EMBOLD

A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Advanced Sarcomas (EMBOLD Sarcoma-202)

Agent: Risvutatug rezetecan (Ris-Rez);
G-CSF in one study group
Phase Ib/II
Status Recruiting
Sponsor GlaxoSmithKline (GSK)

 

For further information please also consult https://clinicaltrials.gov/study/NCT07602777.

EMBOLD Sarcoma-202 is a Phase 1b/2 study of risvutatug rezetecan (Ris-Rez) in adolescents and adults with advanced osteosarcoma or soft tissue sarcoma that has worsened after previous treatment and cannot be removed by surgery, or has spread to other parts of the body.

Ris-Rez is a B7-H3-targeted antibody drug conjugate (ADC). It is composed of an anti-B7-H3 monoclonal antibody, linked to a topoisomerase inhibitor payload. The antibody attaches to cancer cells carrying a marker called B7-H3. It delivers a cancer-killing drug directly to the cancer cells.

Researchers want to find out whether it can shrink or control these cancers, what side effects it causes, and how the body processes it. Some participants with osteosarcoma will also receive G-CSF, a medicine that helps the body produce white blood cells.

 

WHO is the trial for?
  • Adolescents and adults aged 12 years or older.
  • Confirmed osteosarcoma (bone cancer) that has returned or progressed, or advanced soft tissue sarcoma. The cancer cannot be removed by surgery or has spread.
  • Cancer has worsened after at least one previous systemic treatment, with progression shown on scans.
  • Good overall health status (ECOG 0–1, or equivalent score for adolescents).

Other medical criteria apply. The study team will determine eligibility.

WHAT is the key question that this trial is attempting to answer?

 Can Ris-Rez help shrink or control advanced osteosarcoma or soft tissue sarcoma? How safe and tolerable is it, and how does the body handle the medicine? Researchers will assess tumor responses and, for osteosarcoma, how many participants remain without cancer progression at 18 weeks.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is currently being conducted in the US, Canada, France, Israel, Japan, and the United Kingdom.

Check the registry for individual locations and current availability.

Contact: GSK Clinical Trials Call Centre
EU: +44 (0) 20 8990 4466
US: +1 877 379 3718
Email: GSKClinicalSupportHD@gsk.com

STUDY DESIGN: What does the study look like?

 Phase 1b/2, open-label study: participants and researchers know which treatment is given; there is no placebo group. Around 64 participants are planned.

  • Cohort 1 (osteosarcoma): participants are randomly assigned to Ris-Rez alone or Ris-Rez together with G-CSF.
  • Cohort 2 (soft tissue sarcoma): participants receive Ris-Rez.

Researchers monitor side effects, tumor response and how long the cancer remains controlled.

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken