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

NCT07602777 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 3006402025-523997-18
• Study Type: interventional
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Sarcoma

Keywords

EMBOLD Sarcoma-202; Risvutatug Rezetecan; Ris-Rez; Sarcoma

Outcome Measures

Primary Outcomes (2)

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

  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)

  At Week 18

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

  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

  Up to approximately 98 weeks

Secondary Outcomes (16)

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

  Up to approximately 179 weeks

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

  Up to approximately 179 weeks

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

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

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

  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)

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

Study Arms (3)

Cohort 1A (Ris-Rez)

EXPERIMENTAL

Biological: Ris-Rez

Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]

EXPERIMENTAL

Biological: Ris-Rez; Biological: G-CSF

Cohort 2 (Ris-Rez)

EXPERIMENTAL

Biological: Ris-Rez

Interventions

Ris-Rez BIOLOGICAL

Ris-Rez will be administered

Cohort 1A (Ris-Rez); Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]; Cohort 2 (Ris-Rez)

G-CSF BIOLOGICAL

G-CSF will be administered

Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Sarcoma

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): July 14, 2026
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): December 17, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.