KN026 in Patients With HER2 Expressing Breast Cancer and... | NCT03847168

Studies
KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

NCT03847168

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Status

Unknown status

Last Update Posted

Nov 17, 2021Actual

Enrollment

22Actual

Phase

Phase 1

Conditions

Breast Cancer
Gastric/Gastroesophageal Junction Cancer

Interventions

KN026

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2019Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Feb 18, 2019

First Submission Date that Met QC Criteria

Feb 18, 2019

First Posted Date

Feb 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2021

Last Update Posted Date

Nov 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an 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 3 proposed dose levels which are 10, 15, and 20 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KN026	Experimental	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.	Drug: KN026

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KN026	Drug	Patient will be intravenously administrated with one dose of KN026 every week or every other week.	KN026

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of patients experiencing dose limiting toxicities		From screening to up to 28 days

Secondary Outcomes

Measure	Description	Time Frame
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest		From screening to up to 196 days
Maximum observed serum concentration (Cmax) of KN026		Throughout the duration of the study; up to 84 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subject >= 18 years
Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer or gastric cancer.
ECOG score 0 or 1
Life expectancy >3 months
According to the definition of RECIST1.1, the patient has at least one measurable lesion
Adequate organ function prior to start treatment with KN026
Able to understand, voluntarily participate and willing to sign the ICF
Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.

Exclusion Criteria:

Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
Accepted radiotherapy within 4 weeks before enrollment
An anthracyclines antibiotic treatment was received exceeding 300 mg/m² within 90 days before first KN026 dosing, or other equivalent dose antharcyclines
Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
Severe chronic and active infection, need to system antibiosis/antiviral treatment
Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases