KN046

DRUG19 trials

Sponsors

Alphamab (Australia) Co Pty Ltd., Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Shanghai Chest Hospital, Peking University Cancer Hospital & Institute, Weill Medical College of Cornell University

Conditions

Advanced Non-small Cell Lung CancerAdvanced Pancreatic Ductal AdenocarcinomaAdvanced Solid TumorsColorectal CancerDigestive System CancersEsophageal Squamous Cell CarcinomaHCCHER2-positive Biliary Tract Cancer

Phase 1

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

Alphamab (Australia) Co Pty Ltd.Advanced Solid Tumors

Start: 2018-05-21End: 2020-03-30Target: 21Updated: 2018-05-22

KN046 in Subjects With Advanced Solid Tumors and Lymphoma

CompletedNCT03733951

Jiangsu Alphamab Biopharmaceuticals Co., LtdAdvanced Solid Tumors, Lymphoma

Start: 2018-12-18End: 2023-02-02Updated: 2023-06-09

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

CompletedNCT03872791

Jiangsu Alphamab Biopharmaceuticals Co., LtdTriple-negative Breast Cancer

Start: 2019-05-30End: 2022-10-27Updated: 2023-06-08

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

RecruitingNCT05827796

InxMed (Shanghai) Co., Ltd.Pancreatic Cancer

Start: 2022-12-08End: 2026-03-31Target: 70Updated: 2025-04-30

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

Shanghai Zhongshan HospitalUnresectable Locally Advanced or Metastatic Pancreatic Cancer

Start: 2023-11-01End: 2025-06-01Target: 41Updated: 2024-06-14

Phase 2

KN046 in Patients With Advanced Non-small Cell Lung Cancer

TerminatedNCT03838848

Jiangsu Alphamab Biopharmaceuticals Co., LtdStage IV Non-small Cell Lung Cancer

Start: 2019-05-05End: 2022-07-30Updated: 2023-03-02

KN046 in Subjects With Late Stage Esophageal Squamous Cell Carcinoma

CompletedNCT03925870

Jiangsu Alphamab Biopharmaceuticals Co., LtdEsophageal Squamous Cell Carcinoma

Start: 2019-06-21End: 2022-07-04Updated: 2022-08-05

KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Shanghai Chest HospitalEsophageal Squamous Cell Carcinoma

Start: 2019-05-22End: 2021-12-31Target: 100Updated: 2019-05-29

Study of KN046 With Chemotherapy in First Line Advanced NSCLC

Jiangsu Alphamab Biopharmaceuticals Co., LtdNon-small Cell Lung Cancer

Start: 2019-09-04End: 2021-06-01Target: 50Updated: 2019-09-10

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

TerminatedNCT04469725

Jiangsu Alphamab Biopharmaceuticals Co., LtdThymic Carcinoma

Start: 2020-12-02End: 2023-07-07Updated: 2024-03-12

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

CompletedNCT04542837

Peking University Cancer Hospital & InstituteHCC

Start: 2020-09-11End: 2024-03-15Updated: 2024-09-19

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

TerminatedNCT04925947

Weill Medical College of Cornell UniversityThymic Carcinoma

Start: 2021-12-13End: 2023-05-05Updated: 2024-04-16

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

TerminatedNCT05001724

Jiangsu Alphamab Biopharmaceuticals Co., LtdAdvanced Non-small Cell Lung Cancer

Start: 2021-10-28End: 2023-04-07Updated: 2023-04-25

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

Not yet recruitingNCT05985707

Peking University Cancer Hospital & InstituteHER2-positive Biliary Tract Cancer, HER2-positive Colorectal Cancer

Start: 2023-08-15End: 2026-12-31Target: 80Updated: 2023-08-21

KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer

RecruitingNCT05985109

Peking University Cancer Hospital & InstituteColorectal Cancer

Start: 2023-10-26End: 2026-12-31Target: 98Updated: 2023-10-26

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

RecruitingNCT06023758

Peking UniversityHER2-positive Locally Advanced Resectable Gastric Cancer

Start: 2023-09-22End: 2026-12-31Target: 18Updated: 2024-05-10

KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

RecruitingNCT06099821

Peking University Cancer Hospital & InstituteDigestive System Cancers

Start: 2023-10-25End: 2026-12-31Target: 39Updated: 2023-10-26

Phase 3

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

Jiangsu Alphamab Biopharmaceuticals Co., LtdSquamous Non-small-cell Lung Cancer

Start: 2020-09-14End: 2023-08-30Updated: 2021-11-24

KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma.

