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NCT Number: NCT07602777

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

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

Recruiting

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GSK Investigational Site, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ris-Rez

Biological

Ris-Rez will be administered

G-CSF

Biological

G-CSF will be administered

Primary outcomes

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

    Time frame: At Week 18

    PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

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

    Time frame: Up to approximately 98 weeks

    Confirmed ORR is defined as the proportion of participants who have achieved a confirmed Complete Response (CR) or Partial Response PR as assessed by investigator, according to RECIST 1.1

Secondary outcomes

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

    Time frame: Up to approximately 179 weeks

  2. 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

  3. 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

    Number of participants will be assessed

  4. 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

    Number of participants will be assessed

  5. 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 will be assessed

  6. 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 will be assessed

  7. 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

    Number of participants will be assessed

  8. Cohort 2: PFS rate at Week 18 (PFS18)

    Time frame: At Week 18

    PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to RECIST 1.1

  9. Cohort 1 & 2: Duration of response (DoR)

    Time frame: Up to approximately 179 weeks

    DoR is defined as the time from the date of the first documented objective response (CR/PR) that is subsequently confirmed, until the date of the first documented PD or death, whichever is earlier, as assessed by investigator according to RECIST 1.1

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

    Time frame: At Week 30

    PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to RECIST 1.1

  11. Cohort 1 & 2: PFS

    Time frame: Up to approximately 179 weeks

    PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to RECIST 1.1

  12. Cohort 1 & 2: Unconfirmed ORR

    Time frame: Up to approximately 179 weeks

    Unconfirmed ORR is defined as the proportion of participants who have achieved a response of CR or PR (without confirmation) as assessed by the investigator according to RECIST 1.1.

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

    Time frame: Up to approximately 179 weeks

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

    Time frame: Up to approximately 179 weeks

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

    Time frame: Up to approximately 179 weeks

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

    Time frame: Up to approximately 179 weeks

    Number of participants who reported their experience with study treatment using validated questionnaires will be measured

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
May 22, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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