BridgeMD
A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)
EU CTIS ID: 2025-523997-18-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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
You likely can't join if
- • 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."
- • 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.
See the full eligibility criteria
- • 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
- • 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."
- • 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Israel
- United Kingdom
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Israel; United Kingdom; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.