Informations générales (source: ClinicalTrials.gov)
Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas
Interventional
Phase 1/Phase 2
GlaxoSmithKline (Voir sur ClinicalTrials)
juin 2026
novembre 2029
23 juillet 2026
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin VERRET | 23/07/2026 10:20:05 | Contacter | ||
Critères
Tous
- 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.