All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1.0, 2.5, 5.0 and 10 mg/kg weekly. Dose escalation will continue until identification of MTD up to a maximum dose of 10 mg/kg.

Four cohorts dosed at 1.0 mg/kg, 2.5 mg/kg, 5.0 mg/kg, and 10 mg/kg weekly. All cohorts are administered by subcutaneous injection (SC).

KN035

This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in Japanese patients with advanced and metastatic solid tumor. The dose escalation will follow the widely used 3+3 design.

This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in Japanese patients with advanced and metastatic solid tumor.

The dose escalation will follow the widely used 3+3 design. Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1.0, 2.5, 5.0 and 10 mg/kg weekly. Dose escalation will continue until identification of MTD up to a maximum dose of 10 mg/kg. MTD is defined as the highest dose studied at which no more than 1 of 6 subjects has experienced a dose-limiting toxicity (DLT) in Cycle 1. The enrolled patients are managed under hospitalization for DLT observation period (C1 28 days). If no DLTs occur in a cohort of 3 subjects, a new cohort of 3 subjects will be treated at the next higher dose level. If 1 of 3 subjects in a cohort experiences a DLT, that cohort will be expanded to 6 subjects. If only 1 of the 6 subjects has a DLT, then the next cohort of 3 subjects will be treated at the next higher dose level. If 2 or more DLTs occur within a cohort, then that dose level will be above the MTD, and the previous lower (tolerated) dose level will be considered the MTD if ≤ 1 in 6 subjects has a DLT.

A subject who withdraws from the study during Cycle 1 for reasons other than a DLT will be replaced.

Subjects will be monitored for safety and efficacy throughout the study. After radiological tumor assessment at Screening, the first radiological assessment of tumor response status will be performed at Week 12 (± 1 week), unless there is clinical indication warranting earlier radiologic imaging. The same imaging technique used at baseline has to be used throughout the study.

Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1.0, 2.5, 5.0 and 10 mg/kg of KN035 weekly.

A Study of PD-L1 Antibody KN035 in Japanese Subjects With Locally Advanced or Metastatic Solid Tumors

A Phase I, Open Label, Dose Escalation Study of The Safety and Pharmacokinetics of Anti-PD-L1 Monoclonal Antibody KN035 Administered in Subcutaneous Injection as A Single Agent to Japanese Subjects With Locally Advanced or Metastatic Solid Tumors

The safety of KN035 will be assessed throughout the study by monitoring adverse events (AEs) per the NCI-CTC-AE Version 4.03, physical examination, electrocardiograms, laboratory measurements and severity of adverse events.

3D Medicines (Sichuan) Co., Ltd.

Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging.

89Zr-KN035

Hua Zhang

Yicong Bian

Liyan Miao, PhD

Jianan Huang, PhD

This is a single arm study by using 89Zr-labeled KN035 (89Zr-KN035) PET imaging to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors.

The overall purpose of the study is to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors by using PET imaging. Safety will be observed after 89Zr-KN035 injection, and radiation dosimetry of 89Zr-KN035 will be calculated.

89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors

89Zr-labeled KN035 PET Imaging in Patients With PD-L1positive Advanced Solid Tumors

Blood samples will be collected and assessed by timepoints.

All adverse events will be assessed by CTCAE v 4.03 and evaluated if treatment-related or not.

Laboratory tests (blood, urine) will be conducted by time. Significant changes will be assessed by CTCAE v 4.03.

Vital signs (heart rate, respiratory rate, blood pressures and body temperature) data will be collected by time. Significant changes will be assessed by CTCAE v4.03.

MITRO Biotech Co., Ltd.

The First Affiliated Hospital of Soochow University

Professor

Pharmaceutical Solutions

KN035 is to be injected subcutaneously 0.1mg/kg or 0.3mg/kg or 1mg/kg or 2.5mg/kg or 5mg/kg or 10mg/kg weekly until disease progresses or unacceptable tolerability occurs.

KN035 is a monoclonal antibody drug which is formulated for subcutaneous injection in a single-use vial (brown neutral borosilicate) containing a total of 300 mg antibody in 1.5 ml of solution.

jianming xu

This dose escalation and dose expansion study is to evaluate and characterize the tolerability and safety profile of single agent KN035 in Chinese adult subjects with unresectable advanced carcinoma.

Dose escalation study is to evaluate the safety and tolerability of KN035 in advanced and metastatic solid tumor. Six dose levels are planned and include: 0.1, 0.3, 1.0, 2.5, 5, 10 mg/kg/dose. Subjects will be assigned to a dose level in the order of study entry. The first cohort of 1 subject will receive KN035 at 0.1 mg/kg/dose as a subcutaneous (sc) injection every week for a total of 4 injections (Days 1, 8, 15 and 22) in the first 28-day cycle. For the first 2 cohorts (0.1 and 0.3 mg/kg/dose), only one subject will be enrolled in each cohort until 1 subject experiences a ≥ Grade 2 drug-related adverse event in the first cycle, then 2 additional subjects will be enrolled at this cohort. Thereafter, the study will become the traditional 3+3 design with 3 or 6 subjects treated at this dose level and all subsequent dose levels depending upon the incidence of DLTs. However, if no ≥ Grade 2 drug-related adverse event occurs in the first 2 cohorts, starting with cohort 3, the study will become the traditional 3+3 design with 3 or 6 subjects enrolled.

