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

13. juli 2026 oppdatert av: GlaxoSmithKline

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

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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

113

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Albiruni Ryan Ryan Abdul Abdul Razak
    • Quebec
      • Montreal, Quebec, Canada, QC H3H 2R9
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ramy Saleh
  • Frankrike
      • Bordeaux, Frankrike, 33076
        • Rekruttering
        • GSK Investigational Site
        • Hovedetterforsker:
          • Maud Toulmonde
        • Ta kontakt med:
        • Ta kontakt med:
      • Lyon, Frankrike, 69373
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Armelle Dufresne
      • Villejuif, Frankrike, 94805
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Benjamin Verret
  • Japan
      • Hokkaido, Japan, 003-0804
        • Rekruttering
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hiroaki Hiraga

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort 1A (Ris-Rez)
Biologisk: Ris-Rez
Ris-Rez vil bli administrert
Eksperimentell: Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]
Biologisk: Ris-Rez
Ris-Rez vil bli administrert
Biologisk: G-CSF
G-CSF will be administered
Eksperimentell: Cohort 2 (Ris-Rez)
Biologisk: Ris-Rez
Ris-Rez vil bli administrert

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cohort 1: Progression free survival rate at Week18 (PFS18)
Tidsramme: 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)
At Week 18
Cohort 1 & 2: Confirmed Objective Response Rate (ORR)
Tidsramme: 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
Up to approximately 98 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cohort 1 & 2: Number of participants with Adverse events (AEs) and serious AEs (SAEs) by severity
Tidsramme: Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Number of participants with AEs/SAEs leading to dose modifications or study intervention discontinuation or death
Tidsramme: Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in vital signs
Tidsramme: Baseline (Day-1) and up to approximately 179 weeks
Number of participants will be assessed
Baseline (Day-1) and up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in body weight
Tidsramme: Baseline (Day-1) and up to approximately 179 weeks
Number of participants will be assessed
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)
Tidsramme: Baseline (Day-1) and up to approximately 179 weeks
Number of participants will be assessed
Baseline (Day-1) and up to approximately 179 weeks
Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)]
Tidsramme: Baseline (Day-1) and up to approximately 179 weeks
Number of participants will be assessed
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
Tidsramme: Baseline (Day-1) and up to approximately 179 weeks
Number of participants will be assessed
Baseline (Day-1) and up to approximately 179 weeks
Cohort 2: PFS rate at Week 18 (PFS18)
Tidsramme: 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
At Week 18
Cohort 1 & 2: Duration of response (DoR)
Tidsramme: 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
Up to approximately 179 weeks
Cohort 1 & 2: PFS rate at Week 30 (PFS30)
Tidsramme: 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
At Week 30
Cohort 1 & 2: PFS
Tidsramme: 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
Up to approximately 179 weeks
Cohort 1 & 2: Unconfirmed ORR
Tidsramme: 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.
Up to approximately 179 weeks
Cohort 1 & 2: Observed pharmacokinetic (PK) concentration of Ris-Rez (conjugated antibody) and payload
Tidsramme: Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Proportion of participants with positive and total Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Tidsramme: Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Titers of ADA against Ris-Rez
Tidsramme: Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Participant-reported experience on study treatment
Tidsramme: Up to approximately 179 weeks
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
Up to approximately 179 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. juni 2026

Primær fullføring (Antatt)

18. november 2027

Studiet fullført (Antatt)

23. november 2029

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

19. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 300640
  • 2025-523997-18 (Annen identifikator: EU CT Number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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