NCT07602777招募中1 期
Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 113
- 试验地点
- 6
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •- 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.
研究组 & 干预措施
Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]
Experimental
干预措施: Ris-Rez (Biological)
Cohort 2 (Ris-Rez)
Experimental
干预措施: Ris-Rez (Biological)
Cohort 1A (Ris-Rez)
Experimental
干预措施: Ris-Rez (Biological)
Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]
Experimental
干预措施: G-CSF (Biological)
研究者
研究点 (6)
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