A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)
Key facts
- Where
- Bordeaux, Lyon és Villejuif, FranciaországSee the 3 sites
- Phase
- 1/2. fázis
Where in Franciaország
- Institut BergonieBordeaux, FranciaországTaking people
- Centre Leon BerardLyon, FranciaországTaking people
- Institut Gustave RoussyVillejuif, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Glaxosmithkline Research & Development Limited
- Trial code
- EU 2025-523997-18-00
- Record updated
- 2026. július 27.
- Original description
• 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.Read full original descriptionShow less
Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas
• 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.
Inclusion: 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: 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; Has severe, uncontrolled or active cardiovascular disorders; Is pregnant or breastfeeding.