KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03847168

Collaborator

(none)

Enrollment

Location

Arm

42.4

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Gastric/Gastroesophageal Junction Cancer	Drug: KN026	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Study of KN026 in HER2 Expressing Breast Cancer, Astric/Gastroesophageal Junction Cancer and Other Locally Advanced/Metastatic Solid Tumors

Actual Study Start Date :

Jun 18, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KN026 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 Patient will be intravenously administrated with one dose of KN026 every week or every other week.

Arm

Intervention/Treatment

Experimental: KN026

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

Patient will be intravenously administrated with one dose of KN026 every week or every other week.

Outcome Measures

Primary Outcome Measures

The proportion of patients experiencing dose limiting toxicities [From screening to up to 28 days]

Secondary Outcome Measures

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]
Time of Maximum observed serum concentration (Tmax) of KN026 [Throughout the duration of the study; up to 84 days]
Frequency and titer of anti-KN026 antibody [Throughout the duration of the study; up to 2 years]
The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria [Throughout the duration of the study; up to 2 years]
Progression free survival according to RECIST 1.1 criteria [Throughout the duration of the study; up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Greenville Health System Center Institute	Greenville	South Carolina	United States	29605

Sponsors and Collaborators

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

ClinicalTrials.gov Identifier:

NCT03847168

Other Study ID Numbers:

KN026-US-I-001

First Posted:

Feb 20, 2019

Last Update Posted:

Nov 17, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Nov 17, 2021