastoma (a type of brain cancer), breast cancer, and prostate cancer that hasn't responded to other treatments, among other solid tumors.

Will I get the new drug or a placebo?

Everyone in this study will receive the active drug, ST101. There is no placebo (dummy drug) in this trial.

How long will I be in the study?

The length of your participation can vary. You will continue to receive treatment as long as it is helping you and you are tolerating it well, or until the study's specific end points are reached. The study team will discuss this in detail.

Will I have to have a biopsy?

Yes, most participants will need to have a new biopsy (a small tissue sample taken from your tumor) both before starting treatment and again during the study. This helps researchers learn more about how the drug works.