Last updated: 05/11/2026 17:40:08

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

GSK study ID
300640
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
2025-523997-18
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Cohort 1: Progression free survival rate at Week18 (PFS18)

Timeframe: At Week 18

Cohort 1 & 2: Confirmed Objective Response Rate (ORR)

Timeframe: Up to approximately 98 weeks

Secondary outcomes:

Cohort 1 & 2: Number of participants with Adverse events (AEs) and serious AEs (SAEs) by severity

Timeframe: Up to approximately 179 weeks

Cohort 1 & 2: Number of participants with AEs/SAEs leading to dose modifications or study intervention discontinuation or death

Timeframe: Up to approximately 179 weeks

Cohort 1 & 2: Number of participants with a change from baseline in vital signs

Timeframe: Baseline (Day-1) and up to approximately 179 weeks

Cohort 1 & 2: Number of participants with a change from baseline in body weight

Timeframe: 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)

Timeframe: Baseline (Day-1) and up to approximately 179 weeks

Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)]

Timeframe: 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

Timeframe: Baseline (Day-1) and up to approximately 179 weeks

Cohort 2: PFS rate at Week 18 (PFS18)

Timeframe: At Week 18

Cohort 1 & 2: Duration of response (DoR)

Timeframe: Up to approximately 179 weeks

Cohort 1 & 2: PFS rate at Week 30 (PFS30)

Timeframe: At Week 30

Cohort 1 & 2: PFS

Timeframe: Up to approximately 179 weeks

Cohort 1 & 2: Unconfirmed ORR

Timeframe: Up to approximately 179 weeks

Cohort 1 & 2: Observed pharmacokinetic (PK) concentration of Ris-Rez (conjugated antibody) and payload

Timeframe: At Cycle 1 and Cycle 3

Cohort 1 & 2: Proportion of participants with positive and total Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez

Timeframe: Up to approximately 179 weeks

Cohort 1 & 2: Titers of ADA against Ris-Rez

Timeframe: Up to approximately 179 weeks

Cohort 1 & 2: Participant-reported experience on study treatment

Timeframe: Up to approximately 179 weeks

Interventions:
Biological/vaccine: Ris-Rez
Biological/vaccine: G-CSF
Enrollment:
113
Observational study model:
Not applicable
Primary completion date:
2027-10-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sarcoma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2026 to December 2029
Type
Interventional
Phase
1/2

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
  • Participants are eligible to be included in the study only if all of the following criteria apply
  • Participants must be ≥ 12 years of age.
  • 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.
Inclusion and exclusion 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.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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