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Clinical Trials associated with GEN-725A Phase Ⅰ Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of GEN-725 Tablets in Patients With Advanced Solid Tumors
A phase Ⅰ clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of GEN-725 tablets in patients with advanced solid tumors.
/ Not yet recruitingPhase 1/2 评价GEN-725联合哆希替尼在EGFR突变的局部晚期或转移性非小细胞肺癌患者中的安全性和有效性的I/IIa期临床研究
[Translation] A phase I/IIa clinical study evaluating the safety and efficacy of GEN-725 combined with doxitinib in patients with locally advanced or metastatic non-small cell lung cancer and EGFR mutations
I期
主要目的:
评价GEN-725联合哆希替尼在既往至少经过一线治疗的EGFR突变的局部晚期或转移性NSCLC患者中的安全性及耐受性,确定RP2D。
次要目的:
评价GEN-725联合哆希替尼在既往至少经过一线治疗的EGFR突变的局部晚期或转移性NSCLC患者中的有效性;
评价GEN-725联合哆希替尼在既往至少经过一线治疗的EGFR突变的局部晚期或转移性NSCLC患者中的药代动力学特征。
探索性目的:
探索肿瘤微环境与疗效的相关性;
探索血浆游离循环肿瘤DNA(ctDNA)和/或肿瘤组织中基因突变与疗效的相关性(仅既往经三代EGFR-TKI治疗后进展的受试者)。
IIa期
主要目的:
评价GEN-725联合哆希替尼在EGFR突变的局部晚期或转移性NSCLC患者中的有效性;及其安全性。
次要目的:
评价GEN-725联合哆希替尼在EGFR突变的局部晚期或转移性NSCLC患者中的药代动力学特征。
探索性目的:
探索肿瘤微环境与疗效的相关性;
探索血浆游离ctDNA和/或肿瘤组织中基因突变与疗效的相关性(仅既往经三代EGFR-TKI治疗后进展的受试者)。
[Translation] Phase I
Primary Objectives:
To evaluate the safety and tolerability of GEN-725 combined with doxitinib in patients with locally advanced or metastatic NSCLC harboring EGFR mutations who have received at least one prior line of therapy, and to determine the RP2D.
Secondary Objectives:
To evaluate the efficacy of GEN-725 combined with doxitinib in patients with locally advanced or metastatic NSCLC harboring EGFR mutations who have received at least one prior line of therapy;
To evaluate the pharmacokinetic profile of GEN-725 combined with doxitinib in patients with locally advanced or metastatic NSCLC harboring EGFR mutations who have received at least one prior line of therapy.
Exploratory Objectives:
To investigate the association between tumor microenvironment and efficacy;
To investigate the association between gene mutations in plasma circulating tumor DNA (ctDNA) and/or tumor tissue and efficacy (only patients who have progressed after prior treatment with third-generation EGFR-TKIs).
Phase IIa
Primary Objectives:
To evaluate the efficacy and safety of GEN-725 combined with doxitinib in patients with locally advanced or metastatic NSCLC harboring EGFR mutations. Secondary objectives:
Evaluate the pharmacokinetic profile of GEN-725 combined with doxitinib in patients with locally advanced or metastatic NSCLC harboring EGFR mutations.
Exploratory objectives:
To investigate the association between the tumor microenvironment and efficacy;
To investigate the association between gene mutations in plasma cell-free ctDNA and/or tumor tissue and efficacy (limited to patients whose disease has progressed after prior treatment with third-generation EGFR-TKIs).
100 Clinical Results associated with GEN-725
100 Translational Medicine associated with GEN-725
100 Patents (Medical) associated with GEN-725
100 Deals associated with GEN-725