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

Официальное название

Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas

Обзор

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

Вмешательства

• Биопрепарат Ris-Rez
  Ris-Rez will be administered
• Биопрепарат G-CSF
  G-CSF will be administered

Первичные конечные точки

• Cohort 1: Progression free survival rate at Week18 (PFS18) [Срок оценки: At Week 18]
• Cohort 1 & 2: Confirmed Objective Response Rate (ORR) [Срок оценки: Up to approximately 98 weeks]

Вторичные конечные точки (12)

• Cohort 1 & 2: Number of participants with Adverse events (AEs) and serious AEs (SAEs) by severity [Срок оценки: Up to approximately 179 weeks]
• Cohort 1 & 2: Number of participants with AEs/SAEs leading to dose modifications or study intervention discontinuation or death [Срок оценки: Up to approximately 179 weeks]
• Cohort 1 & 2: Number of participants with a change from baseline in vital signs [Срок оценки: Baseline (Day-1) and up to approximately 179 weeks]
• Cohort 1 & 2: Number of participants with a change from baseline in body weight [Срок оценки: Baseline (Day-1) and up to approximately 179 weeks]
• Cohort 1 & 2: Number of participants with a change from baseline in laboratory parameters (haematology and clinical chemistry) [Срок оценки: Baseline (Day-1) and up to approximately 179 weeks]
• Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)] [Срок оценки: Baseline (Day-1) and up to approximately 179 weeks]
• Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status [Срок оценки: Baseline (Day-1) and up to approximately 179 weeks]
• Cohort 2: PFS rate at Week 18 (PFS18) [Срок оценки: At Week 18]
• Cohort 1 & 2: Duration of response (DoR) [Срок оценки: Up to approximately 179 weeks]
• Cohort 1 & 2: PFS rate at Week 30 (PFS30) [Срок оценки: At Week 30]
• Cohort 1 & 2: PFS [Срок оценки: Up to approximately 179 weeks]
• Cohort 1 & 2: Unconfirmed ORR [Срок оценки: Up to approximately 179 weeks]

Критерии участия

Критерии включения

\- 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

Критерии исключения

\- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 3 центра

• GSK Investigational Site — Bordeaux
• GSK Investigational Site — Lyon
• GSK Investigational Site — Villejuif

Канада · 2 центра

• GSK Investigational Site — Toronto
• GSK Investigational Site — Montreal

Япония · 1 центр

• GSK Investigational Site — Hokkaido

Идентификаторы

NCT: NCT07602777 · 300640 · 2025-523997-18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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