Active, not recruitingNCT05149326

Jiangsu Alphamab Biopharmaceuticals Co., LtdAdvanced Pancreatic Ductal Adenocarcinoma

Start: 2022-01-20End: 2024-08-30Target: 408Updated: 2024-03-26

Related Papers

Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): A single-arm, phase 1b/2 trial.

Journal of Clinical Oncology2025-05-28

The anti-PD-L1/CTLA-4 bispecific antibody KN046 plus lenvatinib in advanced unresectable or metastatic hepatocellular carcinoma: a phase II trial

Nature Communications2025-02-0723 citations

KN046, a bispecific antibody against PD-L1 and CTLA-4, plus chemotherapy as first-line treatment for metastatic NSCLC: A multicenter phase 2 trial

Cell Reports Medicine2024-03-0134 citations

The anti-PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel in first-line treatment of metastatic triple-negative breast cancer: a multicenter phase II trial

Nature Communications2024-02-0363 citations

Efficacy and safety of KN046, a novel bispecific antibody against PD-L1 and CTLA-4, in patients with non-small cell lung cancer who failed platinum-based chemotherapy: a phase II study.

2023-06-0516 citations

Phase I trial of KN046, a novel bispecific antibody targeting PD-L1 and CTLA-4 in patients with advanced solid tumors

Journal for ImmunoTherapy of Cancer2023-06-0140 citations

Abstract PD11-10: PD11-10 Efficacy, Safety, and Tolerability of KN046 (an anti-PD-L1/CTLA-4 Bispecific Antibody) in combination with Nab-paclitaxel in Metastatic Triple-negative Breast Cancer (mTNBC):Final results of the Phase II trial

Cancer Research2023-03-012 citations

Spatial multi-omics revealed the impact of tumor ecosystem heterogeneity on immunotherapy efficacy in patients with advanced non-small cell lung cancer treated with bispecific antibody

Journal for ImmunoTherapy of Cancer2023-02-0155 citations

A phase II study combining KN046 (an anti-PD-L1/CTLA-4 bispecific antibody) and lenvatinib in the treatment for advanced unresectable or metastatic hepatocellular carcinoma (HCC): Updated efficacy and safety results.

Journal of Clinical Oncology2022-06-0115 citations

A multicenter, randomized, double-blind phase III clinical study to evaluate the efficacy and safety of KN046 combined with nab-paclitaxel and gemcitabine versus placebo combined with nab-paclitaxel and gemcitabine in patients with advanced pancreatic cancer (ENREACH-PDAC-01).

Journal of Clinical Oncology2022-06-019 citations

Phase II study of KN046 in patients with thymic carcinoma who failed immune checkpoint inhibitors.

Journal of Clinical Oncology2022-06-011 citations

Abstract 1660: Preliminary safety tolerability & efficacy results of KN046 (an anti-PD-L1/CTLA-4 bispecific antibody) in combination with Nab-paclitaxel in patients with metastatic triple-negative breast cancer (mTNBC)

Cancer Research2021-07-019 citations

A phase 2, open-label, multicenter study to evaluate the efficacy, safety, and tolerability of KN046 in combination with chemotherapy in subjects with advanced non-small cell lung cancer.

Journal of Clinical Oncology2021-05-209 citations

Efficacy and safety of KN046 plus paclitaxel/cisplatin as first-line treatment for unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

Journal of Clinical Oncology2021-05-205 citations

The preliminary efficacy and safety data of KN046 in patients failed on prior immune checkpoint inhibitors therapy.

Journal of Clinical Oncology2020-05-2029 citations

Preliminary safety, efficacy, and pharmacokinetics (PK) results of KN046 (bispecific anti-PD-L1/CTLA4) from a first-in-human study in subjects with advanced solid tumors.

Journal of Clinical Oncology2019-05-2016 citations