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

Sponsor
GlaxoSmithKline
Study ID
NCT07602777
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ris-Rez — BIOLOGICAL
    Ris-Rez will be administered
  • G-CSF — BIOLOGICAL
    G-CSF will be administered

Study Details

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

Key Dates

First listed
May 22, 2026
Start date
Jun 22, 2026
Status verified
Jul 2026
Primary completion
Nov 18, 2027
Completion
Nov 23, 2029

Study Design

Enrollment
113 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Cohort 1: Progression free survival rate at Week18 (PFS18) [ Time Frame: At Week 18 ]

Central Contacts

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