Delving into the Latest Updates on CK-21 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

CK21 fat emulsion, CK21脂肪乳, CK 21

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Target-

Mechanism-

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Xinkai Medicine and Chemical Intermediates (Shanghai) Co., Ltd.

Active Organization

Xinkai Medicine and Chemical Intermediates (Shanghai) Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要研究目的确定CK21在晚期恶性实体肿瘤患者的安全性、耐受性，以及II期临床试验推荐剂量（RP2D）。次要研究目的（1）确定CK21在晚期恶性实体肿瘤患者的药代动力学及药效动力学特征。（2）评估CK21在晚期恶性实体肿瘤患者的初步疗效。探索性研究目的（1）探索潜在预测疗效的生物标志物的水平及其与疗效的关系。（2）探索分析PK与药效动力学的关系。

[Translation]

Main study objectives To determine the safety, tolerability and recommended dose (RP2D) of CK21 in patients with advanced malignant solid tumors. Secondary study objectives (1) To determine the pharmacokinetic and pharmacodynamic characteristics of CK21 in patients with advanced malignant solid tumors. (2) To evaluate the preliminary efficacy of CK21 in patients with advanced malignant solid tumors. Exploratory study objectives (1) To explore the levels of potential biomarkers predicting efficacy and their relationship with efficacy. (2) To explore and analyze the relationship between PK and pharmacodynamics.

Start Date12 Jan 2023

Sponsor / Collaborator

Xinkai Medicine and Chemical Intermediates (Shanghai) Co., Ltd.

ChiCTR2200064476 / SuspendedPhase 1IIT

The Phase Ia Clinical Trial to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CK21 Fat Emulsion Injection Administered in Single and Multiple Doses in Patients with Advanced Malignant Solid Tumors

Start Date09 Oct 2022

Sponsor / Collaborator