Delving into the Latest Updates on SKB-518 with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Target

PTK7

Mechanism

PTK7 modulators(Protein-tyrosine kinase 7 modulators)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Sichuan Kelun Botai Biomedicine Co., Ltd.

Active Organization

Sichuan Kelun Botai Biomedicine Co., Ltd.

Sichuan Kelun Pharmacy Institute Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure

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This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available.

Start Date30 Jun 2024

Sponsor / Collaborator

Sichuan Kelun Pharmacy Institute Co., Ltd.

CTR20242227 / RecruitingPhase 1

注射用SKB518治疗晚期实体瘤受试者的安全性、耐受性、药代动力学和抗肿瘤活性的I期临床研究

[Translation] Phase I clinical study of the safety, tolerability, pharmacokinetics and anti-tumor activity of SKB518 for injection in subjects with advanced solid tumors

主要目的 1、评估SKB518单药治疗晚期实体瘤受试者的安全性和耐受性、剂量限制毒性（DLT），确定最大耐受剂量（MTD）和/或最大给药剂量（MAD）。 2、次要目的评估SKB518在晚期实体瘤受试者中的药代动力学（PK）特征；评估SKB518在晚期实体瘤受试者中的免疫原性；基于实体瘤疗效评价标准（RECIST）v1.1，评估SKB518在晚期实体瘤受试者中的抗肿瘤活性。

[Translation]

Main objectives 1. Evaluate the safety and tolerability of SKB518 monotherapy in subjects with advanced solid tumors, dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD). 2. Secondary objectives Evaluate the pharmacokinetic (PK) characteristics of SKB518 in subjects with advanced solid tumors; Evaluate the immunogenicity of SKB518 in subjects with advanced solid tumors; Based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, evaluate the anti-tumor activity of SKB518 in subjects with advanced solid tumors.

Start Date26 Jun 2024

Sponsor / Collaborator

Sichuan Kelun Botai Biomedicine Co., Ltd.

100 Clinical Results associated with SKB-518

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100 Translational Medicine associated with SKB-518

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100 Patents (Medical) associated with SKB-518

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100 Deals associated with SKB-518

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