64 Participants NeededMy employer runs this trial

Risvutatug Rezetecan for Sarcoma

Recruiting at 12 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new medicine called Risvutatug Rezetecan (Ris-Rez) to determine its effectiveness in treating certain types of cancer, specifically osteosarcoma (bone cancer) and soft tissue sarcoma (cancer in muscles, fat, or nerves). The study will assess the medicine's safety, tolerance, and how the body processes it. Participants will be divided into different groups; some will receive only Ris-Rez, while others will receive it combined with another drug to boost white blood cells. This trial targets individuals aged 12 and older with these cancers that have recurred or spread after previous treatment. As a Phase 1 and Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study tested the drug risvutatug rezetecan, also known as Ris-Rez, for safety and showed promising results. Most participants tolerated the treatment well. Although some side effects occurred, they were usually mild to moderate, with more serious side effects being less common.

The study emphasized the importance of closely monitoring patients to effectively manage any side effects. These findings suggest that Ris-Rez has a manageable safety profile, making it a potential option for treating certain cancers. However, discussing potential risks with a healthcare provider remains important for any treatment.12345

Why do researchers think this study treatment might be promising for sarcoma?

Risvutatug Rezetecan is unique because it targets sarcoma cells in a way that could enhance the immune system's response to the cancer. Most treatments for sarcoma, like traditional chemotherapy and radiation, focus on directly killing cancer cells, but often come with significant side effects. This study drug, especially in combination with Granulocyte-Colony Stimulating Factor (G-CSF), aims to boost the body's own immune defenses, potentially leading to more effective and less toxic outcomes. Researchers are excited because this approach could represent a shift from conventional treatments, offering a more targeted and personalized therapy for patients with sarcoma.

What evidence suggests that Risvutatug Rezetecan might be an effective treatment for sarcoma?

Research has shown that Risvutatug Rezetecan, or Ris-Rez, yields promising results in cancer treatment. One study found that lung cancer patients taking Ris-Rez lived longer, with an average survival of 18.5 months compared to 10.3 months for those on another treatment. Ris-Rez also extended the time patients lived without their cancer worsening. The drug may work by targeting specific proteins on cancer cells, which can inhibit their growth. Although these results come from various cancer types, they offer hope that Ris-Rez might also be effective for sarcomas. Participants in this trial will receive Ris-Rez, with some cohorts also receiving Granulocyte-Colony Stimulating Factor (G-CSF) to potentially enhance treatment effects.16789

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older with advanced or metastatic osteosarcoma or soft tissue sarcoma that has come back or spread after at least one previous treatment, can't be removed by surgery, and whose major organs are working well. Participants must be able to care for themselves and agree to the study rules.

Inclusion Criteria

I am fully active or have only minor limitations in daily activities.
I am at least 12 years old.
My advanced or metastatic cancer has gotten worse after at least one treatment.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Risvutatug Rezetecan (Ris-Rez) with or without Granulocyte-Colony Stimulating Factor (G-CSF) for advanced sarcomas

Up to approximately 98 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in vital signs, body weight, laboratory parameters, and cardiac function

Up to approximately 179 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Risvutatug Rezetecan

Trial Overview

The study is testing a new drug called Risvutatug Rezetecan (Ris-Rez) in combination with G-CSF. It aims to see how safe and effective Ris-Rez is for treating advanced bone or soft tissue cancers that have not responded to other treatments.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Cohort 2 (Ris-Rez)Experimental Treatment1 Intervention
Group II: Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]Experimental Treatment2 Interventions
Group III: Cohort 1A (Ris-Rez)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

B7-H3 promise builds in underserved cancers

(HKEX:03692) reported that risvutatug rezetecan (ris-rez) met the primary progression-free survival (PFS) endpoint in the Phase III ARTEMIS ...

GSK's Ris-Rez shows survival benefit in lung cancer trial

Patients receiving Ris-Rez lived a median of 18.5 months compared with 10.3 months for those receiving topotecan after a median follow-up of ...

GSK's Ris-Rez shows survival benefit in lung cancer trial ...

Patients receiving Ris-Rez lived a median of 18.5 months compared with 10.3 months for those receiving topotecan after a median follow-up of ...

Real-world outcomes of atezolizumab versus durvalumab ...

Background: Advent landmark trials, IMpower133 and CASPIAN, demonstrated improved median progression-free survival (PFS) and overall survival (OS) among ...

GSK licensed cancer therapy succeeds in late-stage trial ...

GSK (GSK) reports a Phase 3 trial win in bone cancer for Ris-Rez, an antitumor drug licensed from its Chinese partner Hansoh Pharma (HNSPF).

(PDF) Clinical applications of antibody-drug conjugates in ...

We critically assess efficacy outcomes, safety profiles, predictive biomarkers, and toxicity management strategies—particularly regarding ...

Antibody-Drug Conjugate Safety Profiles in NSCLC

Garon, MD, MS, reviews the safety profiles of sacituzumab govitecan and datopotamab deruxtecan in patients with non–small cell lung cancer.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics ...

The goal of this study is to assess the safety and tolerability of Mocertatug Rezetecan . The study will also see how the levels of Mo-Rez ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/42534809/

Efficacy and safety of antibody-drug conjugates in EGFR ...

Results: Nine studies encompassing 1,092 patients were included. The pooled ORR was 44.7% (95% CI 36.7%-52.9%; I² = 84.4%), with substantial ...