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Taking people in United KingdomPhase 1/2

Risvutatug Rezetecan for Advanced Sarcoma That Was Treated Before

Tests risvutatug rezetecan in adolescents and adults with previously treated advanced sarcoma.

Key facts

Who runs it
GlaxoSmithKline
Where
London and Manchester, United KingdomSee the 2 sitesAlso in 5 other countries, 11 sites
Registry title
A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)
Status
Recruiting
Phase
Phase 1/2
People taking part
64 people, planned
Started
22 Jun 2026
Expected to end
23 Nov 2029
Type of study
Interventional, 3 groups
Treatments tested
  • Ris-Rez
  • G-CSF
Record updated
1 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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 or older with osteosarcoma (a bone cancer) or soft tissue sarcoma that cannot be removed by surgery and has spread or come back after earlier treatment.

Age
12 years or older.
Sex
All sexes can join.
Disease stage
Osteosarcoma or soft tissue sarcoma that cannot be removed by surgery, is advanced or has spread, and has grown despite at least one earlier line of drug treatment. Growth on the last treatment must be confirmed by imaging.
Earlier treatment
Must have had at least one earlier line of systemic (whole-body) drug treatment. Must not have had an antibody-drug conjugate (ADC) with a TOPO1-inhibitor payload.

Main reasons for not taking part

  • Known HIV, or an active infection that needs treatment through the whole body
  • Severe, uncontrolled or active heart or blood vessel disease
  • Brain metastases with symptoms, or cancer in the membranes around the brain or spinal cord
  • Treatment with an investigational drug within 4 weeks before the first dose
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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)
  • Participants are excluded from the study if any of the following key exclusion criteria apply:
  • Is pregnant or breastfeeding

Where in United Kingdom

Also in 5 other countries, 11 sites

  • LondonHospital not named in the registryContact: Sandra Strauss (principal investigator)Taking people
  • ManchesterHospital not named in the registryContact: Alexander Lee (principal investigator)Taking people

About the trial

What the trial wants to find out

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

The 3 groups in the trial

  • Cohort 1A (Ris-Rez)Treatment being tested

    Treatment: Ris-Rez

  • Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]Treatment being tested

    Treatment: Ris-Rez and G-CSF

  • Cohort 2 (Ris-Rez)Treatment being tested

    Treatment: Ris-Rez

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas
Plain-language title
Risvutatug Rezetecan for Advanced Sarcoma That Was Treated BeforeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 October 2026