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Hst-1011

Clinical trials are investigating Hst-1011 in people with advanced solid tumors that are not benefiting from standard treatments. The studies are looking at safety, tolerability, dose finding, and early signs of benefit in patients with select tumor types. One trial also studies Hst-1011 with cemiplimab.

Table of contents

Trial overview

The available study of Hst-1011 is a completed interventional trial, which means the researchers actively gave treatment and watched what happened.[1] It studied people with advanced solid tumors that were not benefiting from other standard of care therapies.[1] The trial enrolled 70 people and was run as a Phase 1/2 study.[1]

Who can participate

The trial focused on people with advanced cancers, especially advanced solid tumors.[1] The brief summary also says the study included patients with select tumor types, which means not every cancer type was included in every part of the study.[1] The study was designed for people who were not benefiting from other standard care therapies.[1]

There were two main study settings.[1] One part studied Hst-1011 as monotherapy, meaning it was given by itself.[1] Another part studied Hst-1011 in combination with cemiplimab, which means two drugs were used together.[1]

What is being measured

The main goals were to check safety and tolerability, which means how well people could take the treatment and what side effects happened.[1] The study measured dose-limiting toxicities, treatment-emergent adverse events, and serious adverse events.[1]

Researchers also tracked changes in laboratory tests, electrocardiograms (ECGs), vital signs, and physical exams.[1] These checks help show whether the treatment affects the body in ways that matter for safety.[1]

Other endpoints included pharmacokinetics (how the body handles the drug), pharmacodynamics (how the drug affects the body), and preliminary efficacy, which means early signs of whether the treatment may help the cancer.[1]

Study design and treatment groups

The study had two main parts described in the brief summary.[1] In the first part, researchers looked at the initial safety and tolerability of Hst-1011 alone and tried to find the recommended Phase 2 dose and schedule.[1] In the second part, they studied Hst-1011 together with cemiplimab and again looked for the recommended Phase 2 dose and schedule.[1]

The trial also included different oral doses of Hst-1011: 5 mg, 10 mg, 40 mg, and 150 mg.[1] The study also listed LIBTAYO 350 mg as an intravenous infusion in the intervention section.[1]

What the Phase 1/2 label means

A Phase 1/2 study usually has two steps.[1] The first step focuses on safety, side effects, and dose finding.[1] The second step starts to look more closely at whether the treatment may work against the cancer.[1]

For Hst-1011, this means the researchers were not only checking whether the treatment could be given safely, but also whether they could choose a dose and schedule for later studies.[1] They also wanted early signs of benefit in patients with select tumor types.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05662397 Phase 1/2 Advanced solid tumors Completed 70

FAQ

  • What is being studied in Hst-1011 trials? The trials are studying Hst-1011 in people with advanced cancers, especially advanced solid tumors. Researchers are checking safety, tolerability, dose, and early signs of benefit.
  • Who may join these trials? The main study includes people with advanced cancers that are not helping from other standard care therapies. Some parts focus on select tumor types, so eligibility depends on the cancer type and study part.
  • What phase is the Hst-1011 trial? The main study is Phase 1/2. This means it first looks at safety and dose, then begins to look more closely at early effectiveness.
  • What conditions are being studied? The trial is studying advanced solid tumors. It also includes select tumor types in parts of the study.
  • What outcomes are the researchers measuring? They are measuring dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, lab changes, ECGs, vital signs, and physical exams. The study also looks at pharmacokinetics, pharmacodynamics, and preliminary efficacy.

Ongoing Clinical Trials on Hst-1011

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

    Not recruiting

    1 1 1
    Investigated drugs:
    Spain

Glossary

  • Advanced solid tumors: Cancers that have grown or spread and are not limited to one small area. In this study, the term refers to non-blood cancers.
  • Phase 1/2: A study stage that first checks safety and dose, then gathers early information about whether the treatment may help.
  • Monotherapy: Treatment with one study drug only, without another cancer drug added.
  • Combination therapy: Treatment that uses Hst-1011 together with another drug. In this trial, that other drug is cemiplimab.
  • Recommended Phase 2 Dose (RP2D): The dose and schedule chosen for later studies after early safety testing.
  • Dose-limiting toxicities (DLTs): Side effects that are serious enough to limit how much of a study drug can be given.
  • Treatment-emergent adverse events (TEAEs): Side effects or health problems that happen after treatment starts.
  • Serious adverse events (SAEs): Severe medical problems during the study that may require urgent care or hospital treatment.
  • Laboratory assessments: Blood or other test results used to check body function and safety during the study.
  • Electrocardiogram (ECG): A test that records the heart’s electrical activity.
  • Pharmacokinetics (PK): How the body absorbs, moves, and removes the study drug.
  • Pharmacodynamics (PDc): How the study drug affects the body.

References