KN046

Phase 3Small molecule

JJiangsu Alphamab Biopharmaceuticals Co., Ltd

KN046 is one of 186 small molecule programs targeting Pancreatic Ductal Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

185

Competitors

Pipeline

Status by Indication[3][1]

Indication

Pancreatic Ductal AdenocarcinomaActive, not recruiting

Non-Small Cell Lung CancerTerminated

Colorectal CancerNot yet recruiting

Pancreatic CancerRecruiting

Locally AdvancedRecruiting

Pancreatic Ductal AdenocarcinomaPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Terminated

Colorectal CancerPhase 2

Not yet recruiting

Pancreatic CancerPhase 2

Recruiting

Locally AdvancedPhase 2

Recruiting

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Tabrecta

Novartis

Phase 3

8 2

Verzenio

Eli Lilly

Phase 3

7 3

Faslodex

FFresenius Kabi USA, LLC

Phase 3

4 4

KN046

JJiangsu Alphamab Biopharmaceuticals Co., Ltd

Phase 3

4 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Locally Advanced

NCT06023758

Phase 2Not yet recruiting

Colorectal Cancer

NCT05985707

Phase 2Active, not recruiting

Digestive System Cancer

NCT06099821

Q4 2027

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT05420220

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

KN046 in Patients With Advanced Non-small Cell Lung Cancer

Terminated·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 2·NCT03838848·120 enrolled

Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer

Recruiting·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 2·NCT05420220·54 enrolled

KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer

Unknown status·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 3·NCT04474119·482 enrolled

Show 1 more trial

KN046 Plus Lenvatinib in Subject With Advanced Non-Small Cell Lung Cancer in the Failure of Anti-PD-(L)1 Agent

Terminated·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 2/3·NCT05001724·16 enrolled

Hepatocellular Carcinoma2 trials

KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma

Terminated·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 1/2·NCT04601610·6 enrolled

The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

Completed·PPeking University Cancer Hospital & Institute·Phase 2·NCT04542837·55 enrolled

Esophageal Squamous Cell Carcinoma2 trials

KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Unknown status·SShanghai Chest Hospital·Phase 2·NCT03927495·100 enrolled

KN046 in Subjects With Late Stage Esophageal Squamous Cell Carcinoma

Completed·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 2·NCT03925870·45 enrolled

Thymic Carcinoma2 trials

KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma

Terminated·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 2·NCT04469725·95 enrolled

A Study of KN046 in Patients With Thymic Carcinoma Who Failed Immune Checkpoint Inhibitors

Terminated·WWeill Medical College of Cornell University·Phase 2·NCT04925947·4 enrolled

Pancreatic Cancer2 trials

Surufatinib Combined With KN046 and AG Regimen Chemotherapy as First-Line Treatment for Unresectable Advanced Pancreatic Cancer

Unknown status·SShanghai Zhongshan Hospital·Phase 1/2·NCT05832892·41 enrolled

IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer

Recruiting·IInxMed (Shanghai) Co., Ltd.·Phase 1/2·NCT05827796·70 enrolled

10 more indications

Colorectal Cancer2 trials

KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma

Not yet recruiting·PPeking University Cancer Hospital & Institute·Phase 2·NCT05985707·80 enrolled

A Phase II Multi-cohort Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib for Metastatic Microsatellite-Stable Colorectal Cancer: a Phase II Multi-cohort Study

Terminated·PPeking University Cancer Hospital & Institute·Phase 2·NCT05985109·20 enrolled

Locally Advanced1 trial

Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC

Recruiting·PPeking University·Phase 2·NCT06023758·18 enrolled

mCRC1 trial

TATE and KN046 in MCRC

Terminated·ZZhejiang Raygene Pharmaceuticals Co., Ltd·Phase 2·NCT06834399·42 enrolled

Triple-Negative Breast Cancer1 trial

A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer

Completed·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 1/2·NCT03872791·52 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma.

Active, not recruiting·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 3·NCT05149326·408 enrolled

Advanced NSCLC1 trial

Study of KN046 With Chemotherapy in First Line Advanced NSCLC

Unknown status·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 2·NCT04054531·50 enrolled

Advanced Solid Tumors1 trial

Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumor Activity of KN046 in Subjects With Advanced Solid Tumors

Unknown status·AAlphamab (Australia) Co Pty Ltd.·Phase 1·NCT03529526·21 enrolled

Gastrointestinal Tumors1 trial

A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors

Unknown status·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 1/2·NCT04612712·42 enrolled

Lymphoma1 trial

KN046 in Subjects With Advanced Solid Tumors and Lymphoma

Completed·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 1·NCT03733951·139 enrolled

Digestive System Cancer1 trial

A Phase II Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib or Apatinib for Microsatellite Instability-High Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

Active, not recruiting·PPeking University Cancer Hospital & Institute·Phase 2·NCT06099821·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for KN046. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — KN046 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for KN046. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Jiangsu Alphamab Biopharmaceuticals Co., Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: JJiangsu Alphamab Biopharmaceuticals Co., Ltd

KN046

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

Hepatocellular Carcinoma2 trials

Esophageal Squamous Cell Carcinoma2 trials

Thymic Carcinoma2 trials

Pancreatic Cancer2 trials

Colorectal Cancer2 trials

Locally Advanced1 trial

mCRC1 trial

Triple-Negative Breast Cancer1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Advanced NSCLC1 trial

Advanced Solid Tumors1 trial

Gastrointestinal Tumors1 trial

Lymphoma1 trial

Digestive System Cancer1 trial

References

Drug Info

Quick Facts

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