Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Confirmed ORR, defined as the proportion of participants who have achieved a confirmed CR or PR as assessed by investigator, according to RECIST 1.1
研究概览
简要总结
• To evaluate clinical efficacy of Ris-Rez in participants with unresectable Relapsed/refractory (R/R) Osteosarcoma (OSA) (Cohort 1) who have progressed after or are intolerant to at least one prior line of systemic therapy.
• To evaluate clinical efficacy of Ris-Rez in participants with unresectable advanced or metastatic Soft tissue sarcoma (STS) (Cohort 2) who have progressed after or are intolerant to at least one prior line of systemic therapy.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Has received any prior therapy with an Antibody-drugconjugates (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.
研究组 & 干预措施
null
干预措施: null (Drug)
结局指标
主要结局
Confirmed ORR, defined as the proportion of participants who have achieved a confirmed CR or PR as assessed by investigator, according to RECIST 1.1
Confirmed ORR, defined as the proportion of participants who have achieved a confirmed CR or PR as assessed by investigator, according to RECIST 1.1
Progression free survival rate at week18 (PFS18) assessed by the investigator as per RECIST 1.1.
Progression free survival rate at week18 (PFS18) assessed by the investigator as per RECIST 1.1.
次要结局
未报告次要终点
研究者
EU GSK Clinical Trials Call Center
Scientific
Glaxosmithkline Research & Development Limited