A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced … (NCT07602777) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)
113 participantsStarted 2026-07-14
Plain-language summary
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
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- 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
Exclusion Criteria:
\- Participants are excluded from the study if any of the following key exclusion criteria apply:
* Has received any prior therapy with an Antibody-drug-conjugates (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 progressi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cohort 1: Progression free survival rate at Week18 (PFS18)