Study of Risvutatug Rezetecan for Advanced or Metastatic Sarcomas in Adolescents and Adults

What this Trial Is About

Researchers are evaluating a new medicine called Risvutatug Rezetecan Ris-Rez for adolescents and adults with certain cancers, specifically osteosarcoma a type of bone cancer and soft tissue sarcoma cancer in soft tissues like muscle, fat, or nerves. These cancers must have been previously treated but have returned or spread and cannot be removed by surgery. The study aims to assess the safety, tolerability, and how the body processes this medicine. Participants will receive Ris-Rez in one of three groups receiving Ris-Rez alone, Ris-Rez combined with Granulocyte-Colony Stimulating Factor G-CSF, or Ris-Rez alone in a separate cohort. The study is randomized and involves monitoring how well participants tolerate the medicine and how it affects their cancer. Dosage, administration details, and schedules are managed per the study protocol over an extended period. During the study, participants will undergo various assessments including monitoring of disease progression, adverse events, vital signs, body weight, laboratory tests such as blood counts and chemistry, heart function via electrocardiogram, and performance status. Researchers will also measure responses to treatment and collect data on drug levels and immune reactions. Participant experiences with the study treatment are recorded. The study includes long-term follow-up for safety and effectiveness over several weeks, with some outcome measures tracked up to approximately 179 weeks.

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