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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
A Phase III, Open-Label, Multi Center, Randomized Study of LM-302 Versus Treatment of Physician's Choice (TPC) in Patients With CLDN18.2-Positive, Locally Advanced or Metastatic Gastric(GC) and Gastroesophageal Junction(GEJ) Adenocarcinoma.
This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy
A Phase II, Open-Label, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of LM-302 Combined With Toripalimab in CLDN18.2 Positive Patients Advanced Gastro-Intestinal Cancer
A Phase II, Open-Label, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of LM-302 Combined With Toripalimab in CLDN18.2 Positive Patients advanced gastro-Intestinal Cancer
一项评价 LM-302 联合特瑞普利单抗在 CLDN18.2 阳性的晚期消化道肿瘤受试者中的有效性、 安全性和耐受性的开放、多中心的Ⅱ期临床研究
[Translation] An open-label, multicenter phase II clinical study to evaluate the efficacy, safety, and tolerability of LM-302 combined with toripalimab in subjects with CLDN18.2-positive advanced gastrointestinal tumors
主要目的: 评估 LM-302 和特瑞普利单抗联合方案在 CLDN18.2 阳性的消化道肿瘤受
试者中的有效性。
次要目的:
评价 LM-302 和特瑞普利单抗联合方案的安全性;
评价 LM-302 的药代动力学(PK)特征;
评价 LM-302 的免疫原性;
评价 CLDN18.2 和 PD-L1 表达水平与 LM-302 和特瑞普利单抗联合方案抗
肿瘤活性的相关性。
[Translation] Primary objective: To evaluate the efficacy of the combination of LM-302 and Teplizumab in subjects with CLDN18.2-positive gastrointestinal tumors.
Secondary objectives:
To evaluate the safety of the combination of LM-302 and Teplizumab;
To evaluate the pharmacokinetic (PK) characteristics of LM-302;
To evaluate the immunogenicity of LM-302;
To evaluate the correlation between CLDN18.2 and PD-L1 expression levels and the anti-tumor activity of the combination of LM-302 and Teplizumab.
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