This is a Phase II clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.The study is divided into two parts. The main objective of part I is to assess the efficacy and safety of JSKN016 in selected subjects with advanced non-small cell lung cancer. The main objective of part II is to compare the efficacy of JSKN016 and docetaxel in subjects with advanced non-small cell lung cancer.

Start Date17 Jan 2025

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

CTR20241426

/ RecruitingPhase 1

评估JSKN016在中国晚期恶性实体瘤受试者中的安全性、耐受性、药代动力学/药效学以及抗肿瘤活性的I期临床研究

[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and anti-tumor activity of JSKN016 in Chinese subjects with advanced malignant solid tumors

主要研究目的: 评价JSKN016治疗晚期恶性实体瘤患者的安全性和耐受性；确定JSKN016的最大耐受剂量（MTD）和/或推荐II期剂量（RP2D）次要研究目的: 评价JSKN016的抗肿瘤活性；评价JSKN016的药代动力学（PK）特征；评价JSKN016的免疫原性（ADA）探索性研究目的: 探索肿瘤组织标本（存档或新鲜活检标本）生物标志物和临床疗效之间的相关性；

[Translation]

Main study objectives: Evaluate the safety and tolerability of JSKN016 in the treatment of patients with advanced malignant solid tumors; Determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of JSKN016 Secondary study objectives: Evaluate the anti-tumor activity of JSKN016; Evaluate the pharmacokinetic (PK) characteristics of JSKN016; Evaluate the immunogenicity (ADA) of JSKN016 Exploratory study objectives: Explore the correlation between biomarkers and clinical efficacy in tumor tissue specimens (archived or fresh biopsy specimens);

Start Date13 May 2024

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

NCT06592417

/ RecruitingPhase 1

To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors

This is a Phase I open, multi-center, first-in-human study evaluating JSKN016 in subjects with advanced metastatic solid tumors, divided into dose escalation and dose extension.

Start Date30 Apr 2024

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

100 Clinical Results associated with JSKN016

100 Translational Medicine associated with JSKN016

100 Patents (Medical) associated with JSKN016

100 Deals associated with JSKN016

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	20 Dec 2024
Advanced Malignant Solid Neoplasm	Phase 1	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	30 Apr 2024

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