Risvutatug Rezetecan in advanced sarcoma: a first-in-cohort study for adolescents and adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional, multi-cohort study combining Phase 1 and Phase 2 to evaluate Ris-Rez safety, tolerability, pharmacokinetics, and preliminary efficacy in adolescents and adults with unresectable, advanced or metastatic osteosarcoma or soft tissue sarcoma that progressed after prior therapy. Participants receive Ris-Rez with supportive G-CSF as needed, and are monitored for adverse events, response by imaging, and overall disease control. Eligibility requires measurable disease, adequate organ function, good performance status, and prior systemic therapy. The study aims to identify a recommended dose and gather initial signals of clinical activity to guide future development.

Why it matters

Who can join: the full rules

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.

Where it's running

• GSK Investigational Site
  West Valley City, Utah, United States Recruiting
• GSK Investigational Site
  Toronto, Ontario, Canada Recruiting
• GSK Investigational Site
  Montreal, Quebec, Canada Recruiting
• GSK Investigational Site
  Bordeaux, France Recruiting
• GSK Investigational Site
  Lyon, France Recruiting
• GSK Investigational Site
  Villejuif, France Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.