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Clinical Trials associated with GFS202A / Not yet recruitingPhase 1 一项评估GFS202A 在肿瘤恶病质前期及恶病质期患者中的安全性/耐受性、药代动力学的开放标签、多中心I期临床研究
[Translation] An open-label, multicenter Phase I clinical study evaluating the safety/tolerability and pharmacokinetics of GFS202A in patients with precachexia and cachexia
主要目的:评估GFS202A 在肿瘤恶病质前期及恶病质期患者中的安全性/耐受性;确定GFS202A 的最大耐受剂量(MTD)和/或为未来研究推荐的剂量范围
次要目的:评估GFS202A 在肿瘤恶病质前期及恶病质期患者中的药代动力学(PK)特征;评估GFS202A 在肿瘤恶病前期及恶病质期患者中的免疫原性;评估GFS202A 在肿瘤恶病质前期及恶病质期患者中的药效学生物标志物;评估GFS202A 对肿瘤恶病质前期及恶病质期患者体重的影响;评估GFS202A 对肿瘤恶病质前期及恶病质期患者体重的影响;评估GFS202A 对肿瘤恶病质前期及恶病质期患者的厌食/恶病质改善情况;评估GFS202A 对肿瘤恶病质前期及恶病质期患者的食欲改善情况。
探索性目的:评估GFS202A 在肿瘤恶病质前期及恶病质期患者中的其他生物标志物;评估GFS202A 对肿瘤恶病质前期及恶病质期患者身体成分的影响;评估GFS202A 对晚期肿瘤的影响
[Translation] Primary objectives: To evaluate the safety/tolerability of GFS202A in patients with pre-cachexia and cachexia; To determine the maximum tolerated dose (MTD) of GFS202A and/or the recommended dose range for future studies
Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of GFS202A in patients with pre-cachexia and cachexia; To evaluate the immunogenicity of GFS202A in patients with pre-cachexia and cachexia; To evaluate the pharmacodynamic biomarkers of GFS202A in patients with pre-cachexia and cachexia; To evaluate the effect of GFS202A on the body weight of patients with pre-cachexia and cachexia; To evaluate the effect of GFS202A on the body weight of patients with pre-cachexia and cachexia; To evaluate the improvement of anorexia/cachexia in patients with pre-cachexia and cachexia; To evaluate the improvement of appetite in patients with pre-cachexia and cachexia.
Exploratory objectives: To evaluate other biomarkers of GFS202A in patients with pre-cachexia and cachexia; To evaluate the effect of GFS202A on body composition in patients with pre-cachexia and cachexia; To evaluate the effect of GFS202A on advanced tumors
/ Not yet recruitingPhase 1 An Open-label, Multi-center, Phase I Study to Evaluate the Safety/tolerability and Pharmacokinetics of GFS202A in Advanced Solid Tumor Patients with Pre-cachexia or Cachexia
An open-label, multi-center, phase I study to evaluate the safety/tolerability and pharmacokinetics of GFS202A in advanced solid tumor patients with pre-cachexia or cachexia. The primary objective is to assess the safety/tolerability of GFS202A, determine its maximum tolerated dose (MTD), and recommend a dose range for future studies.
Enroll participants with cancer cachexia or precachexia to receive GFS202A monotherapy. During the study period, participants will undergo assessments for safety and preliminary efficacy according to the visit schedule. Pharmacokinetic, anti-drug antibody (ADA), and pharmacodynamic (PD) /biomarker samples will be collected.
100 Clinical Results associated with GFS202A
100 Translational Medicine associated with GFS202A
100 Patents (Medical) associated with GFS202A
100 Deals associated with GFS202A