Study on the Effectiveness and Safety of Risvutatug Rezetecan for Advanced Sarcomas
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT07602777
This clinical trial is testing a new medication called Risvutatug Rezetecan (Ris-Rez) to see if it can help treat certain advanced cancers, specifically bone cancer (osteosarcoma) and soft tissue cancer (soft tissue sarcoma), in adolescents and adults. The study aims to determine if the drug is safe, how well patients tolerate it, and how the body processes it.
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Program Overview
The purpose of this study is to evaluate a new drug, Risvutatug Rezetecan (Ris-Rez), for its potential to treat advanced cancers such as osteosarcoma (a type of bone cancer) and soft tissue sarcoma (cancer starting in soft tissues like muscles or nerves). The study focuses on patients whose cancer has returned or spread after previous treatments and cannot be surgically removed. Researchers will assess the drug's safety, how well patients tolerate it, and how the body absorbs and breaks it down.
Eligibility Criteria
Inclusion Criteria
- Must be 12 years or older.
- Have a confirmed diagnosis of advanced or metastatic osteosarcoma or soft tissue sarcoma that cannot be surgically removed and has worsened after at least one previous treatment.
- Show disease progression on the last treatment as confirmed by imaging tests.
- Have a performance status indicating they are fully active or have some restrictions but can carry out light work.
- Have adequate organ function.
- Must provide signed informed consent and agree to follow the study protocol.
Exclusion Criteria
- Have previously received treatment with a specific type of drug called Antibody-drug-conjugates (ADC) with a TOPO1-inhibitor.
- Have known allergies to the study drug or its components.
- Have severe or uncontrolled heart problems.
- Have active infections requiring treatment or known HIV.
- Have untreated or worsening brain metastases or cancer spread to the brain or spinal cord.
- Have received another investigational treatment within 4 weeks before starting the study.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 84119-3602 | West Valley City | Utah |
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