Recruiting
Phase 1
Phase 2

Risvutatug Rezetecan

Sponsor:

GlaxoSmithKline

Code:

NCT07602777

Conditions

Sarcoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ris-Rez

G-CSF

Study Details

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

Study ID

NCT07602777

Start date

Jun 22, 2026

Status verified date

Sep, 2026

Completion date

Nov 23, 2029

Anticipated

Primary completion date

Nov 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1A (Ris-Rez)

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

experimental: Cohort 2 (Ris-Rez)

Interventions

Ris-Rez

Ris-Rez will be administered

G-CSF

G-CSF will be administered

Primary outcome measure

  • Cohort 1: Progression free survival rate at Week18 (PFS18) [ Time Frame: At Week 18 ]
  • Cohort 1 & 2: Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 98 weeks ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

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

Locations

GSK Investigational Site

Recruiting

West Valley City, Utah, United States, 84119-3602

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jose Pacheco

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Albiruni Abdul Razak

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ramy Saleh

More Information

Sponsor

GlaxoSmithKline

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.