CA-102N(CA-102N) - 药物靶点：Akt x CD44 x ERK x MEK x PI3Ks x mTOR_在研适应症：转移性结直肠癌，膀胱癌，胰腺导管腺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

靶点

Akt x CD44 x ERK x MEK x PI3Ks x mTOR

作用方式

抑制剂

作用机制

Akt 抑制剂(原癌基因蛋白c-akt 抑制剂)、CD44抑制剂(CD44抗原抑制剂)、ERK抑制剂(ERK subfamily inhibitors)

+ [3]

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [2]

在研适应症

转移性结直肠癌膀胱癌胰腺导管腺癌+ [1]

非在研适应症

局部晚期恶性实体瘤肿瘤转移

原研机构

禾伸堂生技股份有限公司

在研机构

禾伸堂生技股份有限公司

非在研机构-

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 CA-102N 相关的临床试验

NCT05274204

/ Temporarily not availableN/A

Expanded Access to CA102N in One Patient Who Completed at Least 12 Cycles of Combination Therapy of CA102N Plus Lonsurf in Clinical Study Number of HS-CA102N-101

This study is an individual patient expanded access protocol that the subject enrolled had completed the combination treatment of CA102N plus Lonsurf for at least 12 cycles.

开始日期-

申办/合作机构

禾伸堂生技股份有限公司

NCT06039202

/ Not yet recruiting临床2期

A Phase 2, Randomized, Open Label Study to Evaluate Efficacy, Safety, and Tolerability of CA102N Combined With Trifluridine/Tipiracil (TAS-102) Compared to Bevacizumab Combined With TAS-102 in Subjects With Metastatic Colorectal Cancer (mCRC) Who Failed the Standard Treatment

HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy).

开始日期2024-01-01

申办/合作机构

禾伸堂生技股份有限公司

NCT03616574

/ Completed临床1期

Phase 1,Two-part (Dose Escalation, Dose Expansion), Multicenter,Non-randomized,Open-label, Multiple Dose, First-in-human Study of CA102N Monotherapy and of CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors

Study HS-CA102N-101 is a phase 1, two part (dose escalation, dose expansion), multicenter, non-randomized, open-label, multiple dose, first-in-human study of CA102N monotherapy and of CA102N combined with trifluridine/tipiracil (LONSURF) in subjects with advanced solid tumors.
CA102N will be evaluated in subjects with locally advanced or metastatic solid tumours for which no effective therapy is available in Part 1 (dose escalation) and in subjects with relapsed or refractory locally advanced or metastatic colorectal cancer (mCRC) after prior oxaliplatin and irinotecan-based chemotherapy in Part 2 (dose expansion).

开始日期2019-04-09

申办/合作机构

禾伸堂生技股份有限公司

100 项与 CA-102N 相关的临床结果

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100 项与 CA-102N 相关的转化医学

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100 项与 CA-102N 相关的专利（医药）

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1

项与 CA-102N 相关的文献（医药）

2023-02-01·Investigational New Drugs

Phase 1 study of the safety, pharmacokinetics, and preliminary efficacy of CA102N as monotherapy and in combination with trifluridine-tipiracil in patients with locally advanced or metastatic solid tumors

Article

作者: Pant, Shubham ; Kopetz, Scott ; Chen, Yuchih C ; Jimeno, Antonio ; Tchaparian, Eskouhie ; Dragovich, Tomislav ; Menter, David ; Lieu, Christopher ; Kundranda, Madappa

CA102N is a covalently bound conjugate of modified nimesulide (Nim) and NaHA, the sodium salt of hyaluronic acid (HA). HA is a natural ligand of cluster of differentiation 44 (CD44), which is over-expressed in colorectal cancer (CRC). CA102N is designed to deliver nimesulide directly to the tumor via the interaction of HA and CD44. A Phase 1, 2-part (dose escalation, dose expansion), non-randomized, open-label, first-in-human study of CA102N, as monotherapy and in combination with trifluridine-tipiracil, was conducted in patients with locally advanced or metastatic solid tumors. The CA102N doses evaluated were 0.36 mg/kg, 0.54 mg/kg, and 0.72 mg/kg Nim equivalent. The primary endpoints were dose-limiting toxicities (DLTs) in Cycle 1 as well as serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) throughout the study; secondary endpoints were pharmacodynamics parameters, objective tumor response, and urinary pharmacodynamics markers of target inhibition. Between April 2019 and October 2021, 37 patients were enrolled in 3 US centers. No DLTs were observed in Part 1, and 0.72 mg/kg Nim equivalent was the dose selected for Part 2. In total, 52 TEAEs in 18 patients were CA102N-related; 4 (in 3 patients) were ≥ Grade 3. Exploratory analysis in the dose expansion cohort revealed a median progression-free survival of 3.7 (1.0, 6.77) months. Based on this study, CA102N as monotherapy or in combination with trifluridine-tipiracil, was safe and well-tolerated at the recommended Phase 2 dose of 0.72 mg/kg Nim equivalent in patients with locally advanced or metastatic solid tumors. Preliminary evidence of antitumor activity in CRC warrants further clinical development. (ClinicalTrials.gov registration number: NCT03616574. Registration date: August 6, 2018).

100 项与 CA-102N 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
转移性结直肠癌	临床2期	-	禾伸堂生技股份有限公司	2024-01-01
膀胱癌	临床前	中国台湾	禾伸堂生技股份有限公司	2024-09-06
胰腺导管腺癌	临床前	中国台湾	禾伸堂生技股份有限公司	2024-09-06
三阴性乳腺癌	临床前	中国台湾	禾伸堂生技股份有限公司	2024-09-06
局部晚期恶性实体瘤	临床前	美国	禾伸堂生技股份有限公司	2019-04-09
肿瘤转移	临床前	美国	禾伸堂生技股份有限公司	2019-04-09