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New hope for Hard-to-Treat sarcomas? early trial launches

NCT ID NCT07602777

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This study tests a new medicine called Risvutatug Rezetecan (Ris-Rez) in adolescents and adults with advanced bone or soft tissue sarcomas that have come back or spread and can't be removed by surgery. The goal is to see if the drug can slow cancer growth and how safe it is. About 113 participants will receive Ris-Rez along with a supportive drug (G-CSF) to help manage side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Risvutatug Rezetecan (Ris-Rez), a biologic drug given by infusion, plus G-CSF to support white blood cell counts
What this could lead to
If it works, this could offer a new treatment option for people with advanced sarcomas that have stopped responding to other therapies.
What could go wrong
This is an early-phase trial with only 113 participants, so results may not apply to everyone. The drug may cause side effects or fail to control the cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 113 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Participants are eligible to be included in the study only if all of the following criteria apply * Participants must be ≥ 12 years of age. * Has histologically confirmed unresectable advanced or metastatic R/R OSA (Cohort 1) or unresectable advanced or metastatic STS (Cohort 2) that has progressed to at least one prior line of systemic therapy. * Has documented disease progression on the last line of systemic treatment as confirmed by radiological imaging * Has an ECOG performance status of 0 or 1, or Lansky PS/Karnofsky PS ≥ 70% for adolescent participants, with no deterioration in the 2 weeks prior to first dose/randomization. * Has adequate organ function. * All participants, or their legal guardians, must provide signed informed consent and agree to follow the study protocol before starting any study activities Exclusion Criteria: \- Participants are excluded from the study if any of the following key exclusion criteria apply: * Has received any prior therapy with an Antibody-drug-conjugates (ADC) with a TOPO1-inhibitor payload. * Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study. * Has severe, uncontrolled or active cardiovascular disorders. * Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV). * Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases. * Has received treatment with an investigational agent within 4 weeks of the first dose of study intervention. * Is pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, QC H3H 2R9, Canada

  • GSK Investigational Site

    RECRUITING

    Bordeaux, 33076, France

  • GSK Investigational Site

    RECRUITING

    Lyon, 69373, France

  • GSK Investigational Site

    RECRUITING

    Villejuif, 94805, France

  • GSK Investigational Site

    RECRUITING

    Hokkaido, 003-0804, Japan

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