Dose expansion-1 study is planned to conduct in advanced hepatocellular cancer subjects at 2.5 mg/kg and 5 mg/kg dose level, respectively.

Dose expansion-2 study is planned to conduct in advanced solid tumor subjects at 2.5 mg/kg and 5 mg/kg dose level, respectively

Phase I Study of KN035 in Chinese Subjects With Advanced Solid Tumors

A Phase I, Single Arm, Multiple Dose, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KN035 Administered in Subcutaneous Injection as a Single Agent to Subjects With Advanced Solid Tumors

Neoplasms

All Conditions

Neoplasms, Multiple Primary

KN035150mg，once a week, subcutaneously. Every 28 days is a treatment cycle.KN035 can be used for up to 2 years.

Haiyan Yang, doctor

This study is a prospective, single arm, single center exploratory clinical research, to evaluate KN035 late treatment in patients with Multiple Primary tumors (MPC, Multiple Primary working) clinical benefit.In the study, all subjects meeting the criteria for inclusion will be enrolled in the KN035 treatment group, and patients cannot receive any other anti-tumor treatment during the study period.The primary endpoint of the study was defined as patients who could be assessed by imaging, and the optimal Objective Response Rate (ORR) based on RECIST 1.1 standard, while the secondary endpoint was safety (nci-ctcae 4.0), DCR (Disease Control Rate), DoR (Duration of Response), progression-free survival (PFS),1) Overall Survival and Overall Survival;The end point of the exploratory study was the correlation between different molecular types and the efficacy of immunotherapy.

Patients diagnosed with advanced MPC in the study should be enrolled as:

Histopathological diagnosis of multiple primary tumors, and is currently suffering from advanced colorectal cancer;Except for bowel cancer, no anti-tumor treatment is needed for other tumors during screening.

The maximum time interval between screening and treatment was 2 weeks (±7 days).Efficacy and safety were evaluated at 4 weeks (±7 days), 8 weeks (±7 days) after treatment, and every 8 weeks (±7 days) thereafter.Once a subject develops disease progression (based on investigator evaluation or imaging evidence), the subject should discontinue the study.Cessation of treatment for any reason should be followed by a study end visit within 4 weeks (±7) days after the last study administration to collect information on all possible adverse events and drug combinations.Drug - related or possibly related adverse events should be followed up until they are stable or resolved.SAE should be documented within 30 days of study cessation.KN035 can be used for up to 2 years.

When desease progression is suspected, researchers are allowed to reconfirm disease progression after 4 weeks using irRECIST criteria.During the confirmation of disease progression, if the investigator decides that the subject should continue to receive KN035 treatment, the following criteria must be met:

The researchers assessed whether the subjects had benefited or were likely to continue to benefit:

①Subjects can tolerate study drug therapy;

②There were no medical events (e.g., central nervous system metastases) in which tumor progression was rapid or urgent intervention was required.

Study endpoint analysis will be performed when the last patient is followed for 24 weeks or disease progression or death is observed.If there is still no disease progression or intolerable adverse reactions, the patient will continue to receive KN035 treatment until the disease progression, death, occurrence of intolerable adverse reactions or treatment for 1 year (the researcher will give follow-up treatment recommendations according to the specific situation, if the original treatment is continued, the patient can still receive KN035 treatment for free).Treatment options after disease progression will be implemented at the discretion of the investigator.After the end of the study visit, subjects will enter the post-study follow-up period to collect survival data OS.

KN035 in Patients With Advanced Multiple Primary Tumors

A Prospective Single Arm Exploratory Clinical Research on the Efficacy and Safety of KN035 in Patients With Advanced Multiple Primary Tumors

RenJi Hospital

ONCOLOGY DEPT.

Symptoms and General Pathology

Microsatellite Instability

patients receive 600 mg of the KN035 Subcutaneously every 3 weeks

Lin Shen, MD

In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy.

For colorectal cancer participants, who are required to have been previously treated with standard therapies , other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.

Later-line therapies after failure of standard treatments for advanced colorectal and non-colorectal cancer patients are limited. Mismatch repair (MMR) deficiency or microsatellite instability-high (MSI-H) played a role of positive predictive factor, which had been documented after the pembrolizumab and nivolumab trial were reported, for PD-1 blockade monotherapy in patients with advanced colorectal and non-colorectal cancers.

In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy.

For colorectal cancer participants, who are required to have been previously treated with standard therapies. For other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.

