A Phase1 b/2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of GSK5764227 Alone and in Combination in Participants With Previously Treated Advanced Unresectable or Metastatic Gastrointestinal Solid Tumors

GlaxoSmithKline86 个研究点分布在 11 个国家目标入组 451 人开始时间: 2025年6月11日最近更新: 2026年8月3日

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: GlaxoSmithKline
入组人数: 451
试验地点: 86
主要终点: Confirmed Objective Response Rate (ORR)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will check how well a new medicine, Risvutatug rezetecan, (Ris-Rez, also known as GSK5764227) works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.

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

年龄范围: 18 Years 至 —（Adult, Older Adult）
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:
•Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place years of age at the time of signing the informed consent form (ICF).
•Has histologically confirmed unresectable, locally advanced or unresectable metastatic adenocarcinoma of the colon or rectum (histology defined by World Health Organization (WHO) classification).
•PDAC Cohort
•Has histologically or cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the pancreas (histology defined by WHO classification).
•All Cohorts
•Is willing to use adequate contraception.
•Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
•Has an ECOG performance status of 0 or
•Has adequate organ function.

排除标准

•Participants are excluded from the study if any of the following criteria apply:
•Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of disease.
•Has had any major surgery within 28 days prior to randomization or first dose of study intervention, depending on sub-cohort/cohort assignment
•Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
•Has severe, uncontrolled or active cardiovascular disorders.
•Has serious or poorly controlled hypertension.
•Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
•Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
•Has evidence of current ILD/non-infectious pneumonitis or a prior history of ILD/non-infectious pneumonitis requiring high-dose glucocorticoids Or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging.
•Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to Grade 1 or to the baseline status preceding prior therapy.
•Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload.
•Is pregnant or breastfeeding.