2025-523997-18-00RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)
Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Jul 2026
Brief summary (registry, in English)
• To evaluate clinical efficacy of Ris-Rez in participants with unresectable Relapsed/refractory (R/R) Osteosarcoma (OSA) (Cohort 1) who have progressed after or are intolerant to at least one prior line of systemic therapy. • To evaluate clinical efficacy of Ris-Rez in participants with unresectable advanced or metastatic Soft tissue sarcoma (STS) (Cohort 2) who have progressed after or are intolerant to at least one prior line of systemic therapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- 29 Jun 2026
- Lead sponsor
- Glaxosmithkline Research & Development Limited
- Diseases
- Childhood cancers, Sarcoma
- EU CT number
- 2025-523997-18-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 14
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 to 64 with sarcoma that cannot be removed by surgery and has spread or come back. Cohort 1 is for osteosarcoma and Cohort 2 for soft tissue sarcoma.
- Age
- 12 to 64 years
- Sex
- All sexes
- Disease stage
- Osteosarcoma that came back or did not respond to treatment (Cohort 1), or soft tissue sarcoma (Cohort 2). Either must be advanced or spread, cannot be removed by surgery, and be confirmed under the microscope.
- Earlier treatment
- Must have had at least one earlier line of systemic treatment, and the disease must have grown during or after the last one. Cannot have had an antibody-drug conjugate (ADC) with a TOPO1-inhibitor payload.
Main reasons for not taking part
- Earlier treatment with an ADC with a TOPO1-inhibitor payload
- Severe, uncontrolled or active heart or blood vessel disease
- Active infection needing systemic treatment, or known HIV
- Brain metastases with symptoms, or spread to the brain or spinal cord linings or spinal cord
- Pregnant or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received any prior therapy with an Antibody-drugconjugates (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."
- 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.
Other illness
- Has severe, uncontrolled or active cardiovascular disorders.
Other
- Is pregnant or breastfeeding.
Who the study is looking for
- 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
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Bergonie | Bordeaux | France | Recruiting |
| Centre Leon Berard | Lyon | France | Recruiting |
| Institut Gustave Roussy | Villejuif | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.