KN035 for dMMR/MSI-H Advanced Solid Tumors

Study of KN035 as Monotherapy in Patients With Advanced Mismatched Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors

per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by central imaging vendor

per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by investigator

per RECIST 1.1 assessed by central imaging vendor and investigator

per RECIST 1.1 assessed by central imaging vedor and investigator

Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1, 2.5, 5 and 10 mg/kg weekly.

David Liu, M.D.

This is an open label, dose escalation study to evaluate the safety and tolerability of KN035 in advanced and metastatic solid tumor.

The dose escalation will follow the traditional 3+3 design. Cohorts of 3-6 subjects will be enrolled sequentially at escalating doses of 1, 2.5, 5 and 10 mg/kg weekly. Dosing schedule for cohorts 2 and above may change after interim PK analysis after Cohort 1 Cycle 1 to bi-weekly or other regimen based on elimination profile of KN035 to avoid excessive drug accumulation. Dose escalation will continue until identification of MTD, up to a maximum dose of 10 mg/kg. MTD is defined as the highest dose studied at which no more than 1 of 6 subjects has experienced a dose-limiting toxicity (DLT) in Cycle 1.

Phase 1 Study of Anti-PD-L1 Monoclonal Antibody KN035 to Treat Locally Advanced or Metastatic Solid Tumors

A Phase I, Open Label, Dose Escalation Study of The Safety and Pharmacokinetics of Anti-PD-L1 Monoclonal Antibody KN035 Administered in Subcutaneous Injection as A Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors

Blood samples will be collected at Pre-dose, 6hrs,24 hrs,48hrs,96hrs after the end of the first injection of KN035, after injection of KN035 at Day 8, 15, 22 in first cycle and pre-dose and within 24hrs of following cycles(Cycle length = 28 days), and at the mandatory Safety Follow-up visits

Blood samples will be collected at Pre-dose of Cycle 1 and D1,8 of the following cycles.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Trastuzumab

Docetaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

8 mg/kg IV loading followed by 6 mg/kg Q3W IV

This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.

KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer

KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer

To estimate the disease control rate (CR + PR + SD) of KN046 in combination with trastuzumab and docetaxel. Disease control rate will include complete response (CR\], partial response (PR), and stable disease (SD), as per RECIST v1.1 criteria

To estimate the overall response rate (CR + PR) of KN035 in combination with trastuzumab and docetaxel in patients with recurrent or metastatic HER2-positive breast cancer.

• Overall Response rate will include confirmed complete response (CR) + confirmed partial response (PR), as determined as per RECIST v1.1 criteria and assessed by the local investigator

To characterize the toxicity of KN035 in combination with trastuzumab and docetaxel as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of PD-L1 Antibody KN035 in Japanese Subjects With Locally Advanced or Metastatic Solid Tumors	NCT03248843	Advanced or Met...	KN035	20 Years -	3D Medicines
89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors	NCT03638804	Solid Tumor, Ad...	89Zr-KN035	18 Years - 75 Years	The First Affiliated Hospital of Soochow University
89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors	NCT03638804	Solid Tumor, Ad...	89Zr-KN035	18 Years - 75 Years	The First Affiliated Hospital of Soochow University
Phase I Study of KN035 in Chinese Subjects With Advanced Solid Tumors	NCT03101488	Solid Tumors	KN035	18 Years - 75 Years	3D Medicines
KN035 in Patients With Advanced Multiple Primary Tumors	NCT04182789	Multiple Primar...	KN035	18 Years - 70 Years	RenJi Hospital
KN035 for dMMR/MSI-H Advanced Solid Tumors	NCT03667170	Solid Tumor	KN035	18 Years -	3D Medicines
Phase 1 Study of Anti-PD-L1 Monoclonal Antibody KN035 to Treat Locally Advanced or Metastatic Solid Tumors	NCT02827968	Solid Tumors	KN035	18 Years -	3D Medicines
KN035 in Patients With Advanced Multiple Primary Tumors	NCT04182789	Multiple Primar...	KN035	18 Years - 70 Years	RenJi Hospital
89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors	NCT03638804	Solid Tumor, Ad...	89Zr-KN035	18 Years - 75 Years	The First Affiliated Hospital of Soochow University
KN035 for dMMR/MSI-H Advanced Solid Tumors	NCT03667170	Solid Tumor	KN035	18 Years -	3D Medicines
89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors	NCT03638804	Solid Tumor, Ad...	89Zr-KN035	18 Years - 75 Years	The First Affiliated Hospital of Soochow University
A Study of PD-L1 Antibody KN035 in Japanese Subjects With Locally Advanced or Metastatic Solid Tumors	NCT03248843	Advanced or Met...	KN035	20 Years -	3D Medicines
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer	NCT04034823	HER2-positive B...	KN035 Trastuzumab Docetaxel	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for kn035

Every month we try and update this database with for kn035 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 kn035

Every month we try and update this database with for kn035 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 kn035 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.