Delving into the Latest Updates on CAN-1012 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

3-((4-((4-amino-2-butyl-1H-imidazo[4,5-c]quinolin-1-yl)oxy)butyl)(3- (dimethylamino)propyl)amino)-4-(heptadecylamino)cyclobut-3-ene-1,2-dione, CAN 1012, CAN-1012

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Target

TLR7

Action

agonists

Mechanism

TLR7 agonists(Toll like receptor 7 agonists)

Therapeutic Areas

NeoplasmsInfectious DiseasesDigestive System Disorders+ [3]

Active Indication

Breast CancerLiposarcomaMelanoma+ [14]

Inactive Indication

Neoplasm Metastasis

Originator Organization

CanWell Pharma Co., Ltd.

Active Organization

IriSys, Inc.

CanWell Pharma Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States)

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主要目的： 1) 评估CAN1012注射液在晚期实体瘤患者中的安全性和耐受性； 2) 确定最大耐受剂量（MTD）和/或Ⅱ期推荐剂量（RP2D）。次要目的： 1) 评估CAN1012注射液在晚期实体瘤患者中的药代动力学（PK）特征； 2) 评估CAN1012注射液在晚期实体瘤患者中的初步有效性。探索性目的： 1) 评估CAN1012注射液在晚期实体瘤患者中的药效动力学（PD）特征； 2) 探索生物标志物（包括CD3、CD8、PD-L1、BDCA2）与CAN1012注射液有效性的相关性。

[Translation]

Primary objectives: 1) To evaluate the safety and tolerability of CAN1012 injection in patients with advanced solid tumors; 2) To determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D). Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of CAN1012 injection in patients with advanced solid tumors; 2) To evaluate the preliminary efficacy of CAN1012 injection in patients with advanced solid tumors. Exploratory objectives: 1) To evaluate the pharmacodynamic (PD) characteristics of CAN1012 injection in patients with advanced solid tumors; 2) To explore the correlation between biomarkers (including CD3, CD8, PD-L1, BDCA2) and the efficacy of CAN1012 injection.

Start Date09 Sep 2022

Sponsor / Collaborator

IriSys, Inc.

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100 Clinical Results associated with CAN-1012

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100 Translational Medicine associated with CAN-1012

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100 Patents (Medical) associated with CAN-1012

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100 Deals associated with CAN-1012

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Malignant Solid Neoplasm	Phase 2	China	CanWell Pharma Co., Ltd.	27 Jun 2024
Breast Cancer	Phase 2	China	CanWell Pharma Co., Ltd.	-
Liposarcoma	Phase 2	China	CanWell Pharma Co., Ltd.	-
Melanoma	Phase 2	China	CanWell Pharma Co., Ltd.	-
Ductal Carcinoma	Phase 1	United States	CanWell Pharma Co., Ltd.	01 May 2026
Noninfiltrating Intraductal Carcinoma	Phase 1	United States	CanWell Pharma Co., Ltd.	01 May 2026
Advanced Malignant Solid Neoplasm	Phase 1	China	IriSys, Inc.	09 Sep 2022
Colorectal Cancer	Phase 1	China	IriSys, Inc.	09 Sep 2022
Colorectal Cancer	Phase 1	China	CanWell Pharma Co., Ltd.	09 Sep 2022
Merkel Cell Carcinoma	Phase 1	China	CanWell Pharma Co., Ltd.	09 Sep 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04987112 (ESMO2025)	Phase 1	Advanced Malignant Solid Neoplasm	47	CAN1012	xwltjhmkbz(tcovelnytj) = chdalvjlzr pvzcanwgmc (usnrvgfaym ) View more	Positive	17 Oct 2025
NCT04987112 \| CTR20222322	Phase 1	Solid tumor	21	CAN1012	ciazklbxyq(wljvpwtlcl) = xcwvfshyzj ohgyrknaoc (egmeankeve ) View more	Positive	05 Nov 2024