Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

KN026

KN046

Oxaliplatin 130mg/m2 d1，Capecitabine 1000mg/m2 d1-14，Q3W

XELOX

Shen Lin, Professor

Shen Lin, professor

This is a multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma.

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, resulting in dual HER2 signaling blockade.KN046 is a PD-L1 - CTLA-4 bispecific antibody. The trial consists of two groups. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W in Group 1. If the statistical hypothesis is not met in Group 1, patients will be enrolled in Group 2. Patients in group 2 will receive KN026+KN046+XELOX.

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

A Multicenter II Study to Compare KN026 and KN046 Versus Oxaliplatin, Capecitabine Combined KN026 and KN046 in Patients With HER2-positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.

Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)

Event-free survival (assessed by the investigator per RECIST v1.1 criteria)

Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)

Peking University

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Disease Attributes

Trastuzumab

Docetaxel

Pertuzumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Subjects will receive an intravenous (IV) infusion of KN026 plus HB1801. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurrs first.

On Day 1 of each 21-day cycle, patients will receive an intravenous (IV) infusion of Pertuzumab 840 mg loading dose followed by 420 mg per cycle, IV, D1, Q3W, in combination with trastuzumab 8 mg/kg loading dose followed by 6 mg/kg per cycle, IV, D1, Q3W and docetaxel 75 mg/m\^2. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurred first.

HB1801

840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion

8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion

Clinical Trials Information Group Officer

fenglin She

This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).

The purpose of this study is to assess the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer. This study will establish an independent data monitoring committee (IDMC) to conduct safety assessments after approximately 20 subjects in the treatment group complete the first cycle of treatment. During the safety assessment period, the study will continue to enroll subjects, and safety review meetings will be at 1 year of randomization in the first subject. In addition, the IDMC plans to conduct one interim analysis of efficacy during the study period.

The primary study hypotheses are that the combination of KN026 combined with HB1801 is superior to trastuzumab combined with pertuzumab and docetaxel with respect to: Progression-free Survival (PFS) as assessed by the BIRC per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.

A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.

Shanghai JMT-Bio Inc.

Patient will be intravenously administrated with one dose of KN026. dosing interval may be adjusted during the study based on emerging data from this trial and/or from other trial.

This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. There are 5 proposed dose levels which are 5, 10, 15, 20 and 30 mg/kg, but dosing interval may be adjusted during the study (such as QW, OR Q2W, OR Q3W) based on emerging data from this trial and/or from phase 1 trial of KN026 in other country. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or if MTD is not found, dose escalation will continue until the MAD of 20 mg / kg is reached. Dose expansion will carried out in 20 mg/kg Q2W and 30 mg/kg Q3W.

Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer

A Single Arm, Open Lable, Dose Escalation Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Preliminary Efficacy of KN026 Monotherapy in Patients With HER2-positive Advanced Malignant Breast and Gastric Cancer

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Fulvestrant

Palbociclib

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Protein Kinase Inhibitors

Enzyme Inhibitors

KN026 20 mg/kg + palbociclib125 mg/day+Fulvestrant 500 mg (Patients with HR+/HER2-positive MBC )

KN026 20 mg/kg + palbociclib +Fulvestrant 500 mg(Patients with HR+/HER2-positive MBC )

HR+/HER2-positive MBC will be treated by KN026 20 mg/kg+Palbociclib+fulvestrant 500 mg

KN026 combined with Palbociclib and Fulvestrant

This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The subjects will receive 20 mg/kg IV Q2W+ palbociclib 100/125 mg/day orally+/-Fulvestrant 500 mg IM until progressive disease, unacceptable toxicity or death.

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.

ctDNA and single cell sequencing analysis may be performed using plasma samples collected from subjects at baseline and upon disease progression.

Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer

A Phase II Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Locally Advanced HER2-positive Breast Cancer

The proportion of patients experiencing dose limiting toxicities

ORR as assessed by the investigator according to RECIST 1.1

clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria

KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles

Benlong Yang, professor

Jiong Wu, professor

This is an open-lable, multicenter, and single arm phase II trial to evaluate treatment with KN026 plus docetaxel as neoadjuvant therapy in patients with early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) HER2-positive breast cancer. The subjects will receive KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.

Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in Patients With Early-stage or Locally Advanced HER2-positive Breast Cancer

total pathological complete response as assessed by local pathologist

breast pathological complete response assessed by local pathologist

Objective response rate as assessed by the investigator according to RECIST 1.1

Incidence, type, and severity of adverse events and serious adverse events

Carcinoma

Colorectal Neoplasms

Biliary Tract Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Biliary Tract Diseases

Biliary Tract Cancer

Antibodies

Antibodies, Bispecific

Immunoglobulins

Arm A will include HER2-positive treatment-naive metastatic colorectal cancer patients, and the patients in this cohort will receive XELOX and KN026 treatment.

Arm B will include HER2-positive treatment-naive metastatic colorectal cancer patients, and the patients in this cohort will receive XELOX and KN026 + KN046 treatment.

Arm C will include HER2-positive treatment-naive metastatic biliary tract cancer patients, and the patients in this cohort will receive XELOX and KN026 + KN046 treatment.

KN026 is a novel bispecific antibody that simultaneously binds to two distinct HER2 epitopes.

KN046 is a novel bispecific antibody that blocks both PD-L1 interaction with PD-1 and CTLA-4 interaction with CD80/CD86.

XELOX is the standard first-line chemotherapy in metastatic colorectal cancer and biliary duct cancer.

Jian Li

Xicheng Wang

Ting Xu, MD

Zhenghang Wang, MD

Lin Shen

The goal of this Interventional clinical trial is to learn about the efficacy and safety of KN026 and chemotherapy ± KN046 in HER2-positive metastatic colorectal cancer and biliary tract cancer. Participants will receive standard first-line chemotherapy (capecitabine + oxaliplatin) combined with KN026 (a HER2-targeted bispecific antibody) ± KN046 （a PD-L1/CTLA-4 targeted bispecific antibody）.

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

The Efficacy and Safety of KN026 Combination Chemotherapy ± KN046 in HER2-Positive Advanced Colorectal Cancer and Biliary Tract Cancer as First-Line Treatment： a Phase Ⅱ Study

Objective response rate (defined as CR+PR) is reported based on investigator's evaluation.

Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) or death due to any cause.

Duration of response (DOR) is defined as the time from the date of the first response to the first objective documentation of radiographic progressive disease (PD) or death due to any cause.

Disease control rate (defined as CR+PR+SD) is reported based on investigator's evaluation.

Time to response (TOR) is defined as the time from the date of the first dose to the first objective documentation of radiographic objective response.

Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause.

A treatment-emergent adverse event (TEAE) is defined as any adverse event not present prior to the initiation of drug treatment or any adverse event already present that worsens in intensity or frequency following exposure to the drug treatment. TEAEs were graded using National Cancer Institute (NCI)-CTCAE version 4.03.

Peking University Cancer Hospital & Institute

Professor

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.

KN046 is a PD-L1 - CTLA-4 bispecific antibody.

KN026 and KN046 are given at 20mg/Kg and 3mg/Kg intravenously on day 1of each 2 weeks cycle at the beginning respectively.The dosage will be escalated if adverse events are tolerated according to the scheme.

KN026 combined with KN046

Lin Shen, MD,PhD

This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.

The study is composed of 2 stages. Stage 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 consists of 4 tumor type expansion cohorts for expanding the information on clinical safety, clinical pharmacokinetics and antitumor activity in HER2 positive patients.

KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor

A Phase Ib Study to Evaluate Efficacy, Safety and Tolerability of KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor

Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment

Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC	NCT06023758	HER2-positive L...	KN026 KN046 XELOX	18 Years - 75 Years	Peking University
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.	NCT05838066	First-line Trea...	KN026 HB1801 Pertuzumab Trastuzumab Docetaxel	18 Years -	Shanghai JMT-Bio Inc.
Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC	NCT06023758	HER2-positive L...	KN026 KN046 XELOX	18 Years - 75 Years	Peking University
Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer	NCT03619681	Breast Cancer Gastric Cancer	KN026	18 Years - 75 Years	Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer	NCT04778982	HER2-positive M...	KN026 combined ...	18 Years - 75 Years	Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer	NCT04881929	Breast Cancer	KN026	18 Years -	Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer	NCT04881929	Breast Cancer	KN026	18 Years -	Jiangsu Alphamab Biopharmaceuticals Co., Ltd
KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma	NCT05985707	HER2-positive C... HER2-positive B...	KN026 KN046 XELOX	18 Years -	Peking University Cancer Hospital & Institute
KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor	NCT04040699	HER2 Positive S...	KN026 combined ...	18 Years - 75 Years	Peking University
Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC	NCT06023758	HER2-positive L...	KN026 KN046 XELOX	18 Years - 75 Years	Peking University
Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer	NCT04881929	Breast Cancer	KN026	18 Years -	Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer	NCT03619681	Breast Cancer Gastric Cancer	KN026	18 Years - 75 Years	Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Spots Global Cancer Trial Database for kn026

Every month we try and update this database with for kn026 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for kn026

Every month we try and update this database with for kn026 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for kn026 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.