A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ris-Rez, G-CSF.
- Who it may be relevant to
- Registry conditions: Sarcoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada, France, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas
Overview
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
Interventions
- Biological Ris-Rez
Ris-Rez will be administered - Biological G-CSF
G-CSF will be administered
Primary outcome measures
- Cohort 1: Progression free survival rate at Week18 (PFS18) [Time frame: At Week 18]
- Cohort 1 & 2: Confirmed Objective Response Rate (ORR) [Time frame: Up to approximately 98 weeks]
Secondary outcome measures (12)
- Cohort 1 & 2: Number of participants with Adverse events (AEs) and serious AEs (SAEs) by severity [Time frame: Up to approximately 179 weeks]
- Cohort 1 & 2: Number of participants with AEs/SAEs leading to dose modifications or study intervention discontinuation or death [Time frame: Up to approximately 179 weeks]
- Cohort 1 & 2: Number of participants with a change from baseline in vital signs [Time frame: Baseline (Day-1) and up to approximately 179 weeks]
- Cohort 1 & 2: Number of participants with a change from baseline in body weight [Time frame: Baseline (Day-1) and up to approximately 179 weeks]
- Cohort 1 & 2: Number of participants with a change from baseline in laboratory parameters (haematology and clinical chemistry) [Time frame: Baseline (Day-1) and up to approximately 179 weeks]
- Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)] [Time frame: Baseline (Day-1) and up to approximately 179 weeks]
- Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status [Time frame: Baseline (Day-1) and up to approximately 179 weeks]
- Cohort 2: PFS rate at Week 18 (PFS18) [Time frame: At Week 18]
- Cohort 1 & 2: Duration of response (DoR) [Time frame: Up to approximately 179 weeks]
- Cohort 1 & 2: PFS rate at Week 30 (PFS30) [Time frame: At Week 30]
- Cohort 1 & 2: PFS [Time frame: Up to approximately 179 weeks]
- Cohort 1 & 2: Unconfirmed ORR [Time frame: Up to approximately 179 weeks]
Eligibility criteria
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 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.
- Is pregnant or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 3 centers
- GSK Investigational Site — Bordeaux
- GSK Investigational Site — Lyon
- GSK Investigational Site — Villejuif
Canada · 2 centers
- GSK Investigational Site — Toronto
- GSK Investigational Site — Montreal
Japan · 1 center
- GSK Investigational Site — Hokkaido
Identifiers
NCT: NCT07602777 · 300640 · 2025-523997-18