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New hope for Hard-to-Treat sarcomas? early trial launches
NCT ID NCT07602777
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 113 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
6 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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GSK Investigational Site
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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GSK Investigational Site
RECRUITINGMontreal, Quebec, QC H3H 2R9, Canada
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GSK Investigational Site
RECRUITINGBordeaux, 33076, France
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GSK Investigational Site
RECRUITINGLyon, 69373, France
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GSK Investigational Site
RECRUITINGVillejuif, 94805, France
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GSK Investigational Site
RECRUITINGHokkaido, 003-0804, Japan
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Other studies related to the condition(s) this trial covers.
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- Can a coordinated care team reduce severe side effects in older cancer patients?
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- Can repeated MRI scans reveal how tumors respond to radiation?