NCT07602777RecruitingPhase 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: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
The main goal of this study is to test a new medicine, Risvutatug Rezetecan also called Ris-Rez. We want to see if this medicine can help people with certain types of cancer, whether its safe to use, how well people tolerate it, and how their bodies handle the drug (how its absorbed and broken down). This research is for adolescents and adults who have either: Osteosarcoma, which is a type of bone cancer, or Soft Tissue Sarcoma, which is a type of cancer that starts in soft body tissues (like muscle, fat, or nerves). In both cancer types the cancer must have already been treated, but has come back or spread, and cant be removed by surgery
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 11 May 2026
- Start date
- 22 Jun 2026
- Primary completion date
- 5 Nov 2027
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT07602777
- EudraCT number
- 2025-523997-18
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 64
- From 22 Jun 2026 to the primary completion date, 5 Nov 2027
- 13 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received any prior therapy with an Antibody-drug-conjugates (ADC) with a TOPO1-inhibitor payload.
- 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 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).
Other
- \- Participants are excluded from the study if any of the following key exclusion criteria apply:
- Is pregnant or breastfeeding.
Who the study is looking for
- \- 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
Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| - Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| - Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Hokkaido | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| - Coordinator of this site? Confirm its status | West Valley